S1310 Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer.(S1310)
Primary Objective: a. To assess overall survival (OS) in patients with refractory advanced biliary cancer randomized to Arm 1: trametinib compared to those randomized to Arm 2: Chemotherapy (either 5-fluorouracil and leucovorin or capecitabine). Secondary Objectives: a. To determine the frequency and severity of adverse events of trametinib in this patient population. b. To assess response rate (RR) and progression-free survival (PFS) in patients randomized to Arm 1: trametinib and patients randomized to Arm 2: Chemotherapy (5-FU or capecitabine in this patient population).
KeywordsMEK Inhibitor, Trametinib, Capecitabine, Refractory, Biliary Cancer
Principal InvestigatorThomas J George, M.D.
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