Click here to watch a video about StrateGIST 3, including the purpose of the study, who can join the study, the study drugs, and what to expect during the study.
Click here to watch a video about StrateGIST 3, including the purpose of the study, who can join the study, the study drugs, and what to expect during the study.
What is StrateGIST 3?
StrateGIST 3 is a clinical trial testing an investigational drug (study drug) called IDRX-42 (GSK6042981) in adults with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) who have progressed on or were intolerant to first-line therapy with imatinib. Researchers want to learn more about the safety IDRX-42 (GSK6042981) and compare its effects with sunitinib, which is a treatment approved in some countries for the type of GIST being studied. This trial will build upon learnings about IDRX-42 (GSK6042981) from an earlier trial in people living with GIST.
The video below provides an overview of StrateGIST 3, including the purpose of the study, who can join the study, the study drugs, and what to expect during the study.
Informed Consent
Before you decide whether you want to participate, the study team will review the details of the trial with you. This includes possible risks and benefits and what you can expect if you joined. If you decide to participate, you will be asked to sign an Informed Consent Form. This confirms that you understand the trial and are willing to take part to determine if you are eligible.
Screening
To see if you qualify, you will have at least 1 visit to the study site to answer questions about your health and the medicines you take, and to have some tests.
Study Treatment
If you qualify for the trial, you will be placed by chance into a group to receive either IDRX-42 or sunitinib (the approved treatment).
IDRX-42 is provided as tablets that are taken by mouth once a day at home. IDRX-42 is taken every day. Sunitinib is taken for 28 days in a row, followed by a 14-day break (unless otherwise instructed by your doctor).
During the Study Treatment Period, you will come to the study site to check on your health and how your cancer is responding to the study treatment (IDRX-42 or sunitinib).
If you are taking sunitinib and your cancer worsens, you may be able to switch to IDRX-42.
The study treatment (IDRX-42 or sunitinib), visits, and study-related tests will be paid for by the clinical trial sponsor. Reimbursement will be available for study visit-related travel expenses.
Follow-up
Once you and your doctor decide to stop the study treatment, you will have 2 more visits and will have phone calls with the study team every 3 months.
What happens during the trial?
The trial will test the study drug, IDRX-42 (GSK6042981), in adults who have metastatic and/or unresectable GIST that has progressed while taking imatinib or who do not tolerate imatinib side effects. The goal is to compare the safety and effects of IDRX-42 (GSK6042981) versus sunitinib.
IDRX-42 (GSK6042981) is a study drug and has not been approved by any healthcare authority for use outside of a clinical trial.
Your StrateGIST 3 Journey
Interested in learning more?
Talk to your doctor for more information and click on the link below to find a StrateGIST 1 Trial site near you.
Participation in the trial is voluntary and you can choose to leave at any time.
Interested in learning more?
Talk to your doctor for more information about StrateGIST 3.
You may also click on a location on the map below to find a StrateGIST 3 site near you. StrateGIST 3 will be available in up to 150 clinical trial sites globally. New sites may be opening, so please check back for updates.
Study visit-related travel expenses may be reimbursed.
Informed Consent
(learn about the trial and agree to take part)
Screening
(see if you qualify)
Study Treatment
IDRX-42 or sunitinib
