drugset / Trial / NCT01347645
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.
Timeline
- Start
- 2011-09-30
- Primary completion
- 2015-06-22
- Completion
- 2015-06-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | E7820 | Small molecule | 40 mg | Oral |
| Comparator | E7820 | Small molecule | 70 mg | Oral |
| Comparator | E7820 | Small molecule | 100 mg | Oral |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 200 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |