Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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)
30 days after study completion
Yes
Ted Love, MD
Study Chair
ARCA Biopharma, Inc.
United States: Food and Drug Administration
NAP-0601
NCT00443573
December 2006
Name | Location |
---|---|
LAC/USC Medical Center | Los Angeles, California 90033 |