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

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCA Biopharma, Inc.
• Treatments: Anticoagulants; Protein C

Criteria

• 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