drugset / Trial / NCT00780169

Phase I Trial of Sorafenib + FOLFIRI In Metastatic Colorectal Cancer

NCT00780169 ↗

Phase 1 Completed 16 enrolled Ottawa Hospital Research Institute Bayer · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety, the maximum tolerated dose and the recommended dose for phase II studies of a chemotherapy-combination of sorafenib, irinotecan, and 5-fluorouracil (5-FU)/folinic acid (FA) (FOLFIRI) as first-line treatment for metastatic colorectal cancer.

Timeline

Start
2008-10
Primary completion
2011-05
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 80 mg/m2 —
Subject Sorafenib Small molecule 400 mg Oral
Background Leucovorin Small molecule — —
Background fluorouracil Small molecule — —

Indications