IDRX-42 versus sunitinib for adults with advanced gastrointestinal stromal tumors after imatinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized interventional trial compares oral IDRX-42 (GSK6042981) to sunitinib in adults with metastatic or unresectable gastrointestinal stromal tumors (GIST) whose disease progressed on or who are intolerant to imatinib. Participants will be assigned to receive either IDRX-42 or sunitinib and will be followed for tumor response, progression-free survival, and safety outcomes. Tumor tissue (archival or new biopsy) will be submitted for central retrospective biomarker analysis to explore markers of response. Key exclusions include active untreated central nervous system metastases, prior severe hypersensitivity to the study drugs, and recent other progressing malignancies.

Why it matters

Who can join: the full rules

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.
* 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.

Exclusion Criteria:

* GIST that is both KIT and PDGFRA wild-type or known to harbor an activating PDGFRA exon 18 mutation.
* 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.

Where it's running

• GSK Investigational Site
  Phoenix, Arizona, United States Recruiting
• GSK Investigational Site
  Duarte, California, United States Recruiting
• GSK Investigational Site
  La Jolla, California, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  San Francisco, California, United States Recruiting
• GSK Investigational Site
  Santa Monica, California, United States Recruiting

+106 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.