Clinical trial · Interventional
S-1 Versus 5-FU Bolus in Metastatic Pancreatic Cancer Patients Previously Treated With Gemcitabine-Based Regimen
A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Following the termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical
Summary
Brief summary (as posted)
The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 5-Fluorouracil
- interventionNames
- Drug: 5-Fluorouracil
- type
- EXPERIMENTAL
- label
- S-1
- interventionNames
- Drug: S-1
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- study period
Secondary outcomes (3)
- measure
- Progression Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas * Metastatic disease previously treated with a gemcitabine-based regimen Exclusion Criteria: * Locally advanced disease * More than one prior chemotherapy-line for advanced pancreatic disease * Prior treatment with fluoropyrimidines for advanced pancreatic cancer * Eastern Cooperative Oncology Group (ECOG) performance status \>or= 2 * Poor kidney, liver or bone marrow functions * Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study * Unable to swallow capsules * Hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines * Concurrent participation in another clinical trial or treatment with any other anticancer therapy The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available