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

Sponsor
Eva Marie Erfurth, MD, PhD
Study ID
NCT05525273
Phase
PHASE2
Status
Recruiting
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Conditions

  • Craniopharyngioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Sep 1, 2023
Status verified
Feb 2024
Primary completion
Sep 10, 2027
Completion
Apr 10, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dabrafenib and trametinib
    Dabrafenib 75 mg twice daily and trametinib 2 mg once daily

Primary Outcome Measure

Tumor response [ Time Frame: 1 month to 5 years (sliding timepoints) ]

Central Contacts

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