NCT00443573

Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer

Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: ARCA Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, two-stage trial with the goal of evaluating up to 100 subjects. This trial will be performed to initiate identification of a safe and effective dose of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of metastatic colorectal carcinoma in combination with contemporary 5-FU-based chemotherapy.

Detailed description

Cytotoxic chemotherapy combining 5-fluorouracil and leucovorin with irinotecan (FOLFIRI) or oxaliplatin (FOLFOX) or, more recently, treatment with XELOX (Roche) (capecitabine + oxaliplatin) has been the main approach for the treatment of metastatic colorectal carcinoma (mCRC), but with the advent of targeted therapies, biologic treatments are becoming an area of intense interest. Tissue factor (TF) is a transmembrane glycoprotein expressed by upwards of 85% of mCRCs.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	recombinant nematode anticoagulant protein c2 (rNAPc2)	escalating dose administered 2x/week sq.

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-08-01
• First posted: 2007-03-06
• Last updated: 2008-05-07

Locations

1 site across 1 country: United States