A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Antitumor
Activity Study of Repotrectinib in Pediatric and Young Adult Subjects
with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or
NTRK1-3 Alterations (CARE)
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Advanced solid tumors
Спонсор: Turning Point Therapeutics Inc.
Налично на:
БГ
Обобщение
Trial status: Authorised
DOR, TTR and CBR, Intracranial tumor response, Central nervous system (CNS) progression-free survival (CNS-PFS) in subjects with measurable brain metastases, PFS and OS, PK parameters, Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities
ORR as determined by BICR
Описание
DOR, TTR and CBR, Intracranial tumor response, Central nervous system (CNS) progression-free survival (CNS-PFS) in subjects with measurable brain metastases, PFS and OS, PK parameters, Type, incidence, severity, timing, seriousness, and relatedness of AEs and laboratory abnormalities
Кой може да участва
Age group: 18-64 years, 0-17 years
Gender: Female, Male
Target enrollment: 20 participants