NCT00671372

A Study of Dulanermin Administered in Combination With Camptosar®/Erbitux® Chemotherapy or FOLFIRI (With or Without Bevacizumab) in Subjects With Previously Treated Metastatic Colorectal Cancer

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Multiple Doses of Dulanermin Administered Intravenously in Combination With Camptosar®/Erbitux® Chemotherapy or the Folfiri Regimen With or Without Bevacizumab in Subjects With Previously Treated Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and pharmacokinetics of adding dulanermin to Camptosar®/Erbitux® or the FOLFIRI regimen (Camptosar®, 5-FU, and leucovorin) plus bevacizumab (only for Cohort 6 subjects who have not received prior bevacizumab therapy).

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	FOLFIRI regimen	Intravenous repeating dose
DRUG	bevacizumab	Intravenous repeating dose (for Cohort 6 subjects not previously treated with bevacizumab)
DRUG	cetuximab	Intravenous repeating dose
DRUG	dulanermin	Intravenous repeating dose
DRUG	irinotecan	Intravenous repeating dose

Timeline

• Start date: 2006-07-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2008-05-05
• Last updated: 2016-11-02

Locations

10 sites across 1 country: United States