What is the Purpose of this Study?
The purpose of this study is to determine the safety and effectiveness of an experimental drug called IDRX-42 compared to a drug called sunitinib (standard-of-care treatment) in people who have been diagnosed with advanced gastrointestinal stromal tumor (GIST). The study focuses on patients with GIST that has spread to other parts of the body (metastatic GIST) and/or cannot be removed by surgery and who have experienced worsening of their disease while taking imatinib or cannot tolerate an anti-cancer drug called imatinib due to side effects. IDRX-42 is designed to block a mutated protein called KIT, preventing cancer cells from growing and spreading. Sunitinib is a medication that is available by prescription to treat gastrointestinal stromal tumor; it is used when the cancer gets worse after treatment with imatinib or when patients cannot tolerate imatinib. Participants will be randomly assigned to receive either IDRX-42 taken by mouth once daily or sunitinib taken by mouth once daily for 4 weeks, followed by a 2-week break. Study procedures also include physical examination, blood and urine lab sample collection, imaging scans, and questionnaires.
Eligibility
- * Participants with histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
- * Documented disease progression on or intolerance to imatinib administered for first-line treatment of unresectable/metastatic disease.
- * Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization.
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Emilie Douine-Barthelemy
More about this Clinical Trial
What is the full name of this clinical trial?
GSK300383: A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors after Imatinib Therapy *