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Active (not recruiting) Phase 2 2023-506464-14-00

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)

Phase 2 – studying effectiveness and dosage
Conditions: Advanced solid tumors

Sponsor: Turning Point Therapeutics Inc.

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Overview
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
Description
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
Who can participate
Age group: 18-64 years, 0-17 years Gender: Female, Male Target enrollment: 20 participants
Interventions
Repotrectinib (TPX-0005)
Drug
Repotrectinib (TPX-0005)
Drug
Repotrectinib (TPX-0005)
Drug
Locations 4
Denmark (1)
France (1)
Italy (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
No
Start date
07.02.2024
Registry ID
2023-506464-14-00
Source
euclinicaltrials.eu
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