NCT02367859

Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To observe the response rate of ameloblastoma to dabrafenib and trametinib at 6 weeks. SECONDARY OBJECTIVES: I. Feasibility and safety in this patient population. II. Response will be assessed pathologically. III. Two main histologic assays for treatment response will be used: tumor necrosis and phosphorylated-mitogen-activated protein kinase kinase 1 (MEK), phosphorylated-extracellular signal-regulated kinase (ERK), and Ki-67 levels as measured by immunohistochemistry. OUTLINE: Patients receive dabrafenib orally (PO) twice daily (BID) every 12 hours and trametinib 2 mg daily PO for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease is judged to be not amenable to resection will continue dabrafenib and trametinib indefinitely as long as there has not been tumor progression. After completion of study treatment, patients are followed up for at least 4 weeks.

Conditions

• Ameloblastoma
• BRAF Gene Mutation

Interventions

Type	Name	Description
DRUG	Dabrafenib	Given PO
DRUG	Trametinib	Given PO

Timeline

• Start date: 2017-07-17
• Primary completion: 2018-11-05
• Completion: 2019-06-26
• First posted: 2015-02-20
• Last updated: 2024-01-30
• Results posted: 2020-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study