Company suspended development of product.

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.

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.

• Tissue diagnosis of adenocarcinoma of the colon or rectum
• Documented metastatic disease with at least one measurable lesion by RECIST criteria
• Previously treated with 5-FU-based chemotherapy in the form of FOLFIRI, FOLFOX, or XELOX plus bevacizumab as first-line chemotherapy and have recorded progressive disease during treatment or after discontinuation of treatment, when discontinuation of treatment occurred less than 6 months before enrollment (Stage I) or randomization (Stage II)
• Estimated life expectancy of at least 6 months
• Age 18 to 75 years
• Last dose of adjuvant or radiosensitizing chemotherapy less than 6 months before enrollment
• No other active malignancy for which the subject is currently receiving treatment (other than mCRC)
• No ongoing therapy with or need for parenteral and oral antithrombotics including anticoagulants and anti-platelet agents (including aspirin) and thrombolytics
• No contraindication to systemic anticoagulation
• No contraindication to modified FOLFOX6 or FOLFIRI combination chemotherapy
• No receipt of any investigational compound within 28 days of enrollment