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

Celgene

Status and phase

Completed

Phase 2

Conditions

Coronary Artery Disease

Angina Pectoris

Treatments

Drug: Paclitaxel Nanoparticle Albumin Bound

Study type

Interventional

Funder types

Industry

Identifiers

NCT00093223

CVR001

Details and patient eligibility

About

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.

Full description

See inclusion/exclusion criteria.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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