Clinical trial · Interventional
Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen
A Randomized, Open Label Multi-Center Study Of Single Agent Larotaxel (XRP9881) Compared To Continuous Administration of 5-FU For The Treatment Of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Larotaxel (XRP9881) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Larotaxel (XRP9881)
- interventionNames
- Drug: Larotaxel (XRP9881)
- type
- ACTIVE_COMPARATOR
- label
- 5-Fluorouracil or capecitabine
- description
- Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.
- interventionNames
- Drug: 5-Fluorouracil
- Drug: Capecitabine
Primary outcomes (1)
- measure
- overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas. * Patient must be previously treated with a systemic gemcitabine based regimen * Adequate bone marrow, kidney and liver functions Exclusion Criteria: * ECOG performance status (PS) of 2-3-4. * Prior locoregional radiotherapy for pancreatic cancer. * Symptomatic brain metastases or leptomeningeal disease. * Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases. * Other concurrent malignancy * Other protocol-defined exclusion/inclusion criteria may apply
References
Publications (0)
Data not yet available