drugset / Trial / NCT00967616

Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy

NCT00967616

Phase 2 Completed 100 enrolled Daiichi Sankyo
RandomizedParallel-groupOpen-labelTreatment

Summary

This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy will participate in the study, which will be conducted on an outpatient basis. It is anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.

Timeline

Start
2009-09
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject efatutazone Small molecule 0.5 mg Oral
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications