Clinical Trials | A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)

The UVA Comprehensive Cancer Center seeks adults ages 18 and over Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy. The purpose of this study is to test if the investigational drug IDRX-42 can improve your GIST when compared to the approved drug sunitinib. IDRX-42 is considered investigational because has not been approved by any authority that regulates new medications, including the United States Food and Drug Administration (FDA) or any other international regulatory/government agencies. Sunitinib is a medication approved in many countries and available by prescription to treat GIST. It is used when the cancer gets worse after treatment with imatinib or when patients cannot tolerate imatinib. This study aims to test if IDRX-42 can improve your GIST, when compared to sunitinib. If you join this study, a computer will randomly assign you to receive either IDRX-42 or sunitinib. This is called randomization. Neither you nor your study doctor can choose the drug, but both of you will know which one you’re given. The study involves receiving the study drugs, as well as coming in for study visits, which include exams, laboratory tests, imaging scans, procedures such as having your blood drawn, and talking to the study doctor. If you choose to participate the study will consist of three periods: screening, study treatment, and follow-up. The screening period is where the study team will see if you are eligible for the study. After screening, if you are deemed eligible for participation, you will enter the treatment period where you will receive the study drugs and participate in study visits. The treatment period is divided into “cycles”. A single cycle in this study is equal to 6 weeks (42 days). After screening, you will come to the clinic for a total of 3 visits in Cycle 1 and 2 visits in Cycle 2. After Cycle 2 you will come to the clinic once every 6 weeks until the last dose of study drug. You may continue taking study drug (IDRX-42 or sunitinib) as long as your study doctor believes there is no worsening of your disease, and you do not have serious side effects. After completing the treatment period, you will be asked to return to the clinic within 14 days for an End of Treatment visit. You will then be contacted via telephone every 3 months to check how you are doing. Depending on when you join the study, your participation may last up to approximately 60 months, including the follow-up period. The study drug, IDRX-42 or sunitinib, will be provided by the sponsor at no cost to you. All additional study procedures that are beyond your standard medical care, including laboratory tests, physical examinations, and visits to the study center, are provided to you at no charge. Additional information can be found here: https://clinicaltrials.gov/study/NCT05489237 [email protected]