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Clinical trial

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

NCT07004075 is registered in ClinicalTrials.gov with Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. as lead sponsor.

NCT NCT07004075
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Phase
Phase 3
Overall status
Not yet recruiting
Start date
June 30, 2025
Completion date
April 30, 2029
Enrollment
102 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

low-grade glioma, pediatric low-grade gliomas, plgg with braf alteration