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)

A Phase Ib, Dose-Escalation Study of the Safety and Pharmacokinetics of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab	(Only for patients not previously treated with bevacizumab) Intravenous repeating dose
DRUG	cetuximab	Intravenous repeating dose
DRUG	FOLFIRI regimen	Intravenous repeating dose
DRUG	irinotecan	Intravenous repeating dose
DRUG	PRO95780	Intravenous repeating dose

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-07-06
• Last updated: 2017-05-19