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- Withdrawn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
- Dabrafenib Mesylate — DRUGGiven PO
- Quality-of-Life Assessment — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
- Trametinib Dimethyl Sulfoxide — DRUGGiven PO
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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