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Набира участници Фаза 2 NCT04775485

A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Low-grade Glioma Advanced Solid Tumor

Спонсор: Day One Biopharmaceuticals, Inc.

Налично на: БГ
Обобщение
This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.
Кой може да участва
Inclusion Criteria: * Low Grade Glioma \& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration. * Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion. * Participants must have histopathologic verification of malignancy at either original diagnosis or relapse. * Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression. * Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria Exclusion Criteria: * Participant's tumor has additional previously-known activating molecular alterations. * Participant has symptoms of without radiographically recurrent or radiographically progressive disease. * Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria. Other inclusion/exclusion criteria as stipulated by protocol may apply
Места на провеждане 10
Австралия (1)
Queensland Children's Hospital
Brisbane
Канада (1)
Centre Hospitalier Universitaire Ste-Justine
Montreal , Quebec
Дания (1)
Rigshospitalet
Copenhagen
Израел (1)
Rambam Health Care Campus
Haifa
Нидерландия (1)
Princess Maxima Center for Pediatric Oncology
Utrecht
Сингапур (1)
KK Women's and Children's Hospital
Singapore
Южна Корея (1)
Seoul National University Hospital
Seoul
Швейцария (1)
Universitäts-Kinderspital Zürich - Eleonorenstiftung
Zurich
Великобритания (1)
UCL Great Ormond Street Institute of Child Health
London
САЩ (1)
UCSF Benioff Children's Hospital
San Francisco , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
6 Months
Максимална възраст
25 Years
Здрави доброволци
Не
Начална дата
22.04.2021
Крайна дата
31.05.2027
Регистрационен номер
NCT04775485
Източник
anzctr
Запитване за медицински туризъм

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