A Study of Velzatinib in Participants With Metastatic and/or Unresectable GIST After Imatinib, Sunitinib, Regorafenib, and Pimitespib

Официальное название

A Phase 2, Single-arm, Multicenter, Open-Label Study of Velzatinib (GSK6042981) in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) After Imatinib, Sunitinib, Regorafenib, and Pimitespib Therapies (StrateGIST J)

Обзор

The goal of this study is to evaluate the study drug velzatinib (GSK6042981 / IDRX-42) to see whether velzatinib can shrink or control tumors and is safe and tolerated in Japan participants with gastrointestinal tumors (GIST) who progressed or were intolerant to standard therapies.

Вмешательства

• Препарат Velzatinib
  Velzatinib will be administered.

Первичные конечные точки

• Confirmed objective response rate (ORR) [Срок оценки: Up to 67 weeks]

Вторичные конечные точки (9)

• Duration of response (DOR) [Срок оценки: Up to 156 weeks]
• Disease control rate for minimum 8-week period (DCR8) [Срок оценки: Up to 156 weeks]
• Progression free survival (PFS) [Срок оценки: Up to 156 weeks]
• Overall survival (OS) [Срок оценки: Up to 156 weeks]
• Confirmed ORR [Срок оценки: Up to 156 weeks]
• Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-F17 (EORTC-QLQ-F17) [Срок оценки: Baseline (Day 1) up to 156 weeks]
• Change from baseline in EQ-5D-5L score [Срок оценки: Baseline (Day 1) up to 156 weeks]
• Plasma concentrations of velzatinib [Срок оценки: Up to 156 weeks]
• Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), dose reductions and interruptions and discontinuation of study treatment due to toxicity by severity [Срок оценки: Up to 156 weeks]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed GIST that is metastatic and/or surgically unresectable.
• Documented disease progression on or intolerance to imatinib, sunitinib, regorafenib, and pimitespib.
• Documented mutation status of KIT and/or PDGFRA.
• Tumor tissue must be available for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy.
• Is willing to use adequate contraception male and/or female participants.

Критерии исключения

• Known untreated or active central nervous system metastases.
• Has significant, uncontrolled, or active cardiovascular disease.
• Participants with a known allergy or hypersensitivity to any component of velzatinib. 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.
• Prior treatment with ripretinib or other investigational agents that are currently under clinical development for GIST.
• Is pregnant or breastfeeding.
• Any condition or illness that, in the opinion of the Investigator, might compromise participant safety or interfere with the evaluation of the safety of the study treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07689201 · 309344

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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