Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngiom
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, cognit
| Condition(s) | Craniopharyngioma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. Histologically verified papillary craniopharyngioma. 2. BRAF mutated V600E (valine 600 glutamine), verified immunohistochemically and by molecular genetic analysis 3. 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. 4. Age over 18 years 5. Functional status according to ECOG (Eastern Cooperative Oncology Group performance status) 0-2 6. Adequate organ function: neutrophils\> 1.5 x 109 platelets\> 100 x 109 creatinine \<1.5 x ULN (upper limit of normal) or creatinine clearance \<45 ml / min bilirubin \<1.5 x ULN ASAT (aspartate aminotransferase) / ALAT (alanine aminotransferase) \<2.5 x ULN 7. Ability to understand and give informed conse |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Eva Marie Erfurth, MD, PhD |
| Locations | Lund, Sweden |
| Start date | 2023-09-01 |
| NCT ID | NCT05525273 |
| Official listing | https://clinicaltrials.gov/study/NCT05525273 |