drugset / Trial / NCT00967616
Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |