- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00443573
Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
May 5, 2008 updated by: ARCA Biopharma, Inc.
Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90033
- LAC/USC Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
30 days after study completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety measured by adverse events
Time Frame: 30 days after study completion
|
30 days after study completion
|
Efficacy measured by new metastasis-free survival by 8 months
Time Frame: 8 months
|
8 months
|
Survival by 8 months
Time Frame: 8 months
|
8 months
|
Arterial or venous thrombosis
Time Frame: 8 months
|
8 months
|
Tumor response rate, as assessed by RECIST criteria
Time Frame: 30 days after study completion
|
30 days after study completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ted Love, MD, ARCA Biopharma, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Anticipated)
August 1, 2007
Study Registration Dates
First Submitted
March 2, 2007
First Submitted That Met QC Criteria
March 2, 2007
First Posted (Estimate)
March 6, 2007
Study Record Updates
Last Update Posted (Estimate)
May 7, 2008
Last Update Submitted That Met QC Criteria
May 5, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Protein C
Other Study ID Numbers
- NAP-0601
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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