NCT00443573

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

Enrollment Period

8 months

First QC Date

March 2, 2007

Last Update Submit

May 5, 2008

Conditions

Colon Cancer

Keywords

metastatic colorectal carcinoma (mCRC)colorectal carcinoma (CRC)tissue factorfactor VIIarNAPc2adenocarcinomatargeted therapycoagulation-dependentRECIST5-FU-based chemotherapyFOLFOXFOLFIRIleucovorinXELOX

Outcome Measures

Primary Outcomes (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)

    30 days after study completion

Secondary Outcomes (5)

  • Safety measured by adverse events

    30 days after study completion

  • Efficacy measured by new metastasis-free survival by 8 months

    8 months

  • Survival by 8 months

    8 months

  • Arterial or venous thrombosis

    8 months

  • Tumor response rate, as assessed by RECIST criteria

    30 days after study completion

Interventions

recombinant nematode anticoagulant protein c2 (rNAPc2)DRUG

escalating dose administered 2x/week sq.

Also known as: anticoagulant

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

LAC/USC Medical Center

Los Angeles, California, 90033, United States

Location

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsAdenocarcinoma

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Ted Love, MD

    ARCA Biopharma, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

December 1, 2006

Primary Completion

August 1, 2007

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

US(1)