Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT02367859
Phase
PHASE2
Status
Completed

Conditions

  • Ameloblastoma
  • BRAF Gene Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 17, 2017
Status verified
Jan 2024
Primary completion
Nov 5, 2018
Completion
Jun 26, 2019

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (dabrafenib)
    Patients receive dabrafenib PO BID every 12 hours plus trametinib 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.

Primary Outcome Measure

Tumor Response [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University, School of MedicineStanfordCalifornia94305-

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Stanford University, School of Medicine· Stanford, CA

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