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Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis
This study has been completed.

First Received on July 27, 2005.   Last Updated on October 6, 2011   History of Changes
Sponsor: Celgene Corporation
Information provided by (Responsible Party): Celgene Corporation
ClinicalTrials.gov Identifier: NCT00124943
  Purpose

The purpose of this study is 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.


Condition Intervention Phase
Coronary Restenosis
Drug: ABI-007
Phase I
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Incidence of any procedural complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • to determine a safe and appropriate intracoronary dose for future clinical trials of ABI-007 administered to patients after successful PTCA and stenting of de novo lesions or angioplasty of ISR lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • to evaluate the incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Restenosis at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 112
Study Start Date: July 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ABI-007
10mg/m^2 ABI-007
Experimental: 2 Drug: ABI-007
22mg/m^2 ABI-007
Experimental: 3 Drug: ABI-007
35mg^2 ABI-007
Experimental: 4 Drug: ABI-007
45mg/m^2 ABI-007

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • TIMI 3 coronary flow post-stenting for de novo lesions or post balloon angioplasty for ISR lesions.
  • No angiographic evidence of thrombus post-procedure.
  • Target vessel ≥2.5mm diameter (by angiography).
  • Each de novo lesion is such that it is stented with ≤ 25mm of single continuous stent.
  • Each in-stent restenosis (ISR) lesion is ≤ 25mm in length.
  • There is at least 5mm 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 2.5mm or an in-stent luminal area ≥5.0mm2
  • 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.

Exclusion Criteria:

  • 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 PCI, or it is anticipated that additional lesions will require treatment within 2 months.
  • Previous percutaneous coronary intervention (PCI) within preceding two months.
  • Intended surgical intervention within 6 months of enrollment in the study.
  • 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 CK≥2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of the procedure.
  • Cardiogenic shock: sustained systolic blood pressure (SBP) less than 80mmHg, with no response to fluids or SBP less than 100mmHg 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/mm3;
    • Absolute neutrophil count (ANC) < 2000 cells/mm3;
    • Hemoglobin (HGB) <9g/dl;
    • Total bilirubin >1.5mg/dl;
    • ALT (SGPT) > 2.5 x upper limit of normal range (ULN);
    • AST (SGOT) > 2.5 x upper limit of normal range (ULN);
    • Alkaline phosphatase > 2.5 x upper limit of normal (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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124943

Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Jose' Iglesias, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00124943     History of Changes
Other Study ID Numbers: CVR003
Study First Received: July 27, 2005
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Prevention of Instent Restenosis

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012