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| Sponsored by: |
Helsinn Healthcare SA |
| Information provided by: | Helsinn Healthcare SA |
| ClinicalTrials.gov Identifier: | NCT00090025 |
Purpose
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.
| Condition | Intervention | Phase |
|
Biliary Tract Cancer |
Drug: XL119 Drug: 5-Fluorouracil and Leucovorin |
Phase III |
| Genetics Home Reference related topics: | bladder cancer |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil BMS 181176 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Phase 3 Multicenter, Single-Blind, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery |
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | January 2007 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory criteria (within 72 hours of first XL119 treatment)
Exclusion Criteria:
Contacts and Locations![]() |
Show 59 Study Locations |
| Helsinn Healthcare SA |
More Information
| Study ID Numbers: | XL119-001 |
| First Received: | August 19, 2004 |
| Last Updated: | January 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00090025 |
| Health Authority: | United States: Food and Drug Administration |
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