Dabrafenib and Trametinib in Treating Patients With Erdheim Chester Disease With BRAF V600 Mutations

Part of paid clinical trials in Houston, Texas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03794297
Phase
PHASE2
Status
Withdrawn

Conditions

  • Erdheim-Chester Disease

Eligibility Criteria

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

Interventions

Study Details

This phase II trial studies the side effects and how well dabrafenib and trametinib work in treating patients with Erdheim Chester disease that have BRAF V600 gene mutations. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Jan 4, 2019
Status verified
Mar 2021
Primary completion
Feb 18, 2021
Completion
Feb 18, 2021

Study Design

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

Arms

  • Experimental: Treatment (dabrafenib mesylate, trametinib dimethyl sulfoxide)
    Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO QD on days 1-28. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Clinical response rate [ Time Frame: Up to 48 weeks after completion of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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