CX-4945-CCA Study Focus CX-4945-CCA Protocol Number S4-13-001 Sponsor Senhwa Biosciences, Inc. Estimated Enrollment 216, for details see the Objectives below Objective Phase I (Dose Escalation Phase/Completed with 51 pts enrolled ) Primary endpoint To determine the combination maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of CX-4945 Secondary endpoint To establish the pharmacokinetic (PK) profile Phase II (Randomized Study Phase/ On-going, estimated recruitment 165 pts) Primary endpoint Comparison of the progression-free survival (PFS) between the test and control arms Secondary endpoint Comparison of the overall-response rate (ORR) between the test and control arms Comparison of the number of patient who transition to surgical resection between the test and control arms Comparison of the overall survival rates (OS) between the test and control arms Link: https://clinicaltrials.gov/ct2/show/NCT02128282?term=CX-4945&rank=1
