NCT00675012

NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

NGR005: Pilot Study of NGR-hTNF Administered at Low and High Doses in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AGC Biologics S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments

Detailed description

Phase II, open-label, non-randomized study that will be conducted in two sequential cohorts of patients. Patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments are planned to be enrolled.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	NGR-hTNF	iv 0.8 or 45 mcg/sqm q3W
DRUG	Oxaliplatin	iv q3W 100 mg/sqm 60 minutes after NGR-hTNF infusion
DRUG	capecitabine	orally 825 mg/sqm 2qDx14

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-12-01
• Completion: 2013-05-01
• First posted: 2008-05-08
• Last updated: 2014-05-30

Locations

1 site across 1 country: Italy