Phase 1/2Suspended
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
- Sponsor
- ARCA Biopharma, Inc. (Industry)
- Enrollment
- 100 planned
- Conditions
- Colon Cancer
- Interventions
- recombinant nematode anticoagulant protein c2 (rNAPc2)
- Ages
- adults, older adults
- Registry
- NCT00443573
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Safety measured by major hemorrhage (NCI CTCAE v3.0 grade 3 or greater), during and up to 30 days after completion of study drug administration or, if treatment is ongoing, by 8 months after study enrollment (Stage I) or randomization (Stage II)
History
Last registry update
Primary completion
Registered
Started