Gastrointestinal Neoplasms
Conditions
Keywords
GSK6042981, IDRX-42, Sunitinib, Imatinib, Gastrointestinal Stromal Tumors
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. Participants whose disease worsens after receiving sunitinib in this study may cross over to receive GSK6042981, at investigator's discretion and if additional eligibility criteria are met.
Interventions
DRUGIDRX-42
IDRX-42 will be administered.
DRUGSunitinib
Sunitinib will be administered.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 complete response (CR). |
| 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 the disease progression following first subsequent anticancer therapy or death, whichever is first. |
| 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. |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed