Facilitating advances in medical care

The Clinical Trials Unit (CTU) based at the Gallipoli Medical Research Foundation consists of a team of specialist research nurses and scientists.

We provide our research partners with first-class conduct, management and coordination of multi-centre national and international clinical research trials.

Our aim is to deliver clinicians and patients with access to new and emerging medications in an effort to advance medical care for all.

Benefits of our clinical trials

These phase I-IV clinical trials benefit the community through enhanced medical knowledge about the place and value of new treatments. Medical specialists can gain experience with new therapies and trial participants can take part in study protocols of new and potentially improved therapies. The result is enhanced quality of care and treatment not available as standard care.

Information for the medical community: Conducting a trial with us

The CTU team manages all documentation of clinical trials including paper and computer based case record forms. We also assist with study design, regulatory affairs, database maintenance, and participant recruitment. The CTU takes responsibility for liaising between the Gallipoli Medical Research Institute, the Therapeutic Goods Administration (TGA) and local ethics committees.

Future plans for the unit include increasing our capacity to assist more clinical researchers with the management of clinical trials.  Our dedicated CTU facilities are based on the campus of Greenslopes Private Hospital and we can support any investigator accredited to consult at the hospital. In addition, our staff develop successful partnerships with pharmaceutical companies and research organisations – large and small.

We provide our research partners with first-class conduct, management and coordination of multi-centre national and international clinical research trials. Our aim is to deliver clinicians and patients with access to new and emerging medications in an effort to advance medical care for all.

If you would like to conduct a clinical trial under the auspices of the CTU, please contact Dr Suzanne Elliott (Gallipoli Medical Research Foundation Clinical Trial Manager) on 07 3394 7284.

Information for prospective trial participants

All CTU trials are run under strict conditions. Our Clinical Trial Coordinators ensure that you are treated with the utmost care, while our Data Manager oversees the meticulous data entry for each of your participant visits. In addition, trial monitors from each company involved in our trials visit us regularly and double check every single number that we enter in order to ensure the trial is run correctly.

You will never be ‘out of pocket’ health wise for participating in a trial; every patient gets the standard of care treatment – alone or combined with a new treatment. Our job is to work with you to make sure that any new treatments truly live up to their claims. By doing that, we can together improve future health outcomes for all Australians and the wider global community.

Please visit the pages of our website which list the studies which are currently open for recruitment to see if there is a trial in which you are interested in taking part. You may also wish to complete this form if you would like to be notified of future clinical trials which might be of interest to you.

Studies open for recruitment

Liver Studies

1. Protocol: 747-303.
Short Title: The REGENERATE Study.

Protocol Title: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis.

Lay Title: Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)

2. Protocol: LJ401-HH01

Protocol Title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study with LJPC-401 for the Treatment of Iron Overload in Adult Patients with Hereditary Hemochromatosis

Lay Title: A Study of LJPC-401 for the Treatment of Iron Overload in Adult Patients With Hereditary Hemochromatosis

Click here for more information

3. Protocol: 747-304.
Short Title: The REVERSE Study.

Protocol Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Lay Title: Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE)

Click here for more information

Oncology Studies

1. Protocol: MK-3475-022. KEYNOTE-022

Protocol Title: 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.

Lay Title: A study to investigate MK-3475 (pembrolizamab) in combination with trametinib and dabrafenib in patients with advanced melanoma.

2. Protocol: D081DC00007

Protocol Title: A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)

Lay Title: Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

3. Protocol: CO39721

Protocol Title: A Phase Ib Study Evaluating Cobimetinib Plus Atezolizumab in Patients With Advanced BRAF V600 Wild-Type Melanoma Who Have Progressed During or After Treatment With Anti−PD-1 Therapy

Lay Title: A Study Evaluating Cobimetinib (Targeted Therapy) Plus Atezolizumab (Immunotherapy) in Participants With Advanced Melanoma Whose Cancer Has Worsened During or After Treatment With Previous Immunotherapy

4. Protocol: Protocol: CA224-020 (PART D)

Protocol Title: A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced  Solid Tumors

Lay Title: The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. (Part D: melanoma that HAVE previously been treated with immunotherapy

5. Protocol: CK-101-101

Protocol Title: A Phase I/II, Open-Label, Safety, Pharmacokinetic and Efficacy Study of Ascending Doses of Oral CK-101 in Patients With Advanced Solid Tumors

Lay Title: This is a first-in-human, two-part, open-label, safety, pharmacokinetic, and efficacy study of oral CK-101 administered daily in ascending doses in patients with advanced solid tumor cancer, followed by a Phase 2 portion at the recommended Phase 2 dose (RP2D) in previously treated non-small cell lung cancer (NSCLC) patients who have documented evidence of EGFR T790M mutation and have failed treatment with a first-line EGFR inhibitor.

6. Protocol: INCAGN 1876-201

Protocol Title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Lay Title: A Clinical trial with the purpose to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

7. Protocol: 2125-MEL-301 (ILLUMINATE 301) (NCT03445533)

Protocol Title: A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma

Lay Title: A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

Click here for more information

8. Protocol: CA224-047

Protocol Title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined with Nivolumab versus Nivolumab in Participants with Previously Untreated Metastatic or Unresectable Melanoma

Lay Title: A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

Click here for more information

9. Protocol: I8X-MC-JECA (Part B & C)

Protocol Title: A Phase 1 Study of LY3200882 in Patients with Solid Tumors

Lay Title: A Phase 1 Study of LY3200882 in Patients with Solid Tumors

Click here for more information

Respiratory  Studies

1. Protocol: SAV008-01

Short Title: The OPTIMA Study:

Protocol Title: An Open-label, Non-controlled, Multicentre, Pilot Clinical Trial of Inhaled Molgramostim in Subjects With Antibiotic-resistant Non-tuberculosis Mycobacterial (NTM) Infection

Lay Title: Pilot Trial of Inhaled Molgramostim in Non-tuberculosis Mycobacterial (NTM) Infection (OPTIMA)

Click here for more information

2. Protocol: INS1007-201 (The WILLOW Study)

Protocol Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis – The Willow Study

Lay Title: Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis

Click here for more information

 

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