A Safety Study of ABI-007 for In-Stent Restenosis
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00093223
First received: October 4, 2004
Last updated: March 27, 2013
Last verified: October 2011
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Safety Study of Systemic Nanoparticle Paclitaxel (ABI-007)for In-Stent Restenosis |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
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: | 76 |
| Study Start Date: | September 2001 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
|
Experimental: 2
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
|
Detailed Description:
See inclusion/exclusion criteria.
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
Celgene Corporation
Investigators
| Study Director: | José Iglesias, MD | Celgene Corporation |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00093223 History of Changes |
| Other Study ID Numbers: | CVR001 |
| Study First Received: | October 4, 2004 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Celgene Corporation:
|
In-Stent Restenosis |
Additional relevant MeSH terms:
|
Angina Pectoris Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Arteriosclerosis |
Arterial Occlusive 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 May 16, 2013