drugset / Trial / NCT00497497
A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)
Non-randomizedCrossoverOpen-labelTreatment
Summary
This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.
Timeline
- Start
- 2007-10
- Primary completion
- 2010-09
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PRO95780 | Unknown | — | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Background | Cetuximab | Monoclonal antibody | — | Intravenous |
| Background | Irinotecan | Small molecule | — | Intravenous |