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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат IDRX-42
  IDRX-42 will be administered.
• Препарат Sunitinib
  Sunitinib will be administered.

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 130 weeks]

Вторичные конечные точки (12)

• Overall Survival (OS) [Срок оценки: Up to approximately 261 weeks]
• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 261 weeks]
• Confirmed Overall Objective Response Rate (ORR) [Срок оценки: Up to approximately 261 weeks]
• Time to Response (TTR) [Срок оценки: Up to approximately 261 weeks]
• Time from initial study randomization to second disease progression or death after starting the next line of treatment (PFS2) [Срок оценки: 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) [Срок оценки: Baseline (Day 1) and up to approximately 261 weeks]
• Time To Confirmed Deterioration (TTCD) [Срок оценки: Up to approximately 261 weeks]
• Plasma concentrations of IDRX-42 (GSK6042981) [Срок оценки: Up to approximately 261 weeks]
• Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 261 weeks]
• Number of Participants with TEAEs and SAEs by severity [Срок оценки: Up to approximately 261 weeks]
• Number of Participants with dose reductions, interruptions and discontinuation of study treatment due to toxicity [Срок оценки: 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) [Срок оценки: Up to approximately 261 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 36 центров

• 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
• … и ещё 28 центров

Япония · 10 центров

• GSK Investigational Site — Chiba
• GSK Investigational Site — Ehime
• GSK Investigational Site — Fukuoka
• GSK Investigational Site — Hokkaido
• GSK Investigational Site — Kanagawa
• … и ещё 5 центров

Италия · 9 центров

• 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
• … и ещё 1 центр

Испания · 9 центров

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Франция · 8 центров

• 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 центров

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Великобритания · 7 центров

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Китай · 6 центров

• GSK Investigational Site — Шанхай
• GSK Investigational Site — Пекин
• GSK Investigational Site — Ханчжоу
• GSK Investigational Site — Цзинань
• GSK Investigational Site — Шанхай
• GSK Investigational Site — Ухань

Тайвань · 6 центров

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Бразилия · 5 центров

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

Румыния · 4 центра

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Австралия · 3 центра

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

Канада · 3 центра

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

Германия · 3 центра

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

Польша · 3 центра

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Бельгия · 1 центр

• GSK Investigational Site — Leuven

Венгрия · 1 центр

• GSK Investigational Site — Pécs

Нидерланды · 1 центр

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Норвегия · 1 центр

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Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗