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Набира участници Фаза 3 NCT07218926

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Gastrointestinal Neoplasms

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
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.
Кой може да участва
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. * Tumor tissue must be available to be submitted to the central laboratory for retrospective biomarker analysis. The sample may be from archival tissue or a new biopsy. Tissue samples are not required to be submitted centrally prior to randomization. Exclusion Criteria: * 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.
Места на провеждане 18
Австралия (1)
GSK Investigational Site
Melbourne , Victoria
US GSK Clinical Trials Call Center
Белгия (1)
GSK Investigational Site
Leuven
US GSK Clinical Trials Call Center
Бразилия (1)
GSK Investigational Site
Barretos , São Paulo
US GSK Clinical Trials Call Center
Канада (1)
GSK Investigational Site
Toronto , Ontario
US GSK Clinical Trials Call Center
Китай (1)
GSK Investigational Site
Beijing
US GSK Clinical Trials Call Center
Франция (1)
GSK Investigational Site
Bordeaux
US GSK Clinical Trials Call Center
Германия (1)
GSK Investigational Site
Berlin
US GSK Clinical Trials Call Center
Италия (1)
GSK Investigational Site
Meldola , FC
US GSK Clinical Trials Call Center
Япония (1)
GSK Investigational Site
Chiba
US GSK Clinical Trials Call Center
Нидерландия (1)
GSK Investigational Site
Nijmegen
US GSK Clinical Trials Call Center
Норвегия (1)
GSK Investigational Site
Oslo
US GSK Clinical Trials Call Center
Полша (1)
GSK Investigational Site
Kielce
US GSK Clinical Trials Call Center
Румъния (1)
GSK Investigational Site
Bucharest
US GSK Clinical Trials Call Center
Южна Корея (1)
GSK Investigational Site
Daegu
US GSK Clinical Trials Call Center
Испания (1)
GSK Investigational Site
Barcelona
US GSK Clinical Trials Call Center
Taiwan (1)
GSK Investigational Site
Changhua
US GSK Clinical Trials Call Center
Великобритания (1)
GSK Investigational Site
Cambridge
US GSK Clinical Trials Call Center
САЩ (1)
GSK Investigational Site
Phoenix , Arizona
US GSK Clinical Trials Call Center
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
03.12.2025
Крайна дата
29.11.2030
Регистрационен номер
NCT07218926
Източник
anzctr
Запитване за медицински туризъм

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