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Protocol Number300383
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 was conducted to investigate the use of IDRX-42 (GSK6042981) versus Sunitinib in participants with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) who had received imatinib treatment (StrateGIST 3).

  • Trial Applicant

    GlaxoSmithKline

  • Sponsor

    GlaxoSmithKline Pharmaceuticals Ltd. Taiwan Branch

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/07

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

Metastatic and/or unresectable gastrointestinal stromal tumors (GISTs) following treatment with imatinib.

Objectives

Can IDRX-42 (GSK6042981) improve progression-free survival in metastatic and/or unresectable GISTs after failure of imatinib therapy, compared to sunitinib?

Test Drug

IDRX-42 (GSK6042981)
Sunitinib

Active Ingredient

IDRX-42 (GSK6042981)
Sunitinib

Dosage Form

Tablets
Capsules

Dosage

100 mg
12.5 mg

Endpoints

Compare the efficacy of IDRX-42 (GSK6042981) and sunitinib in participants with metastatic and/or unresectable GIST who have failed imatinib therapy, using progression-free survival (PFS) as evidence.

Inclution Criteria

1. Participants must be at least 18 years old.

2. Metastatic and/or unresectable gastrointestinal stromal tumors (GISTs) confirmed by histology or cytology.

3. Disease progression or intolerance to imatinib after first-line treatment for unresectable/metastatic disease.

4. Tumor tissue must be obtained and provided to a central laboratory for retrospective biomarker analysis. Samples can be from existing tissue or new slides. Centralized tissue samples are not required prior to randomization.

Exclusion Criteria

1. Known untreated or active central nervous system metastases.

2. Known hypersensitivity to any component of IDRX-42 (GSK6042981) or sunitinib. Participants who have developed Stevens-Johnson syndrome following treatment with a tyrosine kinase inhibitor (TKI) will be excluded from the trial.

3. Exclusion criteria: Basal cell carcinoma or squamous cell carcinoma of the skin (excluding diseases included in the trial) that has worsened or required aggressive treatment within the past [24 months], but has been surgically removed and shows no signs of metastatic disease (e.g., breast cancer, cervical cancer, bladder cancer).

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    450 participants

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