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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00443573
Recruitment Status : Suspended (Company suspended development of product.)
First Posted : March 6, 2007
Last Update Posted : May 7, 2008
Sponsor:
Information provided by:
ARCA Biopharma, Inc.

Tracking Information
First Submitted Date  ICMJE March 2, 2007
First Posted Date  ICMJE March 6, 2007
Last Update Posted Date May 7, 2008
Study Start Date  ICMJE December 2006
Estimated Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2007)
  • 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)
  • Progression-free (as assessed by RECIST criteria) survival by 8 months
Change History Complete list of historical versions of study NCT00443573 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2007)
  • Safety measured by adverse events
  • New metastasis-free survival by 8 months
  • Survival by 8 months
  • Arterial or venous thrombosis
  • Tumor response rate, as assessed by RECIST criteria
  • CEA (based on central laboratory measurements)
  • Coagulation values; PT, aPTT, INR, prothrombin fragment (F1.2), TAT, TF, and fibrinogen (based on central laboratory measurements)
  • rNAPc2 levels
  • Anti-rNAPc2 antibody development (based on central laboratory measurements)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
Official Title  ICMJE Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE Drug: recombinant nematode anticoagulant protein c2 (rNAPc2)
escalating dose administered 2x/week sq.
Other Name: anticoagulant
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 2, 2007)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00443573
Other Study ID Numbers  ICMJE NAP-0601
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ted Love, MD, Nuvelo, Inc.
Study Sponsor  ICMJE ARCA Biopharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ted Love, MD ARCA Biopharma, Inc.
PRS Account ARCA Biopharma, Inc.
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP