NCT00483080

Study of NGR-hTNF as Single Agent in Patients Affected by Colorectal Cancer (CRC)

NGR006: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Colorectal Cancer (CRC), Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan Based Regimens

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: AGC Biologics S.p.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic colorectal cancer patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Detailed description

This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic colorectal cancer (CRC), previously treated with fluoropyrimidine, oxaliplatin and irinotecan based regimens, that will be conducted using Simon's two-stage design method.

Conditions

• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
DRUG	NGR-hTNF	iv q3W or q1W NGR-hTNF 0.8 μg/m²

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-06-01
• Completion: 2013-04-01
• First posted: 2007-06-06
• Last updated: 2019-01-16

Locations

3 sites across 1 country: Italy