drugset / Trial / NCT01274624
Study of REOLYSIN® in Combination With FOLFIRI and Bevacizumab in FOLFIRI Naive Patients With KRAS Mutant Metastatic Colorectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1 dose-escalation study with three dose levels to determine the maximum tolerated dose of REOLYSIN® combined with FOLFIRI and bevacizumab.
Timeline
- Start
- 2010-12
- Primary completion
- 2018-02
- Completion
- 2018-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | REOLYSIN® | Other / unclassified | — | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Background | Fluorouracil (5-FU) | Unknown | 2400 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |