A Safety Study of ABI-007 for In-Stent Restenosis

Study Overview
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Brief Summary
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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
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See inclusion/exclusion criteria.

Official Title
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A Phase II Safety Study of Systemic Nanoparticle Paclitaxel (ABI-007)for In-Stent Restenosis

Conditions
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Angina Pectoris, Coronary Artery Disease

Intervention / Treatment
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* Drug: Paclitaxel Nanoparticle Albumin Bound
* Drug: Paclitaxel Nanoparticle Albumin Bound
* Drug: Paclitaxel Nanoparticle Albumin Bound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria Related to Angioplasty: 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 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 Exclusion Criteria Related to ABI-007: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>35mg/m^2 infusion time is 3.5 minutes | Drug: Paclitaxel Nanoparticle Albumin Bound<br>* Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s).<br>Drug: Paclitaxel Nanoparticle Albumin Bound<br> <br> |
| Experimental: 2<br>2 doses of 35mg.m^2 with the second dose given 2 months later | Drug: Paclitaxel Nanoparticle Albumin Bound<br>* Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s).<br>Drug: Paclitaxel Nanoparticle Albumin Bound<br>* 35mg/35 infusion time is 3.5 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events and serious adverse events. |  | 6 months | 
| Major Adverse Cardiac Events at 2 months following the stent procedure. |  | 2 months | 
| Safety and tolerability for ABI-007 |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of restenosis at 6 months. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In-Stent Restenosis