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Mekinist (Trametinib Dimethyl Sulfoxide) - Summary



Trametinib dimethyl sulfoxide is a kinase inhibitor.

MEKINIST® as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [see Clinical Studies].

MEKINIST, in combination with dabrafenib, is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. This indication is based on the demonstration of durable response rate [see Clinical Studies]. Improvement in disease-related symptoms or overall survival has not been demonstrated for MEKINIST in combination with dabrafenib.

Limitation of use: MEKINIST as a single agent is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy [see Clinical Studies].

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Published Studies Related to Mekinist (Trametinib)

Improved overall survival in melanoma with combined dabrafenib and trametinib. [2015]
of patients... CONCLUSIONS: Dabrafenib plus trametinib, as compared with vemurafenib

Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: quality-of-life analyses of the METRIC study. [2014]
patients with BRAF V600 mutation-positive melanoma... CONCLUSIONS: This first QOL assessment for a MEK inhibitor in metastatic melanoma

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Clinical Trials Related to Mekinist (Trametinib)

A Comparative Study Efficacy of Trametinib (CT) in Comparison With Trametinib (MEKINIST) [Active, not recruiting]

Study for the Evaluation Dabrafenib (Tafinlar) and Trametinib (Mekinist) Plus DNE3 in Patients With Metastatic Melanoma [Terminated]
Previous studies have shown that combination of a BRAF inhibitor (dabrafenib) with MEK inhibitor (trametinib) and exhibit synergistic effects on tumor cells (melanoma), together with Akt inhibitors. But the major drawbacks of many effective cancer chemotherapeutic agents are systemic toxicity and drug resistance. In this regard , phytotherapeutic agent DNE3 (PI3K-Akt inhibitor) with high anticancer activity and less toxicity to normal tissues has been suggested as possible candidates for their capability to improve the efficacy of anticancer drugs Dabrafenib and Trametinib.

GSK1120212 in Surgically Resectable Oral Cavity Squamous Cell Cancer [Active, not recruiting]
This phase II trial studies how trametinib effects tumor cells in patients with oral cavity squamous cell carcinoma that can be removed by surgery. Trametinib may shrink the tumor by blocking an enzyme pathway needed for cell growth.

A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor Malignancies [Completed]
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.

Trametinib in Treating Patients With Advanced Cancer With or Without Hepatic Dysfunction [Recruiting]
This phase I trial studies the side effects and best dose of trametinib in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) with or without liver (hepatic) dysfunction. Trametinib may stop the growth of tumor cells by blocking proteins needed for cell growth. When these proteins are blocked, the growth of cancer cells may be stopped and the cancer cells will then die. Hepatic dysfunction is frequently found in patients with advanced cancer and usually prevents patients from receiving standard treatments or from participating in clinical trials. Patients may also need dose adjustments or absorb drugs differently. Trametinib may be a better treatment for patients with advanced cancers and hepatic dysfunction.

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Page last updated: 2015-08-10

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