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Clinical Trial 17651
Cancer Type: Gastrointestinal Tumor
Interventions:BAY 73-4506 (Regorafenib); Regorafenib
Study Type: Treatment
Phase of Study: Phase II
Multi Institutional Phase II Trial of Single Agent Regorafenib in Refractory Advanced Biliary Cancers
The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.
Primary Objective: To determine the 6 month overall survival in patients with advanced refractory BC receiving regorafenib. Secondary Objectives: To determine the frequency and severity of adverse events and tolerability of the regimen in patients with advanced refractory BC receiving regorafenib. To evaluate the disease control rate (CR + PR+ SD) as defined by the RECIST 1.1 criteria in patients with advanced refractory biliary cancers (BC) receiving regorafenib at 8 weeks. To determine the progression-free survival in patients with advanced refractory BC receiving regorafenib. Exploratory Objectives: To explore potential correlations between blood biomarkers and clinical outcome.