Phase II of BAX2398/5-FU/Calcium Levofolinate in Pancreatic Cancer
Status:
Completed
Trial end date:
2018-08-28
Target enrollment:
Participant gender:
Summary
Study Part 1: To assess the safety and tolerability, and to characterize the pharmacokinetics
(PK) of BAX2398 in combination with 5-FU/calcium levofolinate in Japanese patients.
Study Part 2: To compare the efficacy of BAX2398 in combination with 5-FU/calcium
levofolinate versus 5-FU/calcium levofolinate as assessed by Progression Free Survival (PFS)
using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
Phase:
Phase 2
Details
Lead Sponsor:
Baxalta US Inc. Institut de Recherches Internationales Servier