Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma

Not Recruiting

Trial ID: NCT02367859


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.

Official Title

A Pilot Study of Dabrafenib and Trametinib for Patients With BRAF Mutated Ameloblastoma

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Robert West
Robert West

Professor of Pathology


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 prior treatment with agents targeting BRAF mutant tyrosine kinases or radiation of
   target lesions

   - Invasive malignancy other than ameloblastoma within 3 years, excluding curatively
   treated basal cell carcinoma, and other highly curable cancers such as early stage
   cutaneous squamous cell carcinoma (T1 NO) cervical carcinoma in situ (CIS), early
   stage prostate cancer, thyroid cancer or breast cancer

   - Uncontrolled hypertension, chronic heart failure (CHF), or other major medical illness

   - Prior allergic reactions attributed to compounds of similar chemical or biologic
   composition to dabrafenib

   - Concomitant use of strong inhibitors (e.g., ketoconazole, nefazodone, clarithromycin,
   gemfibrozil) or strong inducers (e.g., rifampin, phenytoin, carbamazepine,
   phenobarbital, St John's wort) of cytochrome P450, family 3, subfamily A, polypeptide
   4 (CYP3A4) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8)

   - Concomitant use of proton pump inhibitors, H2-receptor antagonists, antacids

   - Known glucose-6-phosphate dehydrogenase (G6PD) deficiency

   - Pregnant or nursing patients; women of childbearing potential must have a negative
   pregnancy test within 14 days of enrollment

   - Electrocardiogram (EKG) with QTcB (Bazett's formula) > 480 ms done within 14 days of

   - Interstitial lung disease or pneumonitis

   - A history of retinal vein occlusion (RVO)

   - Congestive heart failure NYHA class III or worse (Marked limitation of physical
   activity. Comfortable at rest. Less than ordinary activity causes fatigue,
   palpitation, or dyspnea.)

   - A history of acute coronary syndromes (including myocardial infarction or unstable
   angina), coronary angioplasty, or stenting within 6 months


drug: Trametinib

drug: Dabrafenib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Winters

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