A Phase 1/2 interventional study of recombinant nematode anticoagulant protein c2 (rNAPc2) in Colon Cancer, sponsored by ARCA Biopharma, Inc.. Suspended at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-05-07.
Sponsored by ARCA Biopharma, Inc. · Phase 1/2, Interventional, and Treatment
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 100 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →ARCA Biopharma, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
escalating dose administered 2x/week sq.
Also known as: anticoagulant
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)
Time frame: 30 days after study completion
Safety measured by adverse events
Time frame: 30 days after study completion
Efficacy measured by new metastasis-free survival by 8 months
Time frame: 8 months
Survival by 8 months
Time frame: 8 months
Arterial or venous thrombosis
Time frame: 8 months
Tumor response rate, as assessed by RECIST criteria
Time frame: 30 days after study completion
This study is suspended, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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ARCA Biopharma, Inc.