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Generated: September 19, 2018

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CLINICAL TRIALS PROFILE FOR TRAMETINIB DIMETHYL SULFOXIDE

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Clinical Trials for trametinib dimethyl sulfoxide

Trial ID Title Status Sponsor Phase Summary
NCT01725100 A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies Completed GlaxoSmithKline Phase 1 This is an open-label, randomized, single-dose, 2-treatment, 2-period, 2-way crossover study with incomplete wash-out in subjects with solid tumors to determine the relative bioavailability of test formulation with lower dimethyl sulfoxide (DMSO) content as compared with standard reference formulation trametinib. Approximately 18 subjects will be randomized to receive either a single dose of Treatment A (standard target DMSO content [theoretical 11.3%] formulation of GSK1120212B) or a single dose of Treatment B (lower DMSO Content [approximately 9.5%] formulation of GSK1120212B) followed by a 7 day incomplete wash-out period, then a single dose of the other treatment. Administration of the dose under fasted conditions in Periods 1 and 2 will be only on Day 1 followed by 7 days of serial blood sampling for PK analysis of plasma trametinib. Safety assessments, including assessment of AEs, clinical laboratory (hematology and clinical chemistry) and vital signs, will be made throughout the study. After a subject completes the study, he or she may be eligible to enter study MEK114375, an open-label rollover study of trametinib (no wash-out period or follow-up visit required) and continue receiving trametinib. For those subjects who wish to discontinue or complete the current study and choose not enter the rollover study, a follow-up visit should be performed within 21 days after receiving the last dose of study treatment.
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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for trametinib dimethyl sulfoxide

Condition Name

Condition Name for trametinib dimethyl sulfoxide
Intervention Trials
Cancer 1
BRAF V600E Mutation 1
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Condition MeSH

Condition MeSH for trametinib dimethyl sulfoxide
Intervention Trials
Erdheim-Chester Disease 1
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Clinical Trial Locations for trametinib dimethyl sulfoxide

Trials by Country

Trials by Country for trametinib dimethyl sulfoxide
Location Trials
United States 4
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Trials by US State

Trials by US State for trametinib dimethyl sulfoxide
Location Trials
Maryland 1
Tennessee 1
Florida 1
Arizona 1
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Clinical Trial Progress for trametinib dimethyl sulfoxide

Clinical Trial Phase

Clinical Trial Phase for trametinib dimethyl sulfoxide
Clinical Trial Phase Trials
Phase 2 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for trametinib dimethyl sulfoxide
Clinical Trial Phase Trials
Completed 1
Recruiting 1
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Clinical Trial Sponsors for trametinib dimethyl sulfoxide

Sponsor Name

Sponsor Name for trametinib dimethyl sulfoxide
Sponsor Trials
National Human Genome Research Institute (NHGRI) 1
GlaxoSmithKline 1
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Sponsor Type

Sponsor Type for trametinib dimethyl sulfoxide
Sponsor Trials
NIH 1
Industry 1
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Harvard Business School
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