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Gallipoli
Medical Research Centre Clinical Trials Unit
Clinical
trials require the participation and assistance of volunteers. Without
volunteers the development and advancement of new medications cannot
happen.
There
are a number of benefits to volunteering for a clinical trial, including:
- Comprehensive medical care free
of charge
- Access to new treatments and medications
that may improve quality of life and that are currently unavailable
as standard of care
- Potential to help others with similar
conditions in the future.
Any
risks associated with participating in a clinical trial will be
explained prior to joining the trial and patients are able to withdraw
their consent at any time.
Patients
do not incur any costs when taking part in a clinical trial. All
treatment and tests are free if they are outside standard of care.
All
studies are approved by Greenslopes Private Hospital 's Ethics Committee.
Click
here to fill out a form so that you can be notified
of clinical trials that may be of interest to you. You
will be contacted by one of our clinical trials coordinators.
Current trials seeking volunteers
The Clinical Trials Unit is currently seeking volunteers for the following trials:
Cancer
- Colorectal Cancer
A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and Irinotecan for Patients with Metastatic Colorectal Cancer
This is a multicenter, double-blind, randomized, Phase II/III study of MK-0646 administered to patients with metastatic colorectal cancer who previously failed both oxaliplatin and irinotecan-based chemotherapies. These patients should have progressed upon completion of therapy with objective radiological evidence of progression. Patients will receive MK-0646 or placebo when receiving Cetuximab and Irinotecan.
- Melanoma
Adjuvant immunotherapy with anti-CTLA-4 monoclonal antibody (ipilimumab) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double-blind Phase III trial for the EORTC Melanoma Group.
The purpose of this study is to examine the safety and effectiveness of an investigational compound known as ipilimumab (also known as MDX-010). The efficacy of ipilimumab will be determined by looking at the ability of the drug to delay disease relapse after surgery.
A Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of Treatment with OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Previously Treated Melanoma Patients with Unresectable Stage IIIb, IIIc and IV Disease.
The objective of this study is to evaluate the efficacy and safety of treatment with OncoVEXGM-CSF compared to subcutaneously administered GM-CSF in previously treated melanoma patients with unresectable Stage IIIb, IIIc and Stage IV disease. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with OncoVEXGM-CSF as compared to GM-CSF.
- Myeloma
A phase II trial of PAD induction therapy in transplant-eligible patients with untreated multiple myeloma (MM), stratified for markers of bortezomib resistance. The PAD induction in Multiple Myeloma Stratified Trial (The PIMMS Trial).
This is a multicenter, Phase II, open label, single arm study of PAD in transplant eligible patients with previously untreated multiple myeloma. This study tests whether an experimental drug, bortezomib (Velcade®) in combination with doxorubicin and dexamethasone is safe and effective in people with untreated multiple myeloma. The purpose of this research study is to find out if amplification of chromosomal aberration in the 1q21 region respond to bortezomib treatment the same way that people without the change do.
- Leukaemia
A Phase II, Randomized, Open Label Study to Evaluate ECG Results and Pharmacokinetic Parameters for Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination with Lumiliximab Versus FCR Alone in Subjects with Previously Untreated Chronic Lymphocytic Leukaemia.
This study will provide the first data on the safety and effectiveness of FCR + lumiliximab versus FCR alone, in patients with previously untreated CLL. This study will hopefully lead to the implementation of an additional treatment for CLL in this patient population.
The purpose of this study is to evaluate:
(i) The safety of an experimental drug called lumiliximab in combination with fludarabine, cyclophosphamide and rituximab (FCR), including whether or not there are any effects on the normal electrical activity of the heart, and
(ii) To evaluate drug to drug interaction data concerning the effect of lumiliximab on the pharmacokinetics of fludarabine, cyclophosphamide, and rituximab, in patients with previously untreated chronic lymphocytic leukaemia (CLL).
Liver Disease
- Hepatitis C
An open-label, randomised, multicentre, active-controlled, dose-ranging sturdy to evaluate the safety and efficacy of albumin interferon alfa-2b administered every 4 weeks plus Ribavirin in interferon naïve patients with genotype 2/3 chronic hepatitis C.
This is a multicentre, Phase IIb, open label, dose-ranging study to evaluate the safety and tolerability of up to four doses of albumin interferon alfa-2b administered by subcutaneous injection every 4 weeks (900µg, 1200 µg, 1500 µg and possibly 1800 µg) plus Ribavirin (twice daily) in interferon naïve patients with genotype 2/3 chronic hepatitis C. The control arm will receive the standard of care: 180 µg Pegasys will be administered by subcutaneous injection weekly plus Ribavirin (twice daily). The results of this study will provide information on the dose(s) to be selected for future studies using the 4 weekly dosing schedule.
A Randomized, Double-blinded, Multicentre, Dose and Duration Finding Study to Evaluate the Sustained Virologic response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in combination with Pegasys® and Copegus® versus the currently approved combination of Pegasys® and Copegus® in treatment-naïve patients with chronic hepatitis C genotype 1 or 4 virus infection.
This phase 2, randomized, double-blinded, active controlled, parallel-group design study will have 4 experimental and 1 SOC treatment group and will be staggered over and within each of 2 cohorts. The study group hypothesise that the study will look at the effects of dose and duration of the HCV polymerase inhibitor prodrug (RO5024048) in combination with PEG-IFN and RBV versus the currently approved combination of PEG-IFN and RBV (SOC) in treatment-naive patients with chronic hepatitis C genotype 1 and 4 virus infection.
A Phase I, Placebo-Controlled, Randomized Study of the Safety, Pharmacokinetics and Antiviral Activity of BIT225 in Patients (Males and Females) with Hepatitis C Virus Infection. BIT225-003.
A randomized, parallel, double-blind study of BIT225 in patients with Hepatitis C virus infection that are treatment-naïve or non-responders to antiviral treatment with ribavirin and/or interferon alpha or treatment relapsers. Two dose levels of BIT225 (35 mg and 200 mg) and placebo will be studied with 6 patients per treatment group, resulting in 18 patients enrolled in total. Patients will receive study treatment once daily on Day 1 and Day 7 and twice daily on Days 2- 6.
- Liver Cancer
A phase II randomised, double-blind, placebo controlled study of sorafenib or placebo in combination with transarterial chemoembolisation (TACE) performed with DC bead and doxorubicin for intermediate stage hepatocellular carcinoma (HCC).
The purpose of this study is to assess if sorafenib in combination with TACE performed with DC beads and doxorubicin will slow down tumor progression and result in increased survival in patients with unresectable liver cancer.
Other
Phase III Twice-daily oral direct thrombin inhibitor dabigatran etexilate in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. (RE-SONATE)
The purpose of this study is to evaluate whether prolonged therapy with this new anticoagulant dabigatran etexilate after initial 6 to 18 months of standard treatment (Vitamin K Antagonist) is effective compared to placebo in the prevention of recurrent DVT or PE and that the likely advantage of an extended effect is not offset by an increase of bleeding complications.
Download
the Clinical Trials Unit information brochure
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