Clinical trialPhase 3Completed
Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma
A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma
- Outcome
- Outcome unknown
- Phase
- Phase 3
- Status
- Completed
- Study type
- Interventional
- Start
- 23 May 2019
- Expected end
- 26 April 2022
- Enrollment
- 211 participants
- Sites
- 26
- Primary outcomes
- Overall Survival
- Sponsor
- Other
- Results posted
- 2026-01-15
- Last update
- 15 January 2026
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Brief summary public domain (ClinicalTrials.gov)
This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival [Until death (life expectancy around 12 months)]. Median, months (95% Confidence Interval). GEMPAX (n=140): 6.4 (5.2 to 7.4); Control (n=71): 5.9 (4.6 to 6.9).