A Safety Study of ABI-007 for In-Stent Restenosis - Full Text View

Sponsored by:	Abraxis BioScience Inc.
Information provided by:	Abraxis BioScience Inc.
ClinicalTrials.gov Identifier:	NCT00093223

Purpose

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.

Condition	Intervention	Phase
Angina Pectoris Coronary Artery Disease	Drug: Paclitaxel Nanoparticle Albumin Bound	Phase II

MedlinePlus related topics: Angina Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Further study details as provided by Abraxis BioScience Inc.:

Primary Outcome Measures:

Incidence of treatment-emergent adverse events and serious adverse events. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Major Adverse Cardiac Events at 2 months following the stent procedure. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Safety and tolerability for ABI-007 [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluation of restenosis at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	99
Study Start Date:	September 2001
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 35mg/m^2 infusion time is 3.5 minutes	Drug: Paclitaxel Nanoparticle Albumin Bound Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s). Drug: Paclitaxel Nanoparticle Albumin Bound
2: Experimental 2 doses of 35mg.m^2 with the second dose given 2 months later	Drug: Paclitaxel Nanoparticle Albumin Bound Single or duel doses of 35mg/m^2 ABI-007, administered IV, administered after placement of denovo stent(s). Drug: Paclitaxel Nanoparticle Albumin Bound 35mg/35 infusion time is 3.5 minutes

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093223

Locations

United States, North Carolina
Abraxis BioScience, Inc.
Durham, North Carolina, United States, 27703

Sponsors and Collaborators

Abraxis BioScience Inc.

Investigators

Study Director:

Angela Ogden, MD

Abraxis BioScience Inc.

More Information

Responsible Party:	Abraxis BioScience ( Selena Rush, Senior Clinical Trials Manager )
Study ID Numbers:	CVR001-0
Study First Received:	October 4, 2004
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00093223
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:

In-Stent Restenosis

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Ischemia

Arteriosclerosis
Chest Pain
Coronary Disease
Signs and Symptoms
Paclitaxel
Coronary Artery Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators

Cardiovascular Diseases
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009