Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
NCT ID: NCT00443573
Last Updated: 2008-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Interventions
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recombinant nematode anticoagulant protein c2 (rNAPc2)
escalating dose administered 2x/week sq.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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ARCA Biopharma, Inc.
INDUSTRY
Responsible Party
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Nuvelo, Inc.
Principal Investigators
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Ted Love, MD
Role: STUDY_CHAIR
ARCA Biopharma, Inc.
Locations
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LAC/USC Medical Center
Los Angeles, California, United States
Countries
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Related Links
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Company Website
Other Identifiers
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NAP-0601
Identifier Type: -
Identifier Source: org_study_id
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