Your health will be monitored continuously throughout StrateGIST 3 Trial. Even if you do not directly benefit from participating in the trial, any information collected may help researchers learn more about the study drug IDRX-42 and about treating other adults with GIST in the future.

As with all medicines, there is a risk for side-effects from the study drugs. However, your safety is our top priority. Your health will be closely monitored during the entire study. A special group of experts called the Data Monitoring Committee will also review data throughout the entire trial to ensure that all participants are kept safe.

The study treatment, site visits and study-related tests will be paid for by the clinical trial sponsor, IDRx, Inc. and will not cost you anything. You will be reimbursed for reasonable study visit-related travel expenses.

Participation in a clinical trial is voluntary. If you decide to join and then change your mind, you can leave the trial at any time. Leaving the trial will not affect your regular medical care.

GIST is frequently caused by changes, or mutations, in a gene for a normal cell protein called KIT. These mutations lead to over-activation of KIT – like a switch stuck in the on position – causing cancer cells to multiply.

IDRX-42 is a tyrosine kinase inhibitor (TKI). TKIs stop or slow down KIT activity and the resulting growth of cancer cells. Other TKIs are used for GIST but may not work against all KIT mutations. IDRX-42 is designed to cover a broader range of KIT mutations.

As with all medicines, there is the possibility of side-effects, which are unwanted or unintended effects of a medicine. Talk to the study doctor for more information on possible side-effects. Your health will be closely monitored throughout the entire trial. Tell the study doctor if you notice any side-effects or changes in your health.

Yes, the study doctor will let you know which study treatment you are receiving.

If I am assigned to receive sunitinib, will I have a chance of receiving IDRX-42? If you are taking sunitinib and your cancer worsens, you may be able to change to IDRX-42.

You will be in the trial for up to 5.5 years. As with any clinical trial, you may stop participation at any time for any reason or no reason. IDRX, Inc. does not have any plans to provide IDRX-42 or any other study drugs or procedures to you after the end of the trial or if you have discontinued or have been withdrawn from the trial.

If you qualify for the trial, you will be randomly placed into a group to receive either IDRX-42 or sunitinib, a treatment approved in some countries for the type of GIST being studied.

IDRX-42 comes as tablets that you will take by mouth with water (with or without food). You will take IDRX-42 once a day as directed by the study doctor. You will keep taking IDRX-42 for as long as your cancer is not getting worse and you are tolerating treatment.

Sunitinib comes as capsules that you will take by mouth with water (with or without food). Sunitinib is taken once a day for 28 days at a time, followed by a 14-day break, unless otherwise instructed. You will keep taking sunitinib for as long as your cancer is not getting worse and you are tolerating treatment. If your cancer worsens while taking sunitinib, you may be able to change to IDRX-42.