Clinical trialPhase 2Completed
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
- Outcome
- Finished, no results posted
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 30 March 2016
- Expected end
- 28 August 2018
- Enrollment
- 84 participants
- Sites
- 16
- Primary outcomes
- Progression Free Survival (PFS) in Part 2 of Study
- Sponsor
- Other
- Results posted
- No
- Last update
- 25 July 2024
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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).
Papers 1
- Registry-listed results papernal-IRI+5-FU/LV versus 5-FU/LV in post-gemcitabine metastatic pancreatic cancer: Randomized phase 2 trial in Japanese p… DOI 10.1002/cam4.3558↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.