Colon CancerPhase 1/2NCT00443573
Safety Study of Recombinant NAPc2 to Prevent Tumor Progression and Metastases in Metastatic Colon Cancer
A Phase 1/2 study testing recombinant nematode anticoagulant protein c2 (rNAPc2) in people with Colon Cancer, run by ARCA Biopharma, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- recombinant nematode anticoagulant protein c2 (rNAPc2)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Aug 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC/USC Medical Center
Los Angeles, California, 90033
About this study
Official title: 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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- recombinant nematode anticoagulant protein c2 (rNAPc2)
- 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
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant nematode anticoagulant protein c2 (rNAPc2)Drug
Also called anticoagulant
escalating dose administered 2x/week sq.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days after study completion
Secondary outcomes (5)
Safety measured by adverse events
Measured: 30 days after study completion
Efficacy measured by new metastasis-free survival by 8 months
Measured: 8 months
Survival by 8 months
Measured: 8 months
Arterial or venous thrombosis
Measured: 8 months
Tumor response rate, as assessed by RECIST criteria
Measured: 30 days after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startDec 2006
- Primary completionAug 2007 (estimated)
Why it stopped: Company suspended development of product.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCA Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ted Love, MD, Study chair, ARCA Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443573
- Sponsor's protocol ID
- NAP-0601
- Status last verified
- May 2008
- First submitted
- 2 Mar 2007
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Two-Stage Study to Evaluate the Safety and Efficacy of Second-Line Metastatic Colorectal Carcinoma Treatment With Recombinant NAPc2
- ClinicalTrials.gov ID
- NCT00443573
- Acronym / sponsor ID
- NAP-0601
- Conditions
- Colon Cancer
- Keywords
- metastatic colorectal carcinoma (mCRC), colorectal carcinoma (CRC), tissue factor, factor VIIa, rNAPc2, adenocarcinoma, targeted therapy, coagulation-dependent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Company suspended development of product.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ARCA Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (estimated)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant nematode anticoagulant protein c2 (rNAPc2)Also: anticoagulantescalating dose administered 2x/week sq. | Drug | – |
Primary outcome
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
5 secondary outcomes
Safety measured by adverse events
Time frame: 30 days after study completion
Efficacy measured by new metastasis-free survival by 8 months
Time frame: 8 months
Survival by 8 months
Time frame: 8 months
Arterial or venous thrombosis
Time frame: 8 months
Tumor response rate, as assessed by RECIST criteria
Time frame: 30 days after study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
- Company WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted Love, MD study chair
ARCA Biopharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing recombinant nematode anticoagulant protein c2 (rNAPc2) in people with Colon Cancer, run by ARCA Biopharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2008.