Clinical trial · Interventional
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery
NCT00090025CI-TRIAL-00001898terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Futility reasons after Independent Data Monitoring Committee interim analysis
Summary
Brief summary (as posted)
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.
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 |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil Plus Leucovorin | Drug | — | UNRESOLVED |
| becatecarin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- becatecarin
- description
- becatecarin
- interventionNames
- Drug: becatecarin
- type
- ACTIVE_COMPARATOR
- label
- 5-FU Plus Leucovorin (LV)
- description
- 5-Fluorouracil (5-FU) Plus Leucovorin (LV)
- interventionNames
- Drug: 5-Fluorouracil Plus Leucovorin
Primary outcomes (1)
- measure
- To compare survival duration for XL119 and 5-FU/LV treated subjects
- timeFrame
- time to death
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach * 18 years or older * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3 * Willing and able to sign informed consent * Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide) * Women of child-bearing age must have a negative pregnancy test * Laboratory criteria Exclusion Criteria: * Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study) * Unstable angina, or class III or IV New York Heart Association heart disease * Central nervous system metastases * Uncontrolled diabetes mellitus * Uncontrolled seizure disorder * Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment * Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation * Pregnant or breast-feeding * A known history of human immunodeficiency virus (HIV) infection
References
Publications (0)
Data not yet available
No reference posted for this study.