NCT02697058

Phase II of BAX2398/5-FU/Calcium Levofolinate in Pancreatic Cancer

Phase II Randomized Study of BAX2398 in Combination With 5-Fluorouracil and Calcium Levofolinate in Japanese Patients With Metastatic Pancreatic Cancer, Which Progressed or Recurred After Prior Gemcitabine-Based Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BAX2398 + 5-FU/calcium levofolinate	BAX2398 (a liposomal formulation of irinotecan) in combination with 5-FU/calcium levofolinate
DRUG	5-FU/calcium levofolinate	5-FU/calcium levofolinate alone

Timeline

• Start date: 2016-03-30
• Primary completion: 2017-05-04
• Completion: 2018-08-28
• First posted: 2016-03-03
• Last updated: 2024-07-25

Locations

16 sites across 1 country: Japan