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

Primary Purpose

Colon Cancer

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant nematode anticoagulant protein c2 (rNAPc2)
Sponsored by
ARCA Biopharma, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • LAC/USC Medical Center

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Safety measured by adverse events
Efficacy measured by new metastasis-free survival by 8 months
Survival by 8 months
Arterial or venous thrombosis
Tumor response rate, as assessed by RECIST criteria

Full Information

First Posted
March 2, 2007
Last Updated
May 5, 2008
Sponsor
ARCA Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00443573
Brief Title
Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
Official Title
Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Suspended
Why Stopped
Company suspended development of product.
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2007 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ARCA Biopharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
recombinant nematode anticoagulant protein c2 (rNAPc2)
Other Intervention Name(s)
anticoagulant
Intervention Description
escalating dose administered 2x/week sq.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety measured by adverse events
Time Frame
30 days after study completion
Title
Efficacy measured by new metastasis-free survival by 8 months
Time Frame
8 months
Title
Survival by 8 months
Time Frame
8 months
Title
Arterial or venous thrombosis
Time Frame
8 months
Title
Tumor response rate, as assessed by RECIST criteria
Time Frame
30 days after study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Love, MD
Organizational Affiliation
ARCA Biopharma, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
LAC/USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nuvelo.com
Description
Company Website

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

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