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

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Colon Cancer

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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recombinant nematode anticoagulant protein c2 (rNAPc2)

escalating dose administered 2x/week sq.

Intervention Type DRUG

Other Intervention Names

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anticoagulant

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Site Status

Countries

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United States

Other Identifiers

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NAP-0601

Identifier Type: -

Identifier Source: org_study_id