Clinical Trial 23996

• Overview

  Study Title:

  A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)

  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.

  Objective:

  Primary Objectives -To compare the efficacy of IDRX-42 (GSK6042981) to that of sunitinib in participants with metastatic and/or unresectable GIST after failure of imatinib therapy, as evidenced by PFS Secondary Objectives -To compare the efficacy of IDRX-42 (GSK6042981) to that of sunitinib - To assess HRQoL and functioning of IDRX-42 (GSK6042981) compared to sunitinib in participants with metastatic and/or unresectable GIST after failure of imatinib therapy - To describe the exposure of IDRX-42 (GSK6042981) - To assess the safety and tolerability of IDRX-42 (GSK6042981) in comparison with sunitinib - To assess symptomatic AEs and participant reported tolerability

• Treatments

  Therapies:

  Small molecule, tyrosine kinase inhibitor (TKI); Tyrosine Kinase Inhibitor

  Medications:

  IDRX-42 (GSK6042981) (); Sunitinib ()

• Inclusion Criteria

  Key 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

  Key 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.

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