Clinical Trial

FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration

Name: FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration — clinical trial record (NCT07004075)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Not Yet Recruiting Phase 3

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Summary

An open-label, randomized, multi-center phase III clinical study: Aim to evaluate the efficacy and safety of FCN-159 monotherapy versus the treatment by investigator's choice in patients with pediatric low-grade glioma harboring KIAA1549-BRAF fusion or BRAF V600E mutation

Trial Details

NCT Number	NCT07004075
Lead Sponsor	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions	Low-grade Glioma, Pediatric Low-grade Gliomas, pLGG With BRAF Alteration
Enrollment	102 participants
Start Date	2025-06-30
Primary Completion	2027-04-30 (estimated)
Study Completion	2029-04-30 (estimated)
Updated on ClinicalTrials.gov	2025-06-04