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Coronary RestenosisPhase 1/2SNAPIST-IIINCT00124943

Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

A Phase 1/2 study testing Nanoparticle Paclitaxel in people with Coronary Restenosis, run by Celgene Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Restenosis
What is being tested?
Nanoparticle Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
No sites listed yet
Study dates
Jul 2005to Aug 2009
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Male or non-pregnant and non-lactating female, and ≥ 18 years of age.
  • Diagnosis of angina pectoris or unstable angina pectoris or patients with documented silent ischemia.
  • Left ventricular ejection fraction ≥30%
  • Patient has undergone successful and uncomplicated stenting of up to 2 de novo lesions in native coronary arteries OR patient has undergone successful and uncomplicated balloon angioplasty of up to 2 in-stent restenosis (ISR) lesions in native coronary arteries, but not both.
  • Thrombolysis In Myocardial Infarction (TIMI) 3 coronary flow post-stenting for de novo lesions or post balloon angioplasty for ISR lesions.
  • No angiographic evidence of thrombus post-procedure.
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  • Target vessel ≥2.5 mm diameter (by angiography).
  • Each de novo lesion is such that it is stented with ≤ 25 mm of single continuous stent.
  • Each in-stent restenosis (ISR) lesion is ≤ 25 mm in length.
  • There is at least 5 mm of non-diseased vessel on either side of target lesion(s).
  • By intravascular ultrasound (IVUS), stent is fully opposed and has a minimum diameter of 2.5 mm or an in-stent luminal area ≥ 5.0 mm^2
  • Patient or guardian has provided a signed written informed consent to participate in the study and in all follow-up assessments using a form that is approved by the local Institutional Review Board (IRB)/Ethics Committee of the investigative site.

Who cannot join

  • Target de novo lesion was treated with a drug-eluting stent
  • Target ISR lesion requires any treatment other than balloon angioplasty
  • Patient has both a de novo lesion and an ISR lesion.
  • If more than 2 lesions are treated with percutaneous coronary intervention (PCI), or it is anticipated that additional lesions will require treatment within 2 months.
  • Previous PCI within preceding two months.
  • Intended surgical intervention within 6 months of enrollment in the study.
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  • Unprotected left main disease with >50% stenosis
  • Malapposition, dissection, or unmasking of a significant narrowing in the inflow or outflow area of the implanted stent.
  • Women who are pregnant and women of child bearing potential who do not use adequate contraception
  • Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational drug or device trial.
  • Patient has a life expectancy of less than 12 months or there are factors making clinical and/or angiographic follow-up difficult
  • Any significant medical condition which, in the investigator's opinion, may interfere with the patient's optimal participation in the study
  • Heart transplant candidate or recipient
  • Patient is immunosuppressed or is HIV positive.
  • Patient has experienced a Q wave or a non Q wave myocardial infarction (MI) with documented total creatine kinase (CK) ≥2 times normal within the preceding 24 hours and the CK and creatine kinase-MB fraction (CK-MB) enzymes remain above normal at the time of the procedure.
  • Cardiogenic shock: sustained systolic blood pressure (SBP) less than 80 mmHg, with no response to fluids or SBP less than 100 mmHg with vasopressors (in absence of bradycardia)
  • Any individual who may refuse a blood transfusion
  • Documented major gastro-intestinal bleeding within 3 months
  • The following lab values at baseline are exclusionary:
  • Serum creatinine > 2.5 mg/dl;
  • Platelet count < 150,000 cells/mm^3;
  • Absolute neutrophil count (ANC) < 2000 cells/mm^3;
  • Hemoglobin (HGB) <9 g/dl;
  • Total bilirubin >1.5 mg/dl;
  • Alanine Aminotransferase (SGPT) > 2.5 x upper limit of normal range (ULN);
  • Aspartate Aminotransferase (SGOT) > 2.5 x ULN;
  • Alkaline phosphatase > 2.5 x ULN.
  • Known allergy/hypersensitivity/contraindication to the study drug; to any taxanes; or to any required study treatment: aspirin, clopidogrel bisulfate, stent materials
  • Pre-existing peripheral neuropathy of National Cancer Institute (NCI) Toxicity Grade > 1.

About this study

Official title: A Phase I/II Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.

Read the detailed description

This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy. Nanoparticle paclitaxel was administered by intracoronary catheter following either successful and uncomplicated stenting of de novo lesions in native coronary arteries or following successful and uncomplicated balloon angioplasty of instent restenosis (ISR) lesions.

Being tested
Nanoparticle Paclitaxel
Keywords
Prevention of Instent Restenosis
Medical subject headings
Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nanoparticle PaclitaxelDrug

    Also called ABI-007, Abraxane®, Coroxane™

    Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.

Study groups in NCT00124943
Study groupRoleWhat they receive
10 mg/m^2 nanoparticle paclitaxelExperimentalParticipants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
Receives: Drug: Nanoparticle Paclitaxel
22 mg/m^2 nanoparticle paclitaxelExperimentalParticipants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
Receives: Drug: Nanoparticle Paclitaxel
35 mg/m^2 nanoparticle paclitaxelExperimentalParticipants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
Receives: Drug: Nanoparticle Paclitaxel
45 mg/m^2 nanoparticle paclitaxelExperimentalParticipants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
Receives: Drug: Nanoparticle Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Number of Participants With Dose-limiting Toxicities

    Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting.

    The maximum tolerated dose was defined as the lesser of 45 mg/m^2 or the dose at which any drug related toxicities were observed.

    Measured: Up to 1 week following percutaneous coronary intervention.

  2. Number of Participants With Procedural Complications

    Procedural complications include the following:

    1. Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes;
    2. Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia;
    3. Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema;
    4. Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow;
    5. Clinical changes: chest pain.

    Measured: From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).

  3. Number of Participants With Treatment Emergent Adverse Events (AEs)

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

    An SAE is any event that:

    • is fatal or life threatening
    • results in persistent or significant disability or or incapacity;
    • requires or prolongs existing hospitalization;
    • is a congenital anomaly/birth defect in the offspring of a patient who received medication;
    • conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.

    Measured: Up to 6 months.

  4. Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month

    Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.

    Measured: From the day of Percutaneous Coronary Intervention to 1 Month.

  5. Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months

    Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.

    Measured: From the day of Percutaneous Coronary Intervention to Month 6.

Secondary outcomes (3)

  1. Percentage of Participants With Binary Restenosis

    Binary restenosis was assessed by quantitative coronary angiography and defined as >50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory.

    Measured: 6 months

  2. Late Lumen Loss

    Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography.

    Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up.

    Measured: Day 0 (post-procedure baseline) and 6 months.

  3. Percentage of In-Stent Volume Obstruction at 6 Months

    In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume * 100.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00124943
Sponsor's protocol ID
CVR003
Acronym
SNAPIST-III
Status last verified
Mar 2012
First submitted
27 Jul 2005
Last updated
2 Apr 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nanoparticle Paclitaxel in people with Coronary Restenosis, run by Celgene Corporation.

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 12 inclusion and 29 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 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 8 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Phase I: Number of Participants With Dose-limiting Toxicities (time frame: Up to 1 week following percutaneous coronary intervention.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00124943.

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 2 Apr 2012.

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