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Clinical Trials List

Protocol Number300383
NCT Number(ClinicalTrials.gov Identfier)NCT07218926
Active

2025-10-01 - 2029-06-30

Phase III

Recruiting6

ICD-10C16.0

Malignant neoplasm of cardia

ICD-10C7A.092

Malignant carcinoid tumor of the stomach

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9151.0

Malignant neoplasm of cardia of stomach

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)

  • Trial Applicant

    GlaxoSmithKline

  • Sponsor

    GLAXOSMITHKLINE FAR EAST B.V., TAIWAN BRANCH (NETHERLANDS)

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/11

Investigators and Locations

Principal Investigator Chueh-Chuan Yen Division of Others -
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Tzong Chen Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳彥仰 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曾若涵 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

  • 林正純 Division of Hematology & Oncology
  • 王全正 Division of Hematology & Oncology
  • 林炫聿 Division of Hematology & Oncology
  • 張宏基 Division of Gastroenterological Surgery
  • 賴冠銘 Division of Hematology & Oncology
  • 石宇閎 Division of Hematology & Oncology
  • 林國華 Division of Gastroenterological Surgery
  • 黃晟維 Division of Hematology & Oncology
  • 張維容 Division of Gastroenterological Surgery

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Nan Yeh
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gastrointestinal Neoplasms

Objectives

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.

Test Drug

IDRX-42 (GSK6042981)
Sunitinib

Active Ingredient

IDRX-42 (GSK6042981)
Sunitinib

Dosage Form

Tablet
Capsule

Dosage

100 mg
12.5 mg

Endpoints

Progression-Free Survival (PFS) 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.

Inclution 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.

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    450 participants

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