- A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy — Recruiting • Phase III • Oncology • NCT07218926.
- What is being tested: IDRX-42 (GSK6042981), a novel investigational drug, is being evaluated against sunitinib (standard comparator) in adults with gastrointestinal stromal tumors (GIST) who have progressed despite prior imatinib therapy.
- Patient eligibility overview: The trial enrolls adult patients with GIST who have received and are no longer responding to imatinib treatment, representing a treatment-resistant population requiring alternative therapeutic options.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion…
- : * 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. * Documented mutation status of KIT and/or PDGFRA using a tissue based next-generation sequencing or polymerase chain reaction (PCR) assay. * Tumor tissue must be available for retrospective biomarker analysis. Sample may be archival or new biopsy.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.