Angina PectorisPhase 2NCT00093223
A Safety Study of ABI-007 for In-Stent Restenosis
A Phase 2 study testing Paclitaxel Nanoparticle Albumin Bound in people with Angina Pectoris and Coronary Artery Disease, run by Celgene at 1 site in United States.
Trial summary
This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Coronary Artery Disease
- What is being tested?
- Paclitaxel Nanoparticle Albumin Bound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2001to 1 Dec 2007
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries
- Diagnosis of angina pectoris
- At least 18 yrs old
- If female, negative pregnancy test, non-lactating, and agree to utilize methods to prevent pregnancy
- No previous treatment for In-Stent Restenosis
- Patient agrees to comply with follow-up evaluation
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- Informed Consent obtained
- Target vessel at least 3 mm diameter
- Total stent less than 25 mm
- Left ventricular ejection fraction at least 30%
- No more than a single stent will be used per lesion
- No more than one stented lesion per vessel with the exception that 2 lesions in a single vessel are allowable if covered by less than 25 mm of continuous stent
- By Intravascular Ultrasound (IVUS), stent is fully opposed and has a minimum diameter of 3 mm or an in-stent luminal area of at least 7 mm2
- TIMI 3 coronary flow post-stenting
- No angiographic evidence of thrombus post-stenting
- General Exclusion Criteria:
- More than two lesions treated with Percutaneous Coronary Intervention (PCI) or it is anticipated that additional lesions will require treatment within two months
- Previous PCI within preceding three months
- Previous participation in another study within 30 days
- Life expectancy less than 12 months
- Factors making follow-up difficult
- Intended surgical intervention within 6 months of study participation
- Investigator decision that patient is unsuitable
- Recipient of heart transplant
- Q wave or non-Q wave Myocardial Infarction (MI) with documented total CK greater than 2X normal upper limits within the preceding 24 hrs and the CK and CK-MB enzymes remain above normal at the time of the procedure
- Cardiogenic shock
- May refuse blood transfusion
- Gastro-intestinal bleeding within past 3 months
- Platelet count less than 100,000 cells/mm3
- Impaired renal function
- Known allergies/hypersensitivity to aspirin, clopidogrel bisulfate, and/or stainless steel
Who cannot join
- Intervention for another lesion occurred within 90 days or is planned for within 60 days after the index procedure
- Stent is located in a coronary bypass
- Unprotected left main disease with greater than 50% stenosis
- Lost a side branch greater than 2 mm during stenting procedure
- Angiographic evidence of thrombus post-stenting
- Prior stent within 5 mm of target lesion
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- Left ventricular ejection fraction less than 30%
- Greater than 50% stenosis proximal or distal to target lesion
- Malposition, dissection, or unmasking of a significant narrowing in the inflow or outflow area of the implanted stent
- Patient has received a drug coated stent as part of this procedure
- Absolute neutrophil count is less than 1500 cells/mm3
- Platelet count is less than 100,000 cells/mm3
- Bilirubin greater than 1.5 mg/dl or SGOT and SGPT greater than 2.5X upper limit of normal or alkaline phosphatase greater than 2.5X upper limit of normal
- Creatinine greater than 2.5X upper limit normal
- Pre-existing peripheral neuropathy of NCI toxicity Criteria Scale of Grade greater than 1
- Immunosuppressed or has HIV or AIDS
- Hypersensitivity to Taxane
Trial locations and contacts
1 site in 1 country.
United States1 site
Abraxis BioScience, Inc.
Durham, North Carolina, 27703
About this study
Official title: A Phase II Safety Study of Systemic Nanoparticle Paclitaxel (ABI-007)for In-Stent Restenosis
This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries. The purpose of the trial is to determine the appropriate dose of the new medicine for future trials and to evaluate the incidence of treatment-emergent adverse events and serious adverse events.
Read the detailed description
See inclusion/exclusion criteria.
- Conditions
- Angina Pectoris, Coronary Artery Disease
- Being tested
- Paclitaxel Nanoparticle Albumin Bound
- Keywords
- In-Stent Restenosis
- Medical subject headings
- Angina Pectoris, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Nanoparticle Albumin BoundDrug
Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s).
Paclitaxel Nanoparticle Albumin BoundDrug
Paclitaxel Nanoparticle Albumin BoundDrug
35mg/35 infusion time is 3.5 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 35mg/m^2 infusion time is 3.5 minutes Receives: Drug: Paclitaxel Nanoparticle Albumin Bound |
| 2 | Experimental | 2 doses of 35mg.m^2 with the second dose given 2 months later Receives: Drug: Paclitaxel Nanoparticle Albumin Bound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events and serious adverse events.
Measured: 6 months
Major Adverse Cardiac Events at 2 months following the stent procedure.
Measured: 2 months
Safety and tolerability for ABI-007
Measured: 2 Years
Secondary outcomes (1)
Evaluation of restenosis at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2004 (estimated)
- Study start1 Sep 2001
- Primary completion1 Dec 2007
- Study completion1 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Iglesias, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093223
- Sponsor's protocol ID
- CVR001
- Status last verified
- Nov 2019
- First submitted
- 4 Oct 2004
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety Study of Systemic Nanoparticle Paclitaxel (ABI-007)for In-Stent Restenosis
- ClinicalTrials.gov ID
- NCT00093223
- Acronym / sponsor ID
- CVR001
- Conditions
- Angina Pectoris, Coronary Artery Disease
- Keywords
- In-Stent Restenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2001 (actual)
- Primary completion
- 1 Dec 2007 (actual)
- Study completion
- 1 Dec 2007 (actual)
- First posted
- 7 Oct 2004 (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 trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries. The purpose of the trial is to determine the appropriate dose of the new medicine for future trials and to evaluate the incidence of treatment-emergent adverse events and serious adverse events.
Detailed description
See inclusion/exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Paclitaxel Nanoparticle Albumin Bound35mg/m^2 infusion time is 3.5 minutes |
| 2 | Experimental | Drug: Paclitaxel Nanoparticle Albumin Bound2 doses of 35mg.m^2 with the second dose given 2 months later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries
- Diagnosis of angina pectoris
- At least 18 yrs old
- If female, negative pregnancy test, non-lactating, and agree to utilize methods to prevent pregnancy
- No previous treatment for In-Stent Restenosis
Key exclusion criteria (17 listed)
- Intervention for another lesion occurred within 90 days or is planned for within 60 days after the index procedure
- Stent is located in a coronary bypass
- Unprotected left main disease with greater than 50% stenosis
- Lost a side branch greater than 2 mm during stenting procedure
- Angiographic evidence of thrombus post-stenting
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 |
|---|---|---|
| Paclitaxel Nanoparticle Albumin BoundSingle or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s). | Drug | 1, 2 |
| Paclitaxel Nanoparticle Albumin Bound | Drug | 1 |
| Paclitaxel Nanoparticle Albumin Bound35mg/35 infusion time is 3.5 minutes | Drug | 2 |
Primary outcome
Incidence of treatment-emergent adverse events and serious adverse events.
Time frame: 6 months
Major Adverse Cardiac Events at 2 months following the stent procedure.
Time frame: 2 months
Safety and tolerability for ABI-007
Time frame: 2 Years
1 secondary outcome
Evaluation of restenosis at 6 months.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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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.
José Iglesias, MD study director
Celgene Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel Nanoparticle Albumin Bound in people with Angina Pectoris and Coronary Artery Disease, run by Celgene 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?
The sponsor lists 31 inclusion and 17 exclusion criteria. 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: finished, as of the sponsor's last update on 18 Nov 2019. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent adverse events and serious adverse events. (time frame: 6 months). The study lists 3 primary outcomes in all. 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 18 Nov 2019.