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Last Updated: August 10, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR DABRAFENIB MESYLATE

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All Clinical Trials for Dabrafenib Mesylate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02281760 Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease Recruiting National Human Genome Research Institute (NHGRI) Phase 2 2014-10-01 Erdheim-Chester Diseases (ECD) is a very rare non-Langerhans cell histiocytosis of unknown origin and pathogenesis. It has been reported mainly in adult males over the age of 40 years, although cases have been reported in females as well. Children are rarely affected. Mutation of the BRAF gene, specifically BRAFV600E, has been recently identified in 50% of Erdheim Chester lesions in a French cohort. This somatic mutation is believed to be the driver mutation in positive cases. The clinical characteristics of ECD range from asymptomatic to multisystemic involvement; longitudinal progression and natural history are becoming better understood. ECD commonly affects the bones, kidneys, retroperitoneal space, skin and brain. If untreated, the disease progresses rapidly, causing fatal outcomes due to severe lung disease, chronic renal failure, cardiomyopathy and other complications. The diagnosis of ECD relies upon imaging studies and specific pathologic findings in biopsies of affected organs, i.e., fibrosis and infiltration of tissues with foamy histiocytes, lymphocytes, and plasma cells. Immunohistochemistry reveals cells positive for CD68 and CD163 and negative for CD1a, with 20% positivity to S-100. There is no standard treatment for ECD, although chemotherapy, radiation, stem cell transplantion, alpha-interferon, anakinra, imatinib and sirolimus have been proposed. The recent discovery of the BRAFV600E mutation in several ECD patients has opened a new area for treatment options. Vemurafenib, an FDA approved BRAF inhibitor for the treatment of patients with metastatic or unresectable melanoma with the V600E mutation, binds to this form of mutated BRAF causing protein inactivation. The use of vemurafenib in patients with ECD has been reported in 3 patients who experienced remission of the disease, and is currently being studied in the U.S. and Europe as monotherapy. Tumor/disease resistance to vemurafenib has occurred in melanoma and other cancers, although it has not been reported in patients with ECD. In this protocol, we propose to clinically evaluate ECD patients with the BRAFV600E mutation and administer combination therapy with dabrafenib, a BRAFV600E inhibitor, and trametinib, an inhibitor of MEK, downstream of BRAF. Screening for possible contraindications will be made prior to the administration of the first dose. With this trial, we will determine the safety, tolerability, and efficacy of dabrafenib and trametinib in patients with ECD who harbor the BRAFV600E mutation. Dabrafenib 150mg will be given twice daily p.o.; trametinib 2mg will be given once daily p.o. Patients will be seen 1 week, 1 month, 2 months, 4 months, and 6 months, 8 months, 10 months and 12 months to complete a oneyear trial.
NCT02501551 Regorafenib, C-kit Mutated Malignant Melanoma, 2nd Line Therapy Recruiting Yonsei University Phase 2 2015-02-01 This is a phase II trial of regorafenib in patients with metastatic melanoma harboring c-Kit mutations and/or amplifications of c-Kit gene copy number. The primary end point is disease control rate (DCR), and the secondary end points are safety, response rate (RR), progression free survival (PFS), and overall survival (OS).
NCT03299452 Clinical Studies by Using Accelerated PDX Model to Screen Drugs for Advanced Solid Tumor Recruiting Haining Health-Coming Biotech Co., Ltd. Phase 2 2017-01-01 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS,safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on the accelerated PDX model screening in subjects with advanced malignant tumor.
NCT03794297 Dabrafenib and Trametinib in Treating Patients With Erdheim Chester Disease With BRAF V600 Mutations Not yet recruiting National Cancer Institute (NCI) Phase 2 2020-01-12 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dabrafenib Mesylate

Condition Name

Condition Name for Dabrafenib Mesylate
Intervention Trials
BRAF NP_004324.2:p.V600X 2
Refractory Plasma Cell Myeloma 1
BRAF V600E Mutation 1
Low Grade Glioma (LGG) of Brain With BRAF Aberration 1
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Condition MeSH

Condition MeSH for Dabrafenib Mesylate
Intervention Trials
Erdheim-Chester Disease 2
Glioma 2
Astrocytoma 1
Neurofibromatosis 1 1
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Clinical Trial Locations for Dabrafenib Mesylate

Trials by Country

Trials by Country for Dabrafenib Mesylate
Location Trials
United States 12
Korea, Republic of 1
China 1
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Trials by US State

Trials by US State for Dabrafenib Mesylate
Location Trials
Maryland 2
Texas 1
Tennessee 1
Pennsylvania 1
Ohio 1
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Clinical Trial Progress for Dabrafenib Mesylate

Clinical Trial Phase

Clinical Trial Phase for Dabrafenib Mesylate
Clinical Trial Phase Trials
Phase 2 6
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Dabrafenib Mesylate
Clinical Trial Phase Trials
Recruiting 3
Not yet recruiting 2
Active, not recruiting 2
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Clinical Trial Sponsors for Dabrafenib Mesylate

Sponsor Name

Sponsor Name for Dabrafenib Mesylate
Sponsor Trials
National Cancer Institute (NCI) 3
Haining Health-Coming Biotech Co., Ltd. 1
Yonsei University 1
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Sponsor Type

Sponsor Type for Dabrafenib Mesylate
Sponsor Trials
NIH 4
Other 3
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