Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma (NCT02367859) | Clinical Trial Compass
CompletedPhase 2
Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma
United States1 participantsStarted 2017-07-17
Plain-language summary
This pilot clinical trial studies dabrafenib and trametinib in treating patients with ameloblastoma and a specific mutation (change) in the BRAF gene. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological diagnosis of ameloblastoma; all stages are eligible; patients must have evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E or other known dabrafenib sensitive BRAF mutation in tumor by any Clinical Laboratory Improvement Amendments (CLIA) certified lab; may include, for example, Sanger sequencing, SNaPshot platform, immunohistochemistry, Foundation One tests, etc.)
* Life expectancy \> 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Absolute neutrophil count (ANC) \> 1.5 x10\^9/L
* Platelet (PLT) \> 99 x 10\^9/L
* Hemoglobin \> 8 g/dL
* Total bilirubin (Tbili) \< 1.6 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 2.6 x ULN
* Alkaline phosphatase (alk phos) \< 2.6 x ULN
* Serum creatinine \< 1.6 x ULN or creatinine clearance \> 50 ml/min
* Ability to understand and the willingness to sign a written informed consent document
* Patients of childbearing potential must agree to use effective contraception until at least 6 months after treatment with dabrafenib
* Able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
* Left ventricular ejection fraction equal to or greater than normal
Exclusion Criteria:
* No…