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A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
Trial Status: active
The purpose of this study is to find out if a new drug, called IDRX-42 (also known as
GSK6042981), is effective in treating adults with a type of cancer called
Gastrointestinal Stromal Tumors (GIST) when compared to another drug named sunitinib. The
study will see if IDRX-42 works well and is safe for participants whose GIST has spread
or cannot be surgically removed, and who have already taken the drug imatinib.
Inclusion Criteria
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.
Exclusion Criteria
Known untreated or active central nervous system metastases.
Participants with a known allergy or hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants with a history of Stevens-Johnson syndrome on a prior Tyrosine kinase inhibitor (TKI) are excluded.
Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07218926.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Approved
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Approved
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Michigan
Ann Arbor
University of Michigan Rogel Cancer Center
Status: Approved
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Approved
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center