At a glance
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A Randomized Two-Arm Phase II Study of Trametinib Alone and in Combination With GSK2141795 in Patients With Advanced Uveal Melanoma
In Brief
A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Pharmacological Study, and 2 other interventions for Recurrent Uveal Melanoma and Stage IV Uveal Melanoma AJCC v7. Active but no longer recruiting, targeting 42 participants across 7 sites in 3 countries.
Signals
Detailed Summary
This randomized phase II trial studies how well trametinib with or without Akt inhibitor GSK2141795 (GSK2141795) works in treating patients with uveal melanoma that has spread to other parts of the body (metastatic). Trametinib and GSK2141795 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective with or without GSK2141795 in treating patients with metastatic uveal melanoma.
Study Details
Timeline
Arms & Interventions
Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Correlative studies
Correlative studies
Given PO
Given PO