drugset / Trial / NCT05525273

Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma

NCT05525273

Phase 2 Recruiting 25 enrolled Eva Marie Erfurth, MD, PhD Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

Subjects with papillary craniopharyngioma harboring a BRAF mutation will be treated with a BRAF + MEK inhibitor (dabrafenib + trametinib) after informed consent. Study participants will be administered oral dabrafenib and trametinib until maximal tumor volume reduction assessed by MRI. Progression free survival, cognition, ophthalmologic status, hypothalamic status and quality of life will be assessed 1 year after initiation of study treatment

Timeline

Start
2023-09-01
Primary completion
2027-09-10
Completion
2028-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabrafenib Small molecule 75 mg Oral
Subject Trametinib Small molecule 2 mg Oral

Indications