Clinical Trials on the St Vincent's Integrated Healthcare Campus

The clinical trial activity on the St Vincent’s Darlinghurst Campus is conducted across many units, such as:

Translational Research Centre (AMR)
The Kinghorn Cancer Centre – Clinical Informatics and Research Centre
Heart Lung Vascular
Clinical Research Facility for the Garvan Institute
Mental Health
Palliative Care
Others (ICU, anaesthetics etc)

For a list of clinical trials currently open to recruitment on the Darlinghurst campus, please search below.

For a full list of currently recruiting clinical trials please see the Australian Clinical Trials website.

Name

Speciality

116428 (ZOSTER-039: Study to evaluate safety and immunogenicity of GSK

A Phase III, randomised, observer-blind, placebo controlled, multicentre study to assess the safety and immunogenicity of GSK Biologicals’ Herpes Zoster HZ/su candidate vaccine when administered intramuscularly on a two-dose schedule to adults aged 18 years and older with haematologic malignancies.

Dr Samuel Milliken
Chloe Martin
Haematology

3D Vis study

A pilot study of case studies to assess whether the use of three dimensional (3D) computer generated imaging to analyses de-identified MRI and CT images can be used to enhance patient understanding of neurological disease.

Dr Steven Faux
Dr Christine Shiner
Rehabilitation

64091742PCR2001 - Galahad

A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

A Dose Escalation Study to Assess the Safety and Tolerability of HMPL-453 in Patients with Advanced Solid Malignancies

A Phase I, Open-label, Multi-center, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of HMPL-453 in Patients with Advanced Solid Malignancies.

Prof Richard Epstein
Chloe Martin
Medical Oncology

A Multicenter, Open-Label, Phase 1b/2 Study To Evaluate Safety And Efficacy Of Avelumab In Combination With Chemotherapy With Or Without Other Anticancer Immunotherapies As First-Line Treatment In Pat

A Phase 1b/2, open label, multicenter, safety and clinical activity study of avelumab in combination with chemotherapy as first-line treatment of adult patients with locally advanced or metastatic solid tumors.

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

A Phase 1a/1b multicentre, open-label, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics, and anti-tumor activity of AK105 in subjects with advance solid tumors

Dr Amy Prawira
Chloe Martin
Medical Oncology

A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination with Pembrolizumab in Adult Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Dr Samuel Milliken
Chloe Martin
Haematology

A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Follicular Lymphoma (CITADEL - 203)

Dr Keith Fay
Chloe Martin
Haematology

A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in Patients with ALK-positive Advanced Lung Cancer

Dr Rachel Dear
Chloe Martin
Medical Oncology

A Phase 3 Randomised, Double-blind Active-controlled study Evaluating Momelotinib vs. Ruxolitinib in Subjects with primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-essential Thrombocythem

A Phase 3 Randomised, Double-blind Active-controlled study Evaluating Momelotinib vs. Ruxolitinib in Subjects with Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Dr Keith Fay
Yen Peng Lim
Haematology

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib

A/Prof Mark Danta
Fiona Peet
Viral Hepatitis

A Phase Ib, Open-Label, Multicenter Study Evaluating The Safety And Efficacy Of Ipatasertib In Combination With Atezolizumab And Paclitaxel Or Nab-Paclitaxel In Patients With Locally Advanced Or Metas

A Phase Ib, Open-Label, Multicenter Study Evaluating The Safety And Efficacy Of Ipatasertib In Combination With Atezolizumab And Paclitaxel Or Nab-Paclitaxel In Patients With Locally Advanced Or Metastatic Triple- Negative Breast Cancer

A/Prof Elgene Lim
Chloe Martin
Medical Oncology

A phase III, open label, randomized, multicenter trial of ofatumumab maintenance treatment versus no further treatment in subjects with relapsed chronic lymphocytic leukemia (CLL) who have responded t

A phase III, open label, randomized, multicenter trial of ofatumumab maintenance treatment versus no further treatment in subjects with relapsed chronic lymphocytic leukemia (CLL) who have responded to induction therapy

Prof David Ma
Chloe Martin
Haematology

A pilot randomised controlled trial of oral varenicline versus oral naltrexone for the treatment of alcohol dependence

AR_A pilot randomised controlled trial of oral varenicline versus oral naltrexone for the treatment of alcohol dependence

Dr Nicholas Lintzeris
Lauren Monds
Drug and Alcohol

A pilot study to explore the safety of pyridostigmine in constipated palliative care patients

A pilot study to explore the safety of pyridostigmine in palliative care patients already prescribed laxatives receiving medications that deliver an anticholinergic load and proven retention of more than 5 radiopaque markers

Prof Richard Chye
Jo Chambers
Palliative Care

A radmonised double-blind multi-site parallel arm controlled trial to assess relief of refractory breathlessness comparing fixed doses of morphine, oxycodone and placebo

A radmonised double-blind multi-site parallel arm controlled trial to assess relief of refractory breathlessness comparing fixed doses of morphine, oxycodone and placebo.

Prof Richard Chye
Sandra Montez
Palliative Care

A randomised double blind dose non-inferiority trial of aspirin in Lynch syndrome. CaPP3

A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3)

Prof Allan Spigelman
Chloe Martin
Medical Oncology

A randomised trial of Telehealth intervention for patient’s post-HSCT

A randomised trial of a telehealth programme of combined physical and psychological training in patients following Hematopoietic Stem Cell Transplant (HSCT)

Prof David Ma
Cloe Martin
Haematology

A randomized clinical trial comparing effectiveness of 4RIF and 9INH for treatment of latent TB infection

A randomised controlled trial comparing 9 months Isoniazid (INH) to 4 months Rifampicin (RIF) as therapy for latent TB infection

A/Prof Marshall Plit
A/Prof Marshall Plit
Thoracic / Lung

A Randomized Controlled Trial of Photodynamic Therapy vs Radiotherapy for Superficial Skin Cancer

Dr Gerald Fogarty
Chloe Martin
Radiation Oncology

A randomized, double-blind, multi-site, parallel arm controlled trail to assess relief of refractory breathlessness comparing oral sertraline and placebo.

Prof Richard Chye
Penny West
Palliative Care

A Randomized, Open-label, Phase 3 Study in subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in combination with Dexamethasone, Comparing Once-weekly versus Twice-weekly Car

A Randomized, Open-label, Phase 3 Study in subjects with Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in combination with Dexamethasone, Comparing Once-weekly versus Twice-weekly Carfilzomib Dosing (A.R.R.O.W.)

Dr Keith Fay
Chloe Martin
Haematology

A Study of MGA012 in Patients with Advanced Solid Tumors

A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of MGA012 in Patients with Advanced Solid Tumors

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg versus 80 kBq/kg, and versus 50 kBq/kg in an extended dosing schedule in subjects with castration-resistant prostat

A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg versus 80 kBq/kg, and versus 50 kBq/kg in an extended dosing schedule in subjects with castration-resistant prostate cancer metastatic to the bone

Prof Richard Epstein
Sandra Montez
Medical Oncology

A1481324

A1481324 A multinational, multicentre study to assess the effects of oral Sildenafil on mortality in adults with Pulmonary Arterial Hypertension (PAH)

Prof Anne Keogh
Annette Pidoux
Cardiopulmonary Transplant

AbbVie AD M15-566

Clinical Study Protocol M15-566 - A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects with Early Alzheimer's Disease.

Professor Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

ABBVIE M13-576

A Follow-up Study to Assess Resistance and Durability of Response to Abbvie Direct-Acting Antiviral Agent (DAA) Therapy (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection.

Professor Greg Dore
Alison Sevehon
Viral Hepatitis

ABC - Anti-P D 1 Brain Collaboration Study

A phase II study of nivolumab and nivolumab combined with ipilimumab in patients with melanoma brain metastases

Dr Lisa Tarlinton
Sandie Gierson
Nuclear Medicine

ABI-007-PANC-003

A Phase 3, Multi-centre, Open-label, Randomized Study of nab®-Paclitaxel Plus Gemcitabine versus Gemcitabine alone as Adjuvant Therapy in subjects with Surgically Resected Pancreatic Adenocarcinoma

Prof Richard Epstein
Lalith Ratnayake
Medical Oncology

ABI-1968-201: Study of Topical ABI-1968 in Subjects with aHSIL

ABI-1968-201: Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects with Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

Prof Richard Hillman
Trish Chronopoulos
Immunology

ACE-CL-006

A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia (ACE-CL-006)

Prof David Ma
Chloe Martin
Haematology

ACE-CL-007

A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination with Chlorambucil, ACP-196 in Combination with Obinutuzumab, and ACP-196 Monotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia (ACE-CL-007)

Prof David Ma
Chloe Martin
Haematology

ACED

A Phase II randomised placebo-controlled, double blind, multisite study of Acetazolamide versus placebo for management of cerebral oedema in recurrent and/or progressive High Grade Glioma requiring treatment with Dexamethasone

Dr Cecelia Gzell
Chloe Martin
Radiation Oncology

aCRT Study

Adaptive Cardiac Resynchronization Therapy (aCRT) Study

Bruce Walker
Robyn Walker
Cardiology

AdaptHIV

A Randomised Controlled Trial (RCT) of AdaptHIV, an internet Cognitive Behavioural Therapy (iCBT) program for the treatment of depression and anxiety in men who have sex with men (MSM) who are living with HIV

Prof Gavin Andrews
Dr Michael Millard
Anxiety/CRUFAD

AdaptResponse

AdaptResponse Study

Prof Christopher Hayward
Clare Coated
Cardiopulmonary Transplant

ADAURA

A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, study to assess the efficacy and safety of AZD9291 versus Placebo, in Patients with Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, following Complete Tumour Resection With or Without Adjuvant Chemotherapy

Dr Rachel Dear
Chloe Martin
Medical Oncology

ADRENAL - ADjunctive coRticosteroid trEatment iN criticAlly ilL patients

A randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with septic shock - ADRENAL

Priya Nair
Claire Reynolds
Intensive Care

ADVICE

Attenuation of D-dimer using Vorapaxar to target Inflammatory and Coagulation Endpoints. A double blind randomised comparison of vorapaxar versus placebo for the treatment of HIV associated Inflammation and coagulopathy in patients with well controlled HIV replication.

Professor Cooper/Kelleher
Florence Bascombe
HIV

AGOC

A randomised phase III double-blind placebo-controlled study of regorafenib in refractory Advanced Gastro-oesophageal Cancer

Prof Richard Epstein
Chloe Martin
Medical Oncology

AHOD/DAD/RESPOND

The Australian HIV Observational Database

Prof Andrew Carr
Florence Bascombe
HIV

AI438047/205888

A Multi-arm, Phase 3, Randomised, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068/GSK3684934 in Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant HIV-1

Prof Andrew Carr
Nicola Mackenzie
Immunology

AK 104-101

A Phase 1a/b multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, pharmacokinetics, and anti-tumor activity of AK 104 in subjects with advanced solid tumors.

Dr Amy Prawira
Chloe Martin
Medical Oncology

Alectinib versus crizotinib in treatment-naive ALK Positive advanced non-small cell lung cancer - ALEX study

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib In Treatment-Naïve Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

Dr Rachel Dear
Ashley Douglas
Medical Oncology

ALLG MDS4; AZA v LEN AZA in MDS

A Randomised Phase II study comparing the efficacy of 5azacitidine alone versus combination therapy with lenalidomide and 5azacitidine in patients with higher risk myelodysplastic syndromes (MDS) and low marrow blast count acute myeloid leukaemia (AML).

Dr Keith Fay
Chloe Martin
Haematology

ALLG MM11

A phase 3, multicentre, randomised, controlled study to determine the efficacy and safety of cyclophosphamide,lenalidomide and dexamethasone (CRD) versus melphalan (200mg/m2) followed by stem cell transplantation in newly diagnosed multiple myeloma subjects.

Dr Samuel Milliken
Chloe Martin
Haematology

ALLG MM19

A Phase 3 trial of thalidomide-dexamethasone consolidation versus thalidomide-dexamethasone-Ixazomib consolidation for transplant eligible multiple myeloma patients undergoing a single ASCT as part of front-line therapy

A/Prof John Moore
Chloe Martin
Haematology

ALX0171-C204

A randomized, double-blind, multicenter study to evaluate the efficacy and safety of ALX 0171 versus placebo, in addition to standard of care, in adults who have undergone hematopoietic stem cell transplantation and present with a respiratory syncytial virus respiratory tract infection

Dr Nada Hamad
Chloe Martin
Haematology

ALX0681-C301

A Phase III Double-Blind, Randomized, Parallel Group, Multicenter Placebo-Controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients with Acquired Thrombotic Thrombocytopenic Purpura

Dr Keith Fay
Chloe Martin
Haematology

AM0010-301

A Randomised Phase 3 Study of AM0010 in Combination with FOLFOX Compared with FOLFOX Alone as Second-line Therapy in Patients with Metastatic Pancreatic Cancer that has Progressed During or Following a First-Line Gemcitabine Containing Regimen

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

AMC-095

Phase I study of Ipilimumab and Nivolumab in Advanced HIV Associated Solid Tumors with an expansion Cohort in HIV Associated Solid Tumors.

Dr Mark Polizzotto
Rob Kent
HIV Oncology Studies

Amgen 20160275

A Randomized, Open-label, Phase 3 Study Comparing Carfilzomib, Dexamethasone, and Daratumumab to Carfilzomib and Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Dr Keith Fay
Chloe Martin
Haematology

AMRMRI15

Validation of a novel MRI protocol for detection of amyloid brain burden in Alzheimer’s disease: A pilot study.

Professor Bruce Brew
Fiona Kilkenny
Neurology / Alzheimer’s Disease

An Extended Access Program To Assess Long Term Safety Of Bardoxolone Methyl - Ranger

An Extended Access Program To Assess Long Term Safety Of Bardoxolone Methyl In Patients With Pulmonary Hypertension

Prof Anne Keogh
Peta Brydon
Cardiopulmonary Transplant

An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined with Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/Refractory Follicular Lymphoma

Dr Nada Hamad
Chloe Martin
Haematology

An open label, multi-center, Phase IV roll-over protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study and are judged by the investigator to be

An open label, multi-center, Phase IV roll-over protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study and are judged by the investigator to benefit from continued treatment

Prof David Ma
Chloe Martin
Haematology

Anavex

A Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled 48-week Safety and Efficacy trial of ANAVEX2-73 for the Treatment of Early Alzheimer’s Disease (AD)

Prof. Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

ANTIVA

Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Topical ABI-1968 in Subjects with Anal High-Grade Squamous Intraepithelial Lesions (aHSIL)

Dr Richard Hillman
Daniel Seeds
Anal Cancer/HIV

APD811-007

An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension

Prof Anne Keogh
Karen Brown
Cardiopulmonary Transplant

APML5: bioavailability of oral arsenic trioxide in consolidation therapy for APL

A phase I pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia

Dr Nada Hamad
Chloe Martin
Medical Oncology

AREISSA

Altering the rehabilitation environment to improve stroke survivor activity (AREISSA): a phase II trial.

Dr Steven Faux
Christine Shiner
Rehabilitation

ASCOLT

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers. An International, Multi-centre, Double Blind, Randomised Placebo Controlled Phase III Trial.

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

ASSIST-CLAD Study

ASSIST – CLAD study

Prof Allan Glancille
Ian Wu
Thoracic / Lung

AURA3

A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

Dr Rachel Dear
Ashley Douglas
Medical Oncology

BAY 94-9343 / 15834

Phase 1b multi-indication study of anetumab ravtansine (BAY 94-9343) in patients with mesothelin expressing advanced or recurrent malignancies

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

BBI608-336 brighter

A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of BBI608 Plus Weekly Paclitaxel Vs. Placebo Plus Weekly Paclitaxel In Adult Patients with Advanced, Previously Treated Gastric and Gastro-Esophageal Junction (GEJ) Adenocarcinoma

Prof Richard Epstein
Chloe Martin
Medical Oncology

BEAMS

A pragmatic, phase III, multi-site, double-blind, placebo controlled, parallel arm, dose increment randomised trial of regular, low dose extended release morphine for chronic refractory breathlessness.

Prof Richard Chye
Frances Bellemore
Palliative Care

BGB-290-103

A Phase 1b study to assess the safety, tolerability and clinical activity of BGB-290 in combination with temozolomide (TMZ) in subjects with locally advanced or metastatic solid tumors

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

Biogen BIIBO37

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects with Early Alzheimer's Disease.

Professor Bruce Brew
Fiona Kilkenny
Neurology

BLAM - A phase IIb study of Blinatumomab + Cytarabine (AraC) and Methotrexate in adult B-precursor Acute Lymphoblastic Leukaemia

A/Prof John Moore
Chloe Martin
Haematology

BLING II

A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients.

Dr Sam Rudham
Claire Reynolds
Intensive Care

BOSTON: Bortezomib, Selinexor, and Dexamethasone in Patients with Multiple Myeloma

A Phase 3 Randomized, Controlled, Open-Label Study of Selinexor, Bortezomib, and Dexamethasone (SVD) Versus Bortezomib and Dexamethasone (VD) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM).

Dr Nada Hamad
Chloe Martin
Haematology

CA017-003

A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab (anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclocal Antibody) in Advanced Malignant Tumors

A/Prof Anthony Joshua
Carolyn Pieri
Medical Oncology

CAMERA

Combination Antibiotic treatment for Methicillin Resistant Staphylococcus aureus

Dr David Andresen
Dr David Andresen
Immunology

CAMERA2

CAMERA 2 Combination Antibiotic Therapy for Methicillin Resistant Staphylococcus Aureus infection – An investigator-initiated, multicentre, parallel group, open labelled randomised controlled trial.

Dr David Andresen
Dr David Andresen
Immunology

CanStem303C (aka BB608-303CRC)

A Phase III Study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC).

Prof Richard Epstein
Chloe Martin
Medical Oncology

Cardiac MR in Cardiac Transplant Rejection

Randomised Safety Outcomes Study Comparing Patients Diagnosed and Treated for Acute Cardiac Rejection on Cardiac MRI Compared to Endomyocardial Biopsy

Dr Chris Anthony
Dr Chris Anthony
Cardiology

CATALYST

A study of the efficacy and safety of Bardoxolone methyl in patients with connective tissue disease-associated pulmonary arterial hypertension.

N/A
Peta Brydon
Pulmonary Hypertension

CC-90001-CP-003

A Phase 1b, Multicenter, Open-Label, Staggered-Dose Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of Cc-90001 For 12 Weeks In Subjects With Pulmonary Fibrosis

Prof Allan Glanville
Lee Mead
Thoracic / Lung

CC-90001-IPF-001

A Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, Followed by a 28-Week Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis

Prof Allan Glanville
Lee Mead
Thoracic / Lung

CEASE/ISTEP

Control and Eradication within Australia of Hepatitis C from people living with HIV (Surveillance Phase).

Dr Gail Mathews
Fiona Peet/Alison Sevehon
Viral Hepatitis

CELESTIAL

To evaluate the effect of Cabozantinib compared with placebo on overall survival in subjects with advanced HCC previously treated with Sorafenib.

Dr Mark Danta
Fiona Peet
Viral Hepatitis

Checkmate 651 CA209-651

An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination with Ipilimumab versus Extreme Study Regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Dr Vanessa Chin
Chloe Martin
Medical Oncology

CheckMate 9ER: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9ER

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (CA209-9ER).

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

Chronos 4

A Phase III, randomized, double-blind, controlled, multicentre study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed incident non-Hodgkin’s lymphoma (iNHL)

Dr Keith Fay
Chloe Martin
Medical Oncology

CINC424D2301 - REACH 3

A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft vs host disease after allogenic stem cell transplantation (REACH 3)

Dr Nada Hamad
Chloe Martin
Haematology

CL3-95005-004

An open-label early access phase IIIb study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated metastatic colorectal cancer

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

Clinical Trial Evaluation of the Percutaneous 4TECH TriCinch Coil Tricuspid Valve Repair

Prof David Muller
Erika O'Dea
Cardiology

COG RX 2

A randomized, double-blind, placebo-controlled, parallel-group, phase 2 Study to evaluate the safety and efficacy of ct1812 in subjects with mild to moderate Alzheimer’s disease

Prof. Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

CogRX- phase 1

A double-blind, placebo-controlled, phase I study of the safety and pharmacokinetics of two doses of ct1812 in subjects with mild to moderate alzheimer’s disease.

Professor Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

CombiRT - RT & combi in metastatic melanoma

An open-label, single-arm, phase I/II, multicentre study to evaluate the safety and efficacy of the combination of dabrafenib, trametinib and palliative radiotherapy in patients with unresectable (stage IIIc) and metastatic (stage IV) BRAF V600E/K mutation-positive cutaneous melanoma (ANZMTG 02.14)

Dr Gerald Fogarty
Chloe Martin
Radiation Oncology

Confocal EndoMicroscopy Optimisation Research-HIV/IBD

Confocal EndoMicroscopy Optimisation Research-HIV and IBD (CEMOR-HIV/IBD) study

A/Prof Mark Danta
A/Prof Mark Danta
Endoscopy

Controlled trial of a decision aid for ulcerative colitis patients: enhancing patient's quality of life, empowerment, quality decision making and disease control.

Dr Simon Ghaly
Sasha Ruban
Gastroenterology

CP-MGA271-03

A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination with Pembrolizumab in Patients with Melanoma, Squamous Cell Cancer of the Head and Neck, Non-Small Cell Lung Cancer, Urothelial Cancer, and Other Cancers

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

CP-MGD009-01

A Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Patients with Unresectable or Metastatic B7-H3-Expressing Neoplasms and Neoplasms whose Vasculature Expresses B7-H3

Dr Amy Prawira
Chloe Martin
Medical Oncology

CRUSADES

Charcot Foot Quantitative Ultrasound and Denosumab Study

Dr Joel Lasschuit
Dr Joel Lasschuit
Endocrinology

CS1003-101

A Phase Ia/Ib, Open-Label, Multi-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects with Advanced Solid Tumors

Dr Amy Prawira
Chloe Martin
Medical Oncology

D3FEAT

A phase IV open-label, multicentre, international trial of paritaprevir/ritonavir, ombitasvir, dasabuvir and ribavirin for people with chronic hepatitis C virus genotype 1 infection and recent injection drug use or receiving opiate substitution therapy

A/Prof Gail Matthews
Fiona Peet
Viral Hepatitis

D4190C00006

A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination with Tremelimumab in Subjects with Advanced Non-small Cell Lung Cancer

Dr Rachel Dear
Chloe Martin
Medical Oncology

DARE - C - II

Directly-acting antiviral (DAA) based therapy for recently acquired Hepatitis C II.

Prof Gregory Dore
Fiona Peet
Viral Hepatitis

DARLO-C

Scale-up of treatment for hepatitis C infection among people who inject drugs: A phase IV, open-label, single arm, multicentre trial of elbasvir/grazoprevir for genotype 1 or 4 in people with chronic hepatitis C virus infection and recent injecting drug use.

Professor Greg Dore
Fiona Peet
Viral Hepatitis

De-labelling patients with antibiotic allergy in Sydney adult and paediatric hospital allergy services-towards standardisation and improved patient outcomes

Dr Winnie Wing Yin Tong
Robyn Richardson
Immunology

DETECT trial

Radioguided Surgery With Technetium99m-labelled PSMA To Aid Intra-operative Lymph Node Metastases Detection For Patients Undergoing RARP For Prostate Cancer

Prof Phillip Stricker
Quoc Nguyen
Urology

Determination of febuxostat plasma concentrations by HPLC with fluorescence-detection in healthy subjects

Prof Richard Day
Bishoy Kamel
Pharmacology

Diabetes and writing study

Internet-based benefit finding writing for adults with diabetes: Feasibility testing and a randomised controlled trial

Kay Wilhelm
Joanna Crawford
Psychiatry

Dose Optimization Study of Idelalisib in Follicular Lymphoma (GS-US-313-1580)

A/Prof John Moore
Chloe Martin
Haematology

DUOGLOBE

DUOdopa/Duopa in Patients with Advanced Parkinson's Disease (PD) –a GLobal OBservational Study Evaluating Long-Term Effectiveness.

Stephen Tisch
Marko Garcia
Parkinsons Disease

ECHELON - 2

A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas.

Dr Keith Fay
Chloe Martin
Haematology

Echocardiographic and haemodynamic assessment of LVAD patients

Short and long-term changes in left ventricular function in patients with left ventricular assist device: echocardiographic and invasive haemodynamic assessment

Prof Christopher Hayward
Dr Pankaj Jain
Cardiology

Efficacy and safety of SAR156597 in the treatment of Idiopathic Pulmonary Fibrosis (IPF): A randomized, double-blind, placebo-controlled, 52-week dose ranging study (ESTAIR)

Prof Allan Glanville
Lee Mead
Thoracic / Lung

EISAI

A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease

Prof. Bruce Brew
Jolyon Minshall
Neurology / Alzheimer’s Disease

EMR 200104011

AR_Open-label, single-arm, phase IV, multicenter trial to explore the immunogenicity of the liquid formulation of Saizen® in subjects with growth hormone deficiency (GHD) of adult onset.

Dr Ann McCormack
Lyn Schofield
Endocrinology

ENGAGE PWS

The effects of a new GLP-1 agonist on appetite and gastric emptying in Prader-Willi syndrome

Prof Lesley Campbell
Amanda Hor
Cardiopulmonary Transplant

ENZAMET Trial

A randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer

Prof Richard Epstein
Lalith Ratnayake
Medical Oncology

ENZARAD Trial

A randomised phase 3 trial of enzalutamide in androgen deprivation therapy for high risk, clinically localised, prostate cancer.

Dr Raj Jagavkar
Chloe Martin
Medical Oncology

EPIC

Impact of the rapid expansion of pre-exposure prophylaxis (PrEP) on HIV incidence, in a setting with high HIV testing and antiretroviral treatment coverage, to achieve the virtual elimination of HIV transmission by 2020: a NSW HIV Strategy implementation project.

Professor Andrew Carr
John McAllister/ Sarah Holiday
HIV

Erythropoietin in Traumatic Brain Injury EPO-TBI

A randomised, placebo-controlled trial of erythropoietin in ICU patients with traumatic brain injury.Erythropoietin in Traumatic Brain Injury EPO-TBI

Priya Nair
Claire Reynolds
Intensive Care

Evaluation of Radium-223 in combination with Abiraterone in CRPC - ERA 223 (Radium lll)

A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)

Prof Richard Epstein
Chloe Martin
Medical Oncology

Evolut R Low Risk

Transcatheter Aortic Valve Replacement (TAVR) with the Medtronic Transcatheter Aortic Valve Replacement System (TAVR) in Patients at Low Risk for Surgical Aortic Valve Replacement (SAVR) EvolutR low risk study

Prof David Muller
Erika O'Dea
Cardiology

ExPAH

The effect of an outpatient exercise training program on haemodynamic and cardiac magnetic resonance parameters of right ventricular function in patients with pulmonary arterial hypertension.

A/Prof Eugene Kotlyar
Dr Christine Shiner
Rehabilitation

ExPAH - Optional

Optional adjunct study to the ExPAH study - investigating dynamic right heart haemodynamic via exercise during right heart catheter procedure

A/Prof Eugene Kotlyar
Dr Christine Shiner
Rehabilitation

Expanded PrEP Implementation in Communities in NSW (EPIC-NSW)

Impact of the rapid expansion of pre-exposure prophylaxis (PrEP) on HIV incidence, in a setting with high testing and ART coverage, to achieve the virtual elimination of HIV transmission by 2020: a NSW HIV Strategy Implementation Project.

Prof Andrew Carr
Florence Bascombe
Immunology

EXPEDITION-2

Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 – 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)

A/Prof Gail Matthews
Fiona Peet
Viral Hepatitis

EXPERT: EXamining PErsonalised Radiation Therapy for low-risk early breast cancer.

ANZ 1601/BIG 1602/ EXPERT: A randomised phase III trial of adjuvant radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer

Dr Joanne Toohey
Bianca Karle
Radiation Oncology

EXTEND

Extending the time for Thrombolysis in Emergency Neurological Deficits

A/Prof Romesh Markus
Florence Bascombe
Neurology

FACTS - F actor concentrates versus A llogeneic blood products in bleed

A Randomised,single centre trial comparing the use of factor concentrates versus fractionated,allogeneic blood products using treatment algorithms based on point of care whole blood viscoelastic tests/platelet function tests in patients bleeding post cardiac surgery

David Lowe
David Lowe
Intensive Care

FANTOM II Trial

Safety and Performance Study of the FANTOM Sirolumus-eluting bioresorbable coronary scaffold

Prof David Muller
Erika O'Dea
Cardiology

FGCL-4592-082

A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome (MDS) with Low Red Blood Cell (RBC) Transfusion Burden (LTB)

Dr Keith Fay
Chloe Martin
Medical Oncology

FIB audit

Patients with fractured neck of femur- pain assessment and management surgical and non-surgical from 0-72 hours

A/Prof Steven Faux
Dr Christine shiner
Rehabilitation

FILGOTINUB

Combined Phase 3, Double Blind, randomized, Placebo-Controlled Studies evaluating the Efficacy and Safety of Filgotinib in the induction and maintenance of remission subjects with moderately to severely active Crohn’s Disease.

Dr Simon Ghaly
Fiona Peet / Alison Sevehon
Irritable Bowel Disease

FLU PLUS 003

An International Observational Study to Characterize Adults Who Are Hospitalized with Influenza or Other Targeted Respiratory Viruses (MERS-CoV & SARS-CoV)

Prof. Anthony Kelleher
Florence Bascombe
Immunology

GALACTIC HF

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction.

N/A
Carmen Herrera
Heart Failure

GALACTIC-HF STUDY

Peter Macdonald
Carmen Herrera
Heart Failure

GB28547

A Phase II Randomized double blind placebo controlled study to assess the efficacy and safety of lebrikizumab in patients with idiopathic pulmonary fibrosis

Prof Allan Glanville
Lee Mead
Cardiopulmonary Transplant

GEMINI 1 204861

Phase 3 Randomised double blind, multicentre, parallel group, non inferiority study evaluating the safety, efficacy and tolerability of Dolutegravir and Lamivudine compared to Dolutegravir plus Tenofovir Lemtricitabine in HIV-1 infected treatment naïve adults.

Professor Cooper/Kelleher
Florence Bascombe
HIV

Generation 1

A randomized, double-blind, placebo-controlled, two-cohort parallel group study to evaluate the efficacy of CAD106 and CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer's disease

Prof. Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

Generation 2

A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer’s Disease (AD)

Prof. Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

GENETECH

A phase ii, multicentre, randomized, double-blind, placebo-controlled, Parallel-group, efficacy, and safety study of mtau9937a in patients with prodromal to mild Alzheimer’s disease

Prof. Bruce Brew
Sarah Barney
Neurology / Alzheimer’s Disease

GENOMICS (Flu 004)

Influenza Genomics Study-A substudy of qualifying INSIGHT FLU studies

Prof. Anthony Kelleher
Florence Bascombe
Immunology

Gilead 0115

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in combination with Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

Prof David Ma
Yen Peng Lim
Haematology

GO28888 LORELEI

A Phase Ii Randomized, Double-Blind Study Of Neoadjuvant Letrozole Plus Gdc-0032 Versus Letrozole Plus Placebo In Postmenopausal Women With Er-Positive/Her2-Negative, Early Stage Breast Cancer

Prof Richard Epstein
Ashley Douglas
Medical Oncology

GO29438

Phase III Open-Label Randomised Study of Atezolizumab in Combination with Carboplatin or Cisplatin+Pemetrexed Compared with Carboplatin or Cisplatin+Pemetrexed in Patients who are Chemotherapy Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer

Dr Rachel Dear
Chloe Martin
Medical Oncology

GO29689

A Phase Ii, Open-Label, Randomized Study Of Gdc-0810 Versus Fulvestrant In Postmenopausal Women With Advanced Or Metastatic Er + /Her2 − Breast Cancer Resistant To Aromatase Inhibitor Therapy

A/Prof Elgene Lim
Chloe Martin
Medical Oncology

GO30103

A Phase Ia/Ib Open-Label, Dose Escalation Study Of The Safety And Pharmacokinetics Of Mtig7192a As A Single Agent And In Combination With Atezolizumab In Patients With Locally Advanced Or Metastatic Tumors

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

GO39932

A Phase Ia/Ib, Multicenter, Open-Label, Dose Escalation, Dose Expansion Study Evaluating The Safety, Pharmacokinetics, And Activity Of GDC-9545 Alone Or In Combination With Palbociclib And/Or Lhrh Agonist In Patients With Locally Advanced Or Metastatic Estrogen Receptor−Positive Breast Cancer

A/Prof Elgene Lim
Chloe Martin
Medical Oncology

GRAVITAS-301

A Randomized, Double Blind, Placebo Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First Line Acute Graft-Versus-Host Disease

Dr Nada Hamad
Chloe Martin
Haematology

GRIPHON OL: Prostacyclin (PG12) Receptor agonist in pulmonary arterial

Long-term single-arm open-label study to assess the safety and tolerability of Selexipag (ACT-293987) in patients with pulmonary arterial hypertension

A/Prof Eugene Kotlyar
Annette Pidoux
Cardiopulmonary Transplant

GSK 205888 (BMS-AI428-047)

A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068/GSK3684934 in Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant HIV-1

Prof. Anthony Kelleher
Florence Bascombe
HIV

GS-US-296-1080

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS 5745 Combined with mFOLFOX6 as First Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma - country

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

GS-US-380-1844

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects who are Virologically Suppressed.

Prof Anthony Kelleher
Florence Bascombe
Immunology

GS-US-380-1878

A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Boosted Atazanavir or darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults .

Prof Anthony Kelleher
Florence Bascombe
Immunology

GS-US-384-1943

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

A/Prof Mark Danta
Fiona Peet
Gastroenterology

GS-US-384-1944

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)

A/Prof Mark Danta
Fiona Peet
Gastroenterology

GS-US-418-3898

GS-US-418-3898 Combined Phase 2b/3, Double- Blind, Randomized. Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis

Dr Simon Ghaly
Fiona Peet
Gastroenterology

GS-US-418-3899

GS-US-418-3899 A Long Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Ulcerative Colitis

Dr Simon Ghaly
Fiona Peet
Gastroenterology

GS-US-419-3895

GS-US-419-3895 Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn’s Disease

Dr Simon Ghaly
Fiona Peet
Gastroenterology

GS-US-419-3896

GS-US-419-3896 A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn's Disease

Dr Simon Ghaly
Fiona Peet
Gastroenterology

GTi1201- VIC/NSW/QLD_SSA

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1 Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alpha1 Antitrypsin Deficiency

Prof Allan Glanville
Lisa Singleton
Cardiopulmonary Transplant

GTx Protocol Number: G200802

A Phase 2 Open Label, MultiCenter, Multinational, Randomized, Parallel Design Study Investigating The Efficacy and Safety Of GTx024 on Metastatic or Locally Advanced ER+/AR+ Breast Cancer (BC) in Postmenopausal Women

A/Prof Elgene Lim
Chloe Martin
Medical Oncology

HALO-109-301

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Milticenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination with nab-Paclitaxel Plus Gemcitabine Compared with Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma.

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

HANMI NSCLC

A single-arm, open-label, Phase 2 study evaluating the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor

Dr Rachel Dear
Chloe Martin
Medical Oncology

Haplo transplant with PTCy

A phase II trial of haploidentical peripheral blood stem cell transplantation with post- transplant cyclophosphamide as GVHD prophylaxis.

A/Prof John Moore
Chloe Martin
Haematology

HI-C

HIV and Immunity Cancer cohort study. A non-interventional biobanking study - Kirby.

Dr Mark Polizzotto
Florence Bascombe
HIV Oncology Studies

High-flow nasal cannula versus low-flow nasal cannula oxygenation in lung transplant patients undergoing diagnostic transbronchial biopsy: A randomised controlled trial

Dr Charles Cartwright
Dr Charles Cartwright
Anaesthetics

HIV Latency

The identification and quantification of HIV CNS latency biomarkers.

Professor Bruce Brew
Jolyon Minshall
Neurology

HIV SCT

Blood and tissue collection of patients with HIV-1 infection undergoing allogeneic haematopoietic stem cell transplantation.

Dr Mark Polizzotto
Florence Bascombe
HIV

HS110201

Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS110) in Combination with Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients with Non-Small Cell Lung Adenocarcinoma after Failure of Two or Three Previous Treatment Regimens for Advanced Disease

Dr Rachel Dear
Ashley Douglas
Haematology

HSCT for Auto-Immune Diseases

A Single Centre Phase II Study of Haematopoietic Stem Cell Transplantation For Severe Auto-Immune Diseases

A/Prof John Moore
Chloe Martin
Haematology

I3Y-MC-JPCJ

An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination with Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

I8S-MC-JUAB

A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996)Administered Alone or in Combination with Other Agents in Advanced Cancer

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

I8X-MC-JECA

A Phase 1 Study of LY3200882 in Patients with Solid Tumors

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

iCanADAPT RCT

A Randomised controlled Trial (RCT) of iCanADAPT, an internet Cognative Behavioural Therapy (iCBT) programe for the treatment of depression and anxiety in early-stage cancer patients and cancer survivors

Dr Alison Mahoney
Jessica Smith
Anxiety/CRUFAD

iCHIP

Effect of Immune Checkpoint Inhibitors on HIV Persistence: An observational study among HIV patients with cancer

Dr Mark Polizzotto
Florence Bascombe
HIV Oncology Studies

ICURE

A multinational, multi-centre, randomized, double-blind, active comparator, phase III clinical trial to evaluate the efficacy and safety of donepezil transdermal patch in patients with Alzheimer’s disease

Prof. Bruce Brew
Joshua Carey
Neurology / Alzheimer’s Disease

IMCgp-100-202

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

INCB 39110-230

An Open-Label, Multiple Simon 2-Stage Study of INCB03911 Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera-Myelofibrosis (PPVMF) or Post Essential Thrombocythemia-Myelofibrosis (PET-MF)

Prof David Ma
Chloe Martin
Haematology

INCB 50465-202

A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Dr Keith Fay
Chloe Martin
Haematology

INOvation-1

A Phase 3, Placebo Controlled, Double-blind, Randomized, Clinical Study to Determine Efficacy, Safety and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) versus Placebo in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH): INOvation-1 (Part 1 and Part 2)

Prof Anne Keogh
Annette Pidoux
Cardiopulmonary Transplant

InTENSE

The InTense Trial: optimising upper limb recovery following stroke.

Dr Steven Faux
Christine Shiner
Rehabilitation

INTERHEART

Diagnostic and Therapeutic Application of Microarrays in Heart Transplantation, a Multicenter Study.

N/A
Carmen Herrera
Heart Failure

International Revalving Registry. Percutaneous Aortic Valve Replacement (PAVR) with the Corevalve Revalving System

Prof David Muller
Erika O'Dea
Cardiology

ITACS

IV Iron for Treatment of Anaemia before Cardiac Surgery

James Yeates
James Yeates
Anaesthetics

Janssen - EARLY

A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Study Investigating the Efficacy and Safety of JNJ-54861911 in Subjects who are Asymptomatic At Risk for Developing Alzheimer’s Dementia.

Professor Bruce Brew
Fiona Kilkenny
Neurology / Alzheimer’s Disease

JPCF

MonarchE: Protocol I3Y-MC-JPCF A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

A/Prof Elgene Lim
Chloe Martin
Medical Oncology

KCP-330-009: A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Dr Nada Hamad
Chloe Martin
Haematology

KEYNOTE-365

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

LIMA

A randomised double blind placebo controlled study of lisdexamfetamine for the treatment of methamphetamine dependence

A/Prof Nadine Ezard
Teodora Zanesheva
Drug and Alcohol

Long Term Non-Progression Study

Long-Term non-progression in people with HIV Infection

Prof Anthony Kelleher
Immunology

LUPIN trial

Radionuclide therapy using 177Lu-PSMA: a phase I study in men with castrate-resistant prostate cancer to determine the clinical benefit of combination therapy with idronoxil

A/Prof Louise Emmett
Chloe Martin
Nuclear Medicine

LuPSMA Trial

Radionuclide therapy using 177Lu-PSMA: a pilot study in men with castrate-resistant prostate cancer

A/Prof Louise Emmett
Chloe Martin
Nuclear Medicine

M14-423

Protocol M14-423: An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)

Prof Gregory Dore
Fiona Peet
Viral Hepatitis

M15-654: A Phase 1/2, Multicenter, Open-Label Dose-Escalation and Blinded Expansion Study of Venetoclax, Daratumumab and Dexamethasone Combination Therapy in Subjects with Relapsed or Refractory Multi

A Phase 1/2, Multicenter, Open-Label Dose-Escalation and Blinded Expansion Study of Venetoclax, Daratumumab and Dexamethasone Combination Therapy in Subjects with Relapsed or Refractory Multiple Myeloma

Dr Keith Fay
Chloe Martin
Medical Oncology

MAGNIFI Trial

Metastasis assessment with Gallium-68 PSMA and Nanoparticle Imaging Fusion International

A/Prof Anthony Joshua
Quoc Nguyen
Medical Oncology

Mapping Reservoir

HIV infected patient on successful suppressive antiviral therapy blood collection.

Dr Kelleher
Florence Bascombe
HIV

Mapping Study

Integrating NSW/ACT healthcare for stroke and hip fracture - Mapping the relationship between the availability of outpatient services and inpatient rehabilitation length of stay in NSW/ACT hospitals.

Dr Steven Faux
Angela Vratsistas-Curto
Rehabilitation

Maxigesic RCT

A RCT of Paracetamol, Ibuprofen and their combination in the outpatient treatment of acute moderate to severe musculoskeletal pain within the first five days of its onset

Paul Preisz
Joseph Elkadi
Emergency Department

MDV3800 06

A Phase 2, Open-Label, 2-Arm, Response Rate Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and/or Abiraterone Acetate/Prednisone)

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

Medicinal Cannabis for anorexia in advanced cancer

Phase II, dose ranging study of the pharmacokinetics dose-response parameters, and feasibility of vaporised botanical leaf cannabis

Prof Richard Chye
Penny West
Palliative Care

Megestrol, dexamethasone and placebo for anorexia

Randomised, double blind control trial of megestrol acetate, dexamethasone and placebo in the management of anorexia in patients with cancer

Prof Richard Chye
Penny West
Palliative Care

Memory B-Cell/HBV

Determining the unique processes that control memory B cell-mediated secondary antibody responses

Dr Tuong Phan
Florence Bascombe
Immunology

Metformin in heart failure

The safety and pharmacokinetics of metformin in heart failure

Prof Richard Day
Felicity Smith
Pharmacology

MK-5172 in Combination with MK-8742 in Subjects on Opiate Substitution Therapy

A Phase III, Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naive Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection who are on Opiate Substitution Therapy.

Prof Gregory Dore
Fiona Peet
Viral Hepatitis

MoST substudies 6-8: Olaparib plus Durvalumab

Molecular Screening and Therapeutics (MoST) Program Substudies 6 – 8: Single arm, open label, signal seeking, phase IIa trial of the activity of Olaparib in combination with Durvalumab in patients with tumours with homologous recombination repair defects

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

MoST Substudy 1 - Palbociclib for cancer

Molecular Screening and Therapeutics (MoST) Program Substudy 1 – Single arm, open label, signal seeking, phase Ib/IIa trial of the CDK4/6 inhibitor palbociclib in patients with tumours with amplified D‐type cyclins or CDK4 or inactivation of CDKN2A.

Lucile Sebastian
Lucile Sebastian
Medical Oncology

MoST Substudy 2-5: Durva plus Treme

Molecular Screening and Therapeutics (MoST) Program Substudies 2 – 5: Single arm, open label, signal seeking, phase IIa trial of the activity of Durvalumab (MEDI4736) in combination with Tremelimumab in patients with advanced rare or neglected cancers

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

MVT-601-3201

A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men with Advanced Prostate Cancer

Prof Richard Epstein
Chloe Martin
Medical Oncology

My Medic Watch

An Observational Single Blind Study of a Smartwatch App for the Detection of Falls in an at-risk population.

Professor Bruce Brew
Josh
Neurology

NABNEC

A Randomised Phase II Study Of nab-paclitaxel In Combination with Carboplatin as First Line Treatment of Gastrointestinal Neuroendocrine Carcinomas

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

Neo Trio

A Phase II, Randomised, Open Label Study of Neoadjuvant Dabrafenib, Trametinib and / or Pembrolizumab in BRAF V600 Mutant Resectable Stage IIIB/C Melanoma

Louise Emmett
Sandie Grierson
Nuclear Medicine

Nohla Study

Eastern Seaboard Application - A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia

Prof David Ma
Chloe Martin
Haematology

NVX-108-GBM1B

NVX-108-GBM1B: A phase 1b/2 dose-finding, pharmacokinetic and pharmacodynamic study of NVX-108 combined with radiation and temozolomide in patients with newly-diagnosed glioblastoma multiforme

Dr Chelsie O'Connor
Chloe Martin
Radiation Oncology

ODM-201 in addition to standard androgen deprivation therapy (ADT) and docetaxel in metastatic hormone-sensitive prostate cancer Acronym: ARASENS

A randomized, double–blind, placebo–controlled Phase III study of ODM–201 versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone–sensitive prostate cancer.

Prof Richard Epstein
Chloe Martin
Medical Oncology

Onconova 04-30

A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physicians Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

Prof David Ma
Chloe Martin
Haematology

Online and Phone Assistance for Lung-cancer (OPAL)

A randomised controlled trial of online versus telephone-based information and support: Can electronic platforms deliver effective care for lung cancer patients?

Dr Emily Stone
Chloe Martin
Thoracic / Lung

ONTRANS

The Effect of Oral Nicotinamide on Non-Melanoma Skin Cancer Incidence and Actinic Keratoses in Renal, Hepatic, Heart and Lung Transplant Recipients: A Randomised Controlled Trial

Vanessa Paddon
Vanessa Paddon
Dermatology

OPAL

The first placebo controlled trial of opioid analgesia for acute spinal pain

Prof Richard Day
Prof Richard Day
Pharmacology

Oscillate

Phase 2 trial of alternating osimertinib with gefitinib in patients with EGFR-T790M mutation positive advanced non-small cell lung cancer.

Dr Rachel Dear
Chloe Martin
Medical Oncology

OXYGEN-HF

Oxygen to relieve dyspnoea in non-hypoxaemic patients with end-stage heart failure

Prof Peter Macdonald
Christine Hwang
Cardiology

OZI 202

A Long Term Follow-up Protocol to evaluate the safety and survival of autologous CD34+ hematopoietic progenitor cells transduced with an anti-HIV-1 ribozyme (OZ1) in patients with HIV-1 infection

Prof. Andrew Carr
Florence Bascome, Fiona Peet
Immunology

PanCO

An open label, single arm pilot study of OncoSil™, administered to study participants with unresectable locally advanced pancreatic adenocarcinoma, given in combination with FOLFIRINOX or gemcitabine+nab-paclitaxel chemotherapies.

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

PATINA (AFT–38 / ANZ 1701)

A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

A/Prof Elgen Lim
Chloe Martin
Medical Oncology

PAX-1

A Randomised, Double-Blind, Parallel-Group, Placebo Controlled Phase II Study to Assess the Clinical Benefit of 3 Doses of PAX-1 as Adjunctive Treatment for Persistent Cancer Pain

Prof Richard Chye
Penny West
Palliative Care

PCI32765DBL3001 (Phoenix) CRGH

A Randomised, Double blind, Placebo controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (RCHOP) in Subjects with Newly Diagnosed NonGerminal Center BCell Subtype of Diffuse Large BCell Lymphoma

A/Prof John Moore
Chloe Martin
Medical Oncology

PCI-32765LYM1002

A Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the Combination of Ibrutinib with Nivolumab in Subjects with Haematologic Malignancies

Prof David Ma
Chloe Martin
Haematology

PCYC-1140-IM

A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination with Corticosteroids versus Placebo in Combination with Corticosteroids in Subjects with New Onset Chronic Graft Versus Host Disease (cGVHD).

A/Prof John Moore
Chloe Martin
Haematology

Perinatal 'MUMentum' Program

A randomised controlled trial comparing the clinical efficacy of internet-delivered cognitive behavioural therapy for perinatal anxiety and depression to treatment as usual: Perinatal 'MUMentum' Program

Dr Alison Mahoney
Siobhan Loughnan
Anxiety/CRUFAD

PHAEDRA

Unable to find file on Common Drive or Hardcopy file.

Prof. Anthony Kelleher
Florence Bascombe
Immunology

Phase I Study of MK-3475 in Combination with Trametinib and Dabrafenib

A Phase I/II Study to Assess the Safety and Efficacy of MK-3475 in Combination with Trametinib and Dabrafenib in Subjects with Advanced Melanoma

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

Phase III RCT of melatonin for prevention of delirium in cancer

Randomised double-blind placebo-controlled phase III trial of oral melatonin for the prevention of delirium in hospital in people with advanced cancer

Prof Richard Chye
Penny West
Palliative Care

PILLAR : TMC435-TiDP16

A Phase IIb, randomised, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including PegIFN alfa-2a & Ribavirin in treatment naive genotype 1 Chronic Hepatitis C infected subjects.

Prof Gregory Dore
Richard Norris
Viral Hepatitis

POH035-13

A Randomized, Double-Blind, Placebo Controlled, Crossover, Phase IIa Study Comparing a Single Application TPM®/Oxycodone Patch versus Vehicle Patch in the Topical Treatment of Patients with Postherpetic Neuralgia (POH035-13).

A/Prof Steven Faux
Florence Bascombe
Rehabilitation

Polymer-Free DES Trial

A Clinical Evaluation of the Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

Prof David Muller
Erika O'Dea
Cardiology

Post-Operative Skin Trial (POST Study)

Post-Operative Concurrent Chemo-Radiotherapy versus Post-Operative Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck

Dr David Dalley
Dale Dalley
Medical Oncology

PRELUDE

Implementation of HIV pre-exposure prophylaxis with antiretroviral medications among people at high risk for HIV infection: A demonstration project

Prof Andrew Carr
Robyn Richardson
Immunology

PReSS

A retrospective cohort study of the newly implemented Rehab PRESS screening service (whereby all hospital admissions are proactively screened for rehab needs 5-7 days after admission)

Dr Jane Wu
Dr Christine Shiner
Rehabilitation

PRIME-MIC-1

Identification of plasma biomarkers of therapeutic response in men with metastatic prostate cancer

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

Protocol 401

A Phase 1 Study of ES414 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

Protocol I7X-MC-LLCF

Effect of LY3202626 on Alzheimer’s Disease Progression as Measured by Cerebral 18F-AV-1451 Tau-PET in Mild Alzheimer’s Disease Dementia.

Professor Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

Protocol TDE-PH - 310

A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

Prof Anne Keogh
Peta Brydon
Cardiopulmonary Transplant

Protocol TDE-PH - 311

An Open-Label Extension Study of UT-15C in Subjects with Pulmonary Arterial Hypertension - A Long-Term Follow-Up to Protocol TDE-PH-310.

Prof Anne Keogh
Peta Brydon
Cardiopulmonary Transplant

Proton Pump Inhibitors vs. Histamine-2 Receptor Blockers for Ulcer Pro

A multi-centre, cluster randomised, crossover, registry trial comparing the safety and efficacy of proton pump inhibitors with histamine-2 receptor blockers for ulcer prophylaxis in intensive care patients requiring invasive mechanical intervention

Priya Nair
Karlee Elissa McCann
Intensive Care

PULS

Prevalence of post-stroke upper limb spasticity and associated problems in nursing home residents; a cross-sectional study

Dr Yuriko Watanabe
Angela Vratsistas-Curto and Dr Christine Shiner
Rehabilitation

QUALITY

QUAlity of adherence to guideline recommendations for Life-saving treatment in heart failure: an international survey.

N/A
Carmen Herrera
Heart Failure

Quality of recovery after propofol vs sevoflurane anaesthesia: A randomised study in lumbar spinal surgery patients

Samuel Boyers
Samuel Boyers
Anaesthetics

RADICAL - RADiotherapy or Imiquimod in Complex lentigo mALigna

A randomised controlled multicentre trial of imiquimod versus radiotherapy for lentigo maligna (LM) when staged surgical excision with 5mm margins is not possible, is refused, or fails (ANZMTG 02.12)

Dr Gerald Fogarty
Chloe Martin
Radiation Oncology

RAD-TAC

Everolimus for the prevention of CNI-induced left ventricular hypertrophy in heart transplantation.

N/A
Carmen Herrera
Post Transplantation

Rapid HIV testing evaluation framework

John McAllister
John McAllister
Immunology

REACH-C

Real world Efficacy of Antiviral therapy in Chronic Hepatitis C.

Professor Greg Dore
Fiona Peet / Alison Sevehon
Viral Hepatitis

REACT

A randomised study of interferon-free treatment for recently acquired hepatitis C in people who inject drugs and people with HIV Coinfection.

Professor Greg Dore
Fiona Peet / Alison Sevehon
Viral Hepatitis

Reboot Online

Reboot Online: A pilot trial and randomised controlled trial of an online treatment program for chronic pain

Prof Gavin Adrews
Jessica Smith
Anxiety/CRUFAD

REDUCE LAP-HF RANDOMIZED TRIAL II

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure

Prof Christopher Hayward
Clare Coates
Cardiology

REDUCE LAP-HFREF Trial

A study to evaluate the Corvia Medical, Inc. IASD System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure with Reduced Ejection Fraction.

Prof David Muller
Erika O'Dea
Cardiology

Reducing the impact of aphasia in stroke patients and their caregivers

Reducing the impact of aphasia in stroke patients and their caregivers a year post onset via a brief early intervention: a cluster randomised control trial of the Action Success Knowledge (ASK) program.

A/Prof Steven Faux
Maria Berarducci
Rehabilitation

RESPECT-ESUS

Randomized,doubleblind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate (110mg or 150mg, oral b.d) versus acetylsalicylic acid (100mg oral q.d) in patients with Embolic Stroke of Undetermined Source

A/Prof Romesh Markus
Kirsty Page
Neurology

RESTORE II Trial

Safety and Performance Study of the ReZolve2 Sirolimus-Eluting Bioresorbable Coronary Scaffold. A prospective, multi-centre, Safety and Performance study.

Prof David Muller
Ashley Douglas
Cardiology

ROCHE AD

A PHASE III, Multicentre , randomized, Double Blind, Placebo-controlled, parallel-group, Efficacy and Safety study of Crenezumab in patients with prodromal to mild Alzheimers Disease.

Professor Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

ROCHE CREAD 2 OL

A multicentre, open-label, long-term extension of phase iii studies (bn29552/bn29553) of crenezumab in patients with Alzheimer’s disease

Prof. Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

ROCHE GRADUATE

A phase III, multicentre, randomized, Double-blind, placebo-controlled, Parallel-group, efficacy, and safety study of gantenerumab in patients with Prodromal to mild Alzheimer’s disease

Prof. Bruce Brew
Marko Garcia
Neurology / Alzheimer’s Disease

ROTEM algorithm for ECMO bleeding

A randomized controlled trial of the safety and feasibility of a rotational thromboelastometry (ROTEM) based algorithm to treat bleeding episodes in extracorporeal membrane oxygenation (ECMO)

Priya Nair
Priya Nair
Intensive Care

Safety of metformin in liver disease

The pharmacokinetics and safety of metformin in patients with liver disease

Prof Richard Day
Shaun Kumar
Pharmacology

SEARCH- C

SurvEillance for Antiviral Resistant variants in Chronic Hepatitis C patients.

Dr Gail Mathews
Rebecca Hickey
Viral Hepatitis

Sedation Practice in Intensive Care Evaluation: A Randomised Controlled Trial (SPICE RCT)

NSW Sedation Practice in Intensive Care Evaluation: A Prospective Multicentre Randomised Controlled Trial of Early Goal Directed Sedation Compared to Standard Care in Mechanically Ventilated Critically Ill Patients

Suhel Al-Soufi
Suhel Al-Soufi
Intensive Care

Sexual quality of life of people with HIV and/or Hepatitis C in Australia: A qualitative insight and the development of a sexual life questionnaire

John McAllister
Ben Huntingdon
Immunology

SHERLOC - MM-121-01-02-09

A Phase 2 Study of MM-121 in Combination with Docetaxel versus Docetaxel alone in Patients with Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Dr Rachel Dear
Chloe Martin
Medical Oncology

Simplify

A phase II, open-label, single arm, multicentre, international trial of sofosbuvir and GS-5816 for people with chronic hepatitis C virus infection and recent injection drug use.

A/Prof Gail Matthews
Fiona Kilkenny
Viral Hepatitis

Smart Glasses pII

E-hab activity recording – trialling the second Smart Glasses prototype device

A/Prof Steven Faux
Dr Christine Shiner
Rehabilitation

Smart Glasses prototype II

E-hab activity recording in rehabilitation - trialling the second Smart Glasses prototype device

A/Prof Steven Faux
Dr Christine Shiner
Rehabilitation

SMART-C

A phase IIIb, open-label, multicentre, international randomised controlled trial of simplified treatment monitoring for 8 weeks glecaprevir (300mg)/pibrentasvir (120mg) in chronic HCV treatment naïve patients without cirrhosis.

Professor Greg Dore
Fiona Peet / Alison Sevehon
Viral Hepatitis

SMOC+2017

A surveillance study in multi-organ cancer prone syndromes

Prof David Thomas
Chloe Martin
Medical Oncology

SOCRATES PRESERVED

Phase IIb safety and efficacy study of four dose regimens of BAY 1021189 in patients with worsening HF and preserved EF (SOCRATES PRESERVED)

Prof Anne Keogh
Annette Pidoux
Cardiopulmonary Transplant

SODIUM HF

The long term effects of dietary sodium restriction on clinical outcomes in patients with heart failure.

N/A
Carmen Herrera
Heart Failure

SOMAD

Somatic Mutations in Autoimmune Disease

Prof. Andrew Carr
Florence Bascombe
Immunology

SPACE

Study of Pomalidomide in anal cancer precursors – A Phase 2 study of immunomodulation in people with persistent HPV-associated high grade squamous intraepithelial lesions - Kirby.

Dr Mark Polizzotto
Simon Comben
HIV Oncology Studies

SPANC

A study of the natural history of anal human papillomavirus infection and anal cellular abnormalities in homosexual men.

Dr Richard Hillman
Daniel Seeds / Simon Comben
Anal Cancer/HIV

SPARTAN

A Multi-centre, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Prof Richard Epstein
Lynne Jolly
Medical Oncology

SPARTA-OLE (GTil201-OLE)

An Open-Label, Multicenter Study to Evaluate the Longterm Safety of Weekly Intravenous Alphal-Proteinase Inhibitor (Human), Modified Process 60 mg/kg in Subjects With Pulmonary Emphysema Due to Alphal-Antitrypsin Deficiency

Prof Allan Glancille
Lisa Singleton
Cardiopulmonary Transplant

Starplus B in FAP (major trial) NSW

The effects of butyrylated high amylose maize starch on polyposis in familial adenomatous polyposis patients

Prof Allan Spigelman
Yen Peng Lim
Medical Oncology

STARRT-AKI (NSW)

Standard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomised, Controlled Trial

Dr Hergen Buscher
Claire Reynolds
Intensive Care

START

Strategic Timing of AntiRetroviral Treatment

Prof Anthony Kelleher
Florence Bascombe
Immunology

Statin VS Switch

Rosuvastatin versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults

Prof. Andrew Carr
Frederick Lee
Immunology

Statins in Metastatic CRPC

Statins in Metastatic Castration-Resistant Prostate Cancer

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

STELLAR 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis.

Dr Mark Danta
Fiona Peet / Alison Sevehon
Viral Hepatitis

STOP

Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.

Dr Gail Mathews
Alison Sevehon
Viral Hepatitis

STop Or REtain - STORE

Impact of stopping sulfonylureas in patients with premix insulin

Dr Alexander Viardot
Dr Alexander Viardot
Endocrinology

STOP-AUST

The Spot sign and Tranexamic acid On Preventing ICH growth - AUStralasia Trial

A/Prof Romesh Markus
Natalie Wilson
Neurology

Stroke Imaging and machine-learning

Extracting novel insights from clinically acquired neuroimaging data to explore impairment and recovery post-stroke: investigating a new analytical pathway via machine-learning

Dr Christine Shiner
Rehabilitation

Study to compare a dolutegravir-based two-drug HIV regimen with a standard dolutegravir-based three-drug regimen

A Phase III, randomised, double-blind, multicentre, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected treatment-naive adults

Prof Anthony Kelleher
Fiona Kilkenny
Immunology

SVH Australasian Resuscitation In Sepsis Evaluation (ARISE)

A multi-centre randomised controlled trial of early goal-directed therapy in patients presenting to the Emergency Department with severe sepsis in Australasia

Priya Nair
Claire Reynolds
Intensive Care

SVH Interim-PET/CT-directed Therapy in DLBCL

Early Treatment Intensification with R-ICE Chemotherapy Followed by Autologus Stem Cell Transplantation Using Z-BEAM for Patients with Poor Prognosis Diffuse Large B-Cell Lymphoma as Identified by Interim PET/CT Scan Performed After Four Cycles of R-CHOP-14 Chemotherapy

Dr Samuel Milliken
Chloe Martin
Haematology

Tacrolimus Target AUC Study in Lung Transplantation

David Darley
David Darley
Thoracic / Lung

TAME Cardiac Arrest Trial

Targeted therapeutic mild hypercapnia after resuscitated cardiac arrest: A phase III multicentre randomised controlled trial

Dr Hergen Buscher
Claire Reynolds
Intensive Care

TARGET3D

An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin for people with recently acquired hepatitis C virus infection with or without HIV co-infection

Dr Gail Matthews
Rebecca Hickey
Viral Hepatitis

Telerehabilitation for Trauma (TReT)

Investigating the feasibility of a novel telehealth intervention to provide rehabilitation services for patients following trauma.

Dr Steven Faux
Chrisitine Shiner
Rehabilitation

Tendyne

Expanded Clinical Study of the Tendyne Mitral Valve System

Prof David Muller
Erika O'Dea
Cardiology

Test

The "Deckled" Incision - A New Approach to Improving Postoperative Scars

Dr Elias Moisidis
Dr Elias Moisidis
Plastic Surgery

The ASSURE study

A Phase II dose escalation study of cyclophosphamide in haematopoietic stem cell transplantation in severe systemic sclerosis patients unfit for standard dose cyclophosphamide.

A/Prof John Moore
Chloe Martin
Haematology

The Attain Study

A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated with an Anthracycline, a Taxane, and Capecitabine

A/Prof Elgene Lim
Chloe Martin
Medical Oncology

the BALANCE study

Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: Randomized Controlled Trial

Dr Samual Rudham
Claire Reynolds
Intensive Care

The BEACON CRC Study

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E-mutant Metastatic Colorectal Cancer

Dr Lorraine Chantrill
Chloe Martin
Medical Oncology

The COPS Trial

Colchicine in Patients with Acute Coronary Syndromes

Prof David Muller
Dr Roberto Spina
Cardiology

The CREDENCE Trial

AR_A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy

Dr Kiernan Hughes
Lynn Schofield
Endocrinology

The effect of silicone vs. non-silicone dressings on postoperative scar: a randomized controlled study

James Southwell-Keely
Ines Prasidha
Plastic Surgery

The effect of weekly rifapentine and isoniazid, compared to 9 months of isoniazid, upon adherence with treatment for latent TB infection in Sydney Local Heath District

Anthony Byrne
Dr Greg Fox
Thoracic / Lung

The Efficacy of Levodopa treatment in Adult Onset Primary Dystonia Patients

A prospective, randomized, double blind, placebo-controlled, crossover study of the effectiveness of Levodopa treatment in Adult Primary Dystonia Patients.

Dr Stephen Tisch
Fiona Kilkenny
Neurology

The International LDCT Study

Prospective Evaluation of Selection Criteria for Lung Cancer Screening With Low-dose Thoracic Computed Tomography and Standardized System for Nodule Management - An International Study

Dr Emily Stone
Chloe Martin
Thoracic / Lung

The Lisdex Study

Dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence

A/Prof Nadine Ezard
A/Prof Nadine Ezard
Drug and Alcohol

The Online Mindfulness-Enhanced Program for Anxiety and Depression

The Online Mindfulness-Enhanced iCBT Program for Anxiety and Depression: A Pilot Trial and a Randomised Controlled Trial

Prof Gavin Andrews
Jill Newby
Anxiety/CRUFAD

The pharmacokinetics of probe drugs in patients with acute kidney injury

Dr Darren Roberts
Dr Sophie Stocker
Pharmacology

The PTSD Program

The PTSD Program - A Randomised Controlled Trial

Prof Gavin Andrews
Jessica Smith
Anxiety/CRUFAD

The SPHInX Study

A Multi-Centre Double-Blind Randomised Placebo-Controlled Trial of Oral Anticoagulation with Apixaban in Systemic Sclerosis-Related Pulmonary Arterial Hypertension.

Prof Anne Keogh
Karen Brown
Cardiology

The Sweet Spot: five levels of support for an anxiety and depression course plus usual care, compared to usual care alone

A randomised controlled trial comparing five levels of support for an anxiety and depression course plus usual care, to usual care alone.

Prof Gavin Andrews
Prof Gavin Andrews
Anxiety/CRUFAD

The TARGET Nutrition Study (Amended)

The Augmented versus Routine approach to Giving Energy Trial : A randomised controlled trial

Dr Manivannan Gopalakrishnan
Claire Reynolds
Intensive Care

TRANSFUSE

STandaRd Issue TrANsfusion versuS Fresher red blood cell Use in intenSive carE (TRANSFUSE) - a randomised controlled trial

Dr Mark Nicholls
Serena Knowles
Intensive Care

Transplant rehabilitation audit

A retrospective audit of inpatient rehabilitation following transplantation at St Vincent’s Hospital and Sacred Heart Health

A/Prof Steven Faux
Dr Christine Shiner
Rehabilitation

TREATT: Trial to EvaluAte Tranexamic acid therapy in Thrombocytopenia

A double blind, randomised controlled trial evaluating the safety and efficacy of Tranexamic acid in patients with haematological malignancies with severe thrombocytopenia.

Dr Joanne Joseph
Chloe Martin
Haematology

TRESAX

Contribution of T follicular helper cells to maintenance of and recrudescence of virus from the latent HIV-1 reservoir

Prof. Anthony Kelleher
Florence Bascombe
HIV

TRITON

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension, a multicenter, double-blind, placebo controlled Phase 3b study.

Prof Anne Keogh
Annette Pidoux
Cardiopulmonary Transplant

TTP

Translational neurorehabilitation - a telehealth transfer package to integrate evidence-based research into routine clinical practice post-stroke.

Dr Steven Faux
Dr Angelica Butel
Rehabilitation

ULIS-III

An international, multicentre, observational, prospective, longitudinal cohort study to assess the impact of integrated upper-limb spasticity management including the use of Bont-A injections on patient-centred goal attainment in real life practice - ULIS III

A/Prof Steven Faux
Dr Christine Shiner
Rehabilitation

UNISoN: anzUp Nivo plus Ipi+nivo Sequential Non-clear cell

Phase II Sequential Treatment Trial Of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab In Metastatic Or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602).

A/Prof Anthony Joshua
Chloe Martin
Medical Oncology

Use of TCZ to prevent acute GVHD in HLA-matched patients - randomized Phase III multicentre

A phase III randomized study of humanized anti-IL-6 receptor antibody Tocilizumab (TCZ) to prevent development of acute graft versus host disease (GVHD) post HLA-matched allogeneic haematopoietic progenitor cell transplantation (HPCT).

A/Prof John Moore
Chloe Martin
Haematology

VERICI

Single site, pilot RCT of early in-reach rehabilitation for survivors of critical illness

Dr Jane Wu
Angela Vratsistas-Curto and Dr Christine Shiner
Rehabilitation

Vitamin D dosing in SIRS

Vitamin D dosing study in Intensive Care Unit (ICU) patients with the Systemic Inflammatory Response Syndrome (SIRS)

Priya Nair
Priya Nair
Intensive Care

Wallaman GS-US312-0123

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combinationwith Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia

Dr Keith Fay
Robert Kent
Haematology

WAVECREST 2 Trial

WAveCrest Vs. Watchman TranssEptal LAA CLosure to REduce AF-Mediated STroke 2

Prof David Muller
Erika O'Dea
Cardiology

Whole Brain Radiotherapy following local treatment of intracranial metastases of melanoma - a randomised phase III trial

Dr Gerald Fogarty
Dale Dalley
Radiation Oncology

WORKING 2GETHER

Proactive in-reach rehabilitation service for all admitted patients with developmental/intellectual disability – a feasibility study of a new shared care model

Dr Jane Wu
Dr Christine Shiner
Rehabilitation

XanADu

A Phase II, Double-Blind, 12-Week, Randomised, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects with Mild Dementia due to Alzheimer’s Disease (AD).

Professor Bruce Brew
Marko Garcia
Neurology

XL184–308 Cabozantinib

A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy

Prof Richard Epstein
Lalith Ratnayake
Medical Oncology

Young people and diabetes

Tools for resilience: A mobile phone and web-based intervention for improving mental wellbeing and reducing distress in adolescents and young adults with Type 1 diabetes

Prof Lesley Campbell
Janine Clarke
Endocrinology

Zoledronate Versus Tenofovir Switching for Low BMD - ZEST

Bisphosphonate Therapy with Zoledronate or Tenofovir Switching to Improve Low Bone Mineral Density in HIV-Infected Adults: a Strategic, Randomised Trial

Prof Andrew Carr
Robyn Richardson
Immunology