- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00124943
Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis (SNAPIST-III)
A Phase I/II Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
- 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.
- 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.
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 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 10 mg/m^2 nanoparticle paclitaxel
Participants 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).
|
Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
Other Names:
|
Experimental: 22 mg/m^2 nanoparticle paclitaxel
Participants 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).
|
Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
Other Names:
|
Experimental: 35 mg/m^2 nanoparticle paclitaxel
Participants 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).
|
Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
Other Names:
|
Experimental: 45 mg/m^2 nanoparticle paclitaxel
Participants 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).
|
Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase I: Number of Participants With Dose-limiting Toxicities
Time Frame: Up to 1 week following percutaneous coronary intervention.
|
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. |
Up to 1 week following percutaneous coronary intervention.
|
Number of Participants With Procedural Complications
Time Frame: From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).
|
Procedural complications include the following:
|
From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
Time Frame: Up to 6 months.
|
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:
|
Up to 6 months.
|
Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month
Time Frame: From the day of Percutaneous Coronary Intervention to 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.
|
From the day of Percutaneous Coronary Intervention to 1 Month.
|
Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months
Time Frame: From the day of Percutaneous Coronary Intervention to Month 6.
|
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.
|
From the day of Percutaneous Coronary Intervention to Month 6.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Binary Restenosis
Time Frame: 6 months
|
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.
|
6 months
|
Late Lumen Loss
Time Frame: Day 0 (post-procedure baseline) and 6 months.
|
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. |
Day 0 (post-procedure baseline) and 6 months.
|
Percentage of In-Stent Volume Obstruction at 6 Months
Time Frame: 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.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jose' Iglesias, MD, Celgene Corporation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Coronary Disease
- Coronary Stenosis
- Coronary Restenosis
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- CVR003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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