Leuven Cancer Institute University Hospitals Leuven, Leuven
Consider NAVIGATOR - a clinical trial of avapritinib for people with advanced GIST. This trial is currently enrolling patients who have progressed following first-line treatment with imatinib (Gleevec®).
The NAVIGATOR clinical trial will test an investigational drug called avapritinib in people with advanced GIST. The trial is currently enrolling patients who have progressed following treatment with imatinib (Gleevec®). It is a phase 1 trial designed to test the safety and initial clinical activity of avapritinib.
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 able to take part in NAVIGATOR clinical trial if you:
Group 1: Have progressed following first-line treatment with imatinib and at least 1 additional tyrosine kinase inhibitor (third-line or later)
Please note that Group 1 is fully enrolled and is no longer accepting new participants.
Group 2: Have a confirmed D842V mutation in the PDGFRα gene*
Please note that Group 2 is fully enrolled and is no longer accepting new participants.
Group 3: Have progressed following first-line treatment with imatinib
If you take part in the NAVIGATOR clinical trial, you will receive the investigational drug avapritinib. Avapritinib comes in a tablet form, and should be swallowed whole with water, once a day.
Up to 8 weeks (from start of screening to first dose)
To assess your suitability for the trial.
All participants will receive the investigational drug for a minimum of 28 days (1 cycle).
Follow up period
All participants must have a follow-up visit 14 days after their last dose of investigational drug. At 30 days, we will give participants a follow-up call and then again every 3 months until disease progression.
*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 NAVIGATOR clinical trial.
How often will these visits take place?*
Once per cycle
Cycle 3 onwards
Once per cycle
*Please note these numbers are approximations and apply only to Group 3 patients who have progressed on imatinib. 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.