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Recruiting Phase 3 NCT07218926

A Study of IDRX-42 (GSK6042981) Versus (vs) Sunitinib in Participants With Gastrointestinal Stromal Tumors After Imatinib Therapy

Phase 3 – large-scale trial before approval
Conditions: Gastrointestinal Neoplasms

Sponsor: GlaxoSmithKline

trial.available_in: БГ
Overview
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.
Who can participate
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. * 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. Exclusion Criteria: * 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.
Locations 18
Australia (1)
GSK Investigational Site
Melbourne , Victoria
US GSK Clinical Trials Call Center
Belgium (1)
GSK Investigational Site
Leuven
US GSK Clinical Trials Call Center
Brazil (1)
GSK Investigational Site
Barretos , São Paulo
US GSK Clinical Trials Call Center
Canada (1)
GSK Investigational Site
Toronto , Ontario
US GSK Clinical Trials Call Center
China (1)
GSK Investigational Site
Beijing
US GSK Clinical Trials Call Center
France (1)
GSK Investigational Site
Bordeaux
US GSK Clinical Trials Call Center
Germany (1)
GSK Investigational Site
Berlin
US GSK Clinical Trials Call Center
Italy (1)
GSK Investigational Site
Meldola , FC
US GSK Clinical Trials Call Center
Japan (1)
GSK Investigational Site
Chiba
US GSK Clinical Trials Call Center
Netherlands (1)
GSK Investigational Site
Nijmegen
US GSK Clinical Trials Call Center
Norway (1)
GSK Investigational Site
Oslo
US GSK Clinical Trials Call Center
Poland (1)
GSK Investigational Site
Kielce
US GSK Clinical Trials Call Center
Romania (1)
GSK Investigational Site
Bucharest
US GSK Clinical Trials Call Center
South Korea (1)
GSK Investigational Site
Daegu
US GSK Clinical Trials Call Center
Spain (1)
GSK Investigational Site
Barcelona
US GSK Clinical Trials Call Center
Taiwan (1)
GSK Investigational Site
Changhua
US GSK Clinical Trials Call Center
United Kingdom (1)
GSK Investigational Site
Cambridge
US GSK Clinical Trials Call Center
United States (1)
GSK Investigational Site
Phoenix , Arizona
US GSK Clinical Trials Call Center
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.12.2025
Completion date
29.11.2030
Registry ID
NCT07218926
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.