Monash Health, Clayton
A clinical trial of avapritinib versus regorafenib (Stivarga®) for people with advanced GIST that has progressed following first-line treatment with imatinib (Gleevec®) and one or two additional treatment regimens (third-line or fourth-line GIST).
The VOYAGER clinical trial will test an investigational drug called avapritinib, in people with advanced gastrointestinal stromal tumors (GIST), that has progressed following two or three prior treatment regimens. The main aim of the trial is to see how effective avapritinib is compared to an existing GIST treatment called regorafenib (Stivarga®).
Information about GIST
All cancers begin when one or more genes in a cell are mutated (altered) and the cell starts to divide and grow out of control. Identifying these genes is important because drugs can be developed to target them.
For example, we know that specific mutations (alterations) in the genes for KIT and PDGFRA are involved in the development of GIST. These genes provide the instructions for producing types of proteins called tyrosine kinase receptors that are involved in signaling cell growth and division. Avapritinib is an investigational drug that was specifically designed to inhibit (block) mutated forms of KIT and PDGFRA.
You may be eligible to take part in the VOYAGER clinical trial if you:
Have a gastrointestinal stromal tumor (GIST) that has progressed following first-line treatment with imatinib (Gleevec®) and one or two additional treatment regimens (third-line or fourth-line GIST)
Are not eligible for surgery for your GIST
Are at least 18 years old
Other eligibility criteria apply and these will be assessed at screening.
If you take part in the VOYAGER clinical trial, you would randomly receive either:
If you are assigned to the regorafenib (Stivarga®) group and your disease progresses, you will still have the opportunity to receive avapritinib.
Both study drugs come in tablet form and should be swallowed whole with water, as directed.
Up to 28 days
To assess your suitability for the trial.
All participants will receive the investigational drug, avapritinib, or the comparator drug, regorafenib (Stivarga®), for a minimum of 28 days (1 cycle). Avapritinib is dosed daily for 28 days; regorafenib (Stivarga®) is dosed daily for 21 days, with 7 days off.
All participants must have a follow-up visit at 14 days and 30 days after their last dose of study drug. Follow-up scans will be required periodically thereafter.
*There is no maximum duration for this trial. You will continue with your cycles of treatment until:
During the trial, a variety of health assessments will be conducted to see how you are responding to the investigational drug. In most cases, these assessments will be done at a clinical site.
Health assessments will vary between visits, but may include:
More information about health assessments and visit length will be found in the informed consent form, which you will need to read and sign if you want to take part in the VOYAGER clinical trial.
How often will these visits take place?*
Once per cycle
Cycle 4 onwards (e.g., cycle 5, 7, etc.)
Every odd cycle
*Please note that these numbers are approximate. One treatment cycle is 28 days.
Please enter your city, ZIP Code, or country to find a trial site near you, or see the full site list.
A travel support program is available for participants and caregivers at most trial sites to reduce out-of-pocket expenses and help ensure travel to the trial site is simple and comfortable. More information about travel support is provided by the trial site during the screening process.