Study Comparing IDRX-42 and Sunitinib for Treating Gastrointestinal Stromal Tumors After Imatinib Therapy

Sponsor: GlaxoSmithKline

Sponsor score: 60

ClinicalTrials ID:NCT07218926

Provider View

This clinical trial is testing a new drug, IDRX-42, to see if it is effective and safe for adults with Gastrointestinal Stromal Tumors (GIST) that have spread or cannot be removed by surgery, and who have already been treated with imatinib. The study compares IDRX-42 to another drug called sunitinib.

Patient Parameters

Program Overview

The aim of this study is to determine if a new medication, IDRX-42, is effective in treating adults with Gastrointestinal Stromal Tumors (GIST) compared to the drug sunitinib. This study focuses on patients whose GIST has either spread to other parts of the body or cannot be surgically removed, and who have previously been treated with imatinib. Researchers will evaluate how well IDRX-42 works and its safety for these patients.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Gastrointestinal Stromal Tumors (GIST) that have spread or cannot be surgically removed.
  • Have experienced disease progression or cannot tolerate imatinib, which was used as the first treatment for their condition.
  • Must provide a tumor tissue sample for analysis, which can be from a previous biopsy or a new one. This sample does not need to be submitted before starting the study.

Exclusion Criteria

  • Have untreated or active cancer that has spread to the brain or spinal cord.
  • Have an allergy or sensitivity to any part of the drugs IDRX-42 or sunitinib. Also, those who have had a severe skin reaction called Stevens-Johnson syndrome from similar drugs are excluded.
  • Have another type of cancer that has worsened or needed treatment in the last two years, except for certain skin cancers or in-situ cancers that have been removed and have not spread.

Locations

FACILITYZIPCITYSTATE
GSK Investigational Site68130OmahaNebraska
GSK Investigational Site77030HoustonTexas
GSK Investigational Site98405TacomaWashington

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