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

Colon Cancer Clinical Trial

Official title:

Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00443573
• Other study ID #: NAP-0601
• Status: Suspended
• Phase: Phase 1/Phase 2
• First received: March 2, 2007
• Last updated: May 5, 2008
• Start date: December 2006

Study information

• Verified date: May 2008
• Source: ARCA Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Drug:
• recombinant nematode anticoagulant protein c2 (rNAPc2)
escalating dose administered 2x/week sq.

Locations

Country	Name	City	State
United States	LAC/USC Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
ARCA Biopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Safety measured by adverse events		30 days after study completion	Yes
Secondary	Efficacy measured by new metastasis-free survival by 8 months		8 months	Yes
Secondary	Survival by 8 months		8 months	Yes
Secondary	Arterial or venous thrombosis		8 months	Yes
Secondary	Tumor response rate, as assessed by RECIST criteria		30 days after study completion	Yes