Recruiting NCT07218926

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

Phase III Interventional Gastrointestinal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: IDRX-42, Sunitinib.
Who it may be relevant to: Registry conditions: Gastrointestinal Neoplasms. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, Canada +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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)

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. 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.

Interventions

Drug IDRX-42
IDRX-42 will be administered.
Drug Sunitinib
Sunitinib will be administered.

Primary outcome measures

Progression-Free Survival (PFS) [Time frame: Up to approximately 130 weeks]

Secondary outcome measures (12)

Overall Survival (OS) [Time frame: Up to approximately 261 weeks]
Progression-Free Survival (PFS) [Time frame: Up to approximately 261 weeks]
Confirmed Overall Objective Response Rate (ORR) [Time frame: Up to approximately 261 weeks]
Time to Response (TTR) [Time frame: Up to approximately 261 weeks]
Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2) [Time frame: Up to approximately 261 weeks]
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) [Time frame: Baseline (Day 1) and up to approximately 261 weeks]
Time To Confirmed Deterioration (TTCD) [Time frame: Up to approximately 261 weeks]
Plasma concentrations of IDRX-42 (GSK6042981) [Time frame: Up to approximately 261 weeks]
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Up to approximately 261 weeks]
Number of Participants with TEAEs and SAEs by severity [Time frame: Up to approximately 261 weeks]
Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity [Time frame: Up to approximately 261 weeks]
Number of participants with symptomatic adverse events (AEs), by severity, as measured by the Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Time frame: Up to approximately 261 weeks]

Eligibility criteria

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.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 36 centers

GSK Investigational Site — Phoenix
GSK Investigational Site — La Jolla
GSK Investigational Site — Los Angeles
GSK Investigational Site — San Francisco
GSK Investigational Site — New Haven
GSK Investigational Site — Jacksonville
GSK Investigational Site — Miami
GSK Investigational Site — Orlando
… and 28 more centers

Japan · 10 centers

GSK Investigational Site — Chiba
GSK Investigational Site — Ehime
GSK Investigational Site — Fukuoka
GSK Investigational Site — Hokkaido
GSK Investigational Site — Kanagawa
… and 5 more centers

Italy · 9 centers

GSK Investigational Site — Meldola
GSK Investigational Site — Rozzano MI
GSK Investigational Site — Bari
GSK Investigational Site — Candiolo
GSK Investigational Site — Genova
GSK Investigational Site — Milan
GSK Investigational Site — Milan
GSK Investigational Site — Palermo
… and 1 more center

Spain · 9 centers

Center list to be confirmed — check the primary protocol.

France · 8 centers

GSK Investigational Site — Angers
GSK Investigational Site — Bordeaux
GSK Investigational Site — Lille
GSK Investigational Site — Lyon
GSK Investigational Site — Marseille
GSK Investigational Site — Saint-Herblain
GSK Investigational Site — Toulouse
GSK Investigational Site — Villejuif

South Korea · 8 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 7 centers

Center list to be confirmed — check the primary protocol.

China · 6 centers

GSK Investigational Site — Shanghai
GSK Investigational Site — Beijing
GSK Investigational Site — Hangzhou
GSK Investigational Site — Jinan
GSK Investigational Site — Shanghai
GSK Investigational Site — Wuhan

Taiwan · 6 centers

Center list to be confirmed — check the primary protocol.

Brazil · 5 centers

GSK Investigational Site — Barretos
GSK Investigational Site — São Caetano do Sul
GSK Investigational Site — Porto Alegre
GSK Investigational Site — Recife
GSK Investigational Site — Vitória

Romania · 4 centers

Center list to be confirmed — check the primary protocol.

Australia · 3 centers

GSK Investigational Site — Garran
GSK Investigational Site — Westmead
GSK Investigational Site — Melbourne

Canada · 3 centers

GSK Investigational Site — Calgary
GSK Investigational Site — Toronto
GSK Investigational Site — Montreal

Germany · 3 centers

GSK Investigational Site — Berlin
GSK Investigational Site — Essen
GSK Investigational Site — Mannheim

Poland · 3 centers

Center list to be confirmed — check the primary protocol.

Belgium · 1 center

GSK Investigational Site — Leuven

Hungary · 1 center

GSK Investigational Site — Pécs

Netherlands · 1 center

Center list to be confirmed — check the primary protocol.

Norway · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07218926 · 300383 · 2025-522229-37-00

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗