What is StrateGIST 1?
StrateGIST 1 est une étude clinique évaluant un médicament expérimental (médicament à l’étude) appelé IDRX-42 chez des adultes atteints de tumeurs stromales gastro-intestinales (GIST) avancées qui n’ont pas été traitées ou ont progressé après traitement. L’IDRX-42 est un inhibiteur hautement sélectif et puissant de la protéine KIT, qui est hyperactive chez de nombreuses personnes atteintes de GIST, entraînant la croissance et l’accumulation des cellules cancéreuses. Les chercheurs veulent en savoir plus sur la sécurité d’emploi du médicament à l’étude, sur la façon dont il est toléré et sur les effets qu’il peut avoir sur les GIST.
What happens during the trial?
There are 2 parts (phases) to this trial: Phase 1 and Phase 1b. Phase 1 is complete. You would be participating in Phase 1b.
Phase 1b will test the study drug, IDRX-42, in adults who have not yet started treatment for GIST or whose GIST has progressed while taking other treatments. The goal of Phase 1b is to assess the safety of IDRX-42, how it is tolerated, and what effects it may have on GIST.
IDRX-42 is a study drug and has not been approved by any healthcare authority for use outside of a clinical trial.
Your participation in this trial will last for about 18 months.
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 you will have some tests.
Study Treatment
Everyone who qualifies for the trial and participates will receive the study drug, IDRX-42. The study drug is provided as tablets that you will take by mouth at home. You will take the study drug once a day.
During the Study Treatment Period, you will come to the study site to check on your health and how you are responding to the study drug.
The study drug, 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 stop taking IDRX-42, you will come to the study site for 2 more visits and will have phone calls with the trial team every 3 months for up to 1 year.
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 1.
You may also click on a location on the map below to find a StrateGIST 1 site near you. New sites will be opening, so please check back for updates.
Study visit-related travel expenses will be reimbursed.
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 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.