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.
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
Ted Love, MD
ARCA Biopharma, Inc.
United States: Food and Drug Administration
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