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Protocol Summaries: trametinib

GSK
Study ID
   Phase    Title Status
112110 phase 1 An Open-Label, Dose-Escalation, Phase IB II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor GSK1120212 in Combination with Oral Everolimus in Subjects with Solid Tumors Completed
112111 phase 1 A Phase IB Combination Study of MEK inhibitor GSK1120212 with Gemcitabine in Subjects with Solid Tumors Completed
113486 phase 1 An Open-Label, Phase I/Ib Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in Combination with Docetaxel, Erlotinib, Pemetrexed, Pemetrexed + Carboplatin, Pemetrexed + Cisplatin, or nab-Paclitaxel in Subjects with Advanced Solid Tumors Active not recruiting
113487 phase 2 A Randomized, Double-Blind Placebo-Controlled Phase II Study of the MEK inhibitor GSK1120212 plus Gemcitabine vs Placebo plus Gemcitabine in Subjects with Metastatic Pancreatic Cancer Completed
113583 phase 2 An Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in BRAF Mutation-positive Melanoma Subjects Previously Treated with or without a BRAF Inhibitor Completed
113708 phase 1 An Open-label mass balance study to investigate the Absorption, Distribution, Metabolism and Elimination of a Single Oral Dose of MEK inhibitor [14C]GSK1120212 in Male Subjects with Solid Tumors Completed
113709 phase 1 An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of the MEK Inhibitor, GSK1120212, in Subjects with Solid Tumors Completed
114267 phase 3 A Phase III randomized, open-label study comparing GSK1120212 to chemotherapy in subjects with advanced or metastatic BRAF V600E/K mutation-positive melanoma Active not recruiting
114375 phase 2 MEK114375: A Rollover Study to Provide Continued Treatment with GSK1120212 to Subjects with Solid Tumors and Leukemia Recruiting
114655 phase 1 A Phase I, Single-Sequence, Placebo-Controlled, Single-Blind Study to Evaluate the Effect of Repeat Oral Dosing of GSK1120212 on Cardiac Repolarization in Subjects with Solid Tumors Recruiting
114656 phase 1 An Open-label, Randomized, 2-treatment, 2-period, 2-way Crossover, Single-dose Study to Determine the Relative Bioavailability of the MEK inhibitor, Trametinib, in Subjects with Solid Tumor Malignancies Recruiting
114784 phase 1 A Phase I Trial of GSK1120212 and GSK1120212 in Combination with Gemcitabine in Japanese Subjects with Solid Tumors Active not recruiting
115064 phase 1 Determination of the Absolute Bioavailability of GSK1120212 Following a Single Oral Dose Co-Administered with an Intravenous Radiolabelled Microdose of GSK1120212 in Subjects with solid Tumors Completed
115306 phase 3 A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma Active not recruiting
115892 phase 1 An Open-Label, Two-Period, Randomized, Crossover Study to Assess the Relative Bioavailability of GSK1120212 Tablet Formulation and the GSK1120212 Pediatric Oral Solution Formulation Following Single-Dose Administration to Adult Subjects with Solid Tumors Completed
116513 phase 3 A phase III, randomised, open-label study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to the BRAF inhibitor vemurafenib in subjects with unresectable (stage IIIc) or metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma Recruiting
116833 phase 2 An Open-Label, Three-Part, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212, BRAF Inhibitor GSK2118436 and the anti-EGFR Antibody Panitumumab in Combination in Subjects with BRAF-mutation V600E or V600K Positive Colorectal Cancer Recruiting
117254 Systematic review and quantitative analysis of dabrafenib and trametinib therapies in the treatment of metastatic malignant melanoma Active not recruiting
117385 phase 3 Adjusting for treatment crossover in the BREAK-3 and METRIC trials Active not recruiting
MEK111054 phase 1 An Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the MEK Inhibitor GSK1120212 in Subjects with Solid Tumors or Lymphoma Completed