A Study of IDRX-42 (GSK6042981) versus (vs) sunitinib in Participants with Gastrointestinal Stromal Tumors after imatinib Therapy
Trial overview
Progression-Free Survival (PFS)
Timeframe: Up to approximately 130 weeks
Overall Survival (OS)
Timeframe: Up to approximately 261 weeks
Progression-Free Survival (PFS)
Timeframe: Up to approximately 261 weeks
Confirmed Overall Objective Response Rate (ORR)
Timeframe: Up to approximately 261 weeks
Time to Response (TTR)
Timeframe: Up to approximately 261 weeks
Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2)
Timeframe: Up to approximately 261 weeks
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)
Timeframe: Baseline (Day 1) and up to approximately 261 weeks
Time To Confirmed Deterioration (TTCD)
Timeframe: Up to approximately 261 weeks
Plasma concentrations of IDRX-42 (GSK6042981)
Timeframe: Up to approximately 261 weeks
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Up to approximately 261 weeks
Number of Participants with TEAEs and SAEs by severity
Timeframe: Up to approximately 261 weeks
Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity
Timeframe: Up to approximately 261 weeks
Number of participants with symptomatic adverse events (AEs), by severity, as measured by the Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Timeframe: Up to approximately 261 weeks
Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5)
Timeframe: Up to approximately 261 weeks
Participation 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.
- 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.
•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.
•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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.