Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma
ConditionCraniopharyngioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEva Marie Erfurth, MD, PhD
About this trial
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
Eligibility criteria
Qualifiers
Histologically verified papillary craniopharyngioma.
BRAF mutated V600E (valine 600 glutamine), verified immunohistochemically and by molecular genetic analysis
Newly diagnosed tumor, or recurrence after previous surgery, where surgery is not considered to be able to be performed radically without the risk of serious or permanent sequelae.
Age over 18 years
Disqualifiers
Ongoing treatment in another drug study or other experimental treatment.
Previous treatment with BRAF or MEK inhibitors.
Hypersensitivity to study drugs.
Ongoing treatment with non-authorized drugs, (strong inducers of CYP2C8 or CYP3A4). If the patient is on unauthorized drugs, they must be discontinued at least 14 days before inclusion.
Trial design
Treatments tested in this trial
- Oral dabrafenib and trametinib
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Eva Marie Erfurth, MD, PhD
Lead sponsor
Skane University Hospital
Sponsor institution
Novartis
Collaborator
Source ClinicalTrials.gov