drugset
drugset / Trial / NCT00090025

XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors

NCT00090025 ↗

Phase 3 Terminated 248 enrolled Helsinn Healthcare SA
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2004-09
Primary completion
2006-11
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Leucovorin Small molecule 25 mg/m2 Intravenous
Subject becatecarin Other / unclassified 140 mg/m2 Intravenous
Comparator fluorouracil Small molecule 375 mg/m2 Intravenous

Indications

biliary tract cancer