A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy
- Conditions
- Gastrointestinal Neoplasms
- Interventions
- Registration Number
- NCT07218926
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDRX-42 (GSK6042981) IDRX-42 - Sunitinib Sunitinib -
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Up to approximately 130 weeks PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to approximately 261 weeks OS is defined as time from the date of randomization to the date of death due to any cause.
Progression-Free Survival (PFS) Up to approximately 261 weeks PFS is defined as time from the date of randomization to the date of disease progression or death due to any cause, whichever occurs first.
Confirmed Overall Objective Response Rate (ORR) Up to approximately 261 weeks ORR is defined as the percentage of participants with the best overall confirmed partial response (PR) or better.
Time to Response (TTR) Up to approximately 261 weeks TTR is defined as time from randomization until the first documented PR or complete response (CR) that will be subsequently confirmed.
Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2) Up to approximately 261 weeks PFS2 is defined as the time from initial study randomization to second disease progression or death after starting the next line of treatment.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Baseline (Day 1) and up to approximately 261 weeks The EORTC QLQ-C30 includes 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. These include functional scales, symptom scales, global health status scale, and single item scales. Scores are averaged and transformed to 0 to 100. Higher scores indicate greater functioning, better global health status, or more severe symptoms
Time To Confirmed Deterioration (TTCD) Up to approximately 261 weeks TTCD is defined as the time from the date of randomization to the first confirmed clinically meaningful deterioration based on the EORTC QLQ-C30.
Plasma concentrations of IDRX-42 (GSK6042981) Up to approximately 261 weeks Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Up to approximately 261 weeks Number of Participants with TEAEs and SAEs by severity Up to approximately 261 weeks Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity 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) Up to approximately 261 weeks The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicities in participants in cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
Number of participants with bothersome AEs/tolerability as measured by the Functional Assessment of Cancer Therapy - General (FACT-GP5) Up to approximately 261 weeks The FACT GP5 is an assessment focused on the overall side effects impact to inform the tolerability of a treatment. The FACT GP5 ("I am bothered by side effects of treatment") responses are given on a 5-point Likert type scale. The response scale ranges from 0 (Not at all) to 4 (Very much). Higher scores indicate a higher degree of AE bother.