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

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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.

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: recombinant nematode anticoagulant protein c2 (rNAPc2) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
Study Start Date : December 2006
Estimated Primary Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Protein C


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


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety measured by adverse events [ Time Frame: 30 days after study completion ]
  2. Efficacy measured by new metastasis-free survival by 8 months [ Time Frame: 8 months ]
  3. Survival by 8 months [ Time Frame: 8 months ]
  4. Arterial or venous thrombosis [ Time Frame: 8 months ]
  5. Tumor response rate, as assessed by RECIST criteria [ Time Frame: 30 days after study completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443573


Locations
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United States, California
LAC/USC Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
ARCA Biopharma, Inc.
Investigators
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Study Chair: Ted Love, MD ARCA Biopharma, Inc.

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Responsible Party: Ted Love, MD, Nuvelo, Inc.
ClinicalTrials.gov Identifier: NCT00443573     History of Changes
Other Study ID Numbers: NAP-0601
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2008
Keywords provided by ARCA Biopharma, Inc.:
metastatic colorectal carcinoma (mCRC)
colorectal carcinoma (CRC)
tissue factor
factor VIIa
rNAPc2
adenocarcinoma
targeted therapy
coagulation-dependent
RECIST
5-FU-based chemotherapy
FOLFOX
FOLFIRI
leucovorin
XELOX
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Protein C
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action