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Sponsored by: |
Abraxis BioScience Inc. |
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Information provided by: | Abraxis BioScience Inc. |
ClinicalTrials.gov Identifier: | NCT00124943 |
The purpose of this study is to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.
Condition | Intervention | Phase |
---|---|---|
Coronary Restenosis |
Drug: ABI-007 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Safety Trial of Intracoronary Administration of Systemic Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis |
Estimated Enrollment: | 112 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ABI-007
10mg/m^2 ABI-007
|
2: Experimental |
Drug: ABI-007
22mg/m^2 ABI-007
|
3: Experimental |
Drug: ABI-007
35mg^2 ABI-007
|
4: Experimental |
Drug: ABI-007
45mg/m^2 ABI-007
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The following lab values at baseline are exclusionary:
Responsible Party: | Abraxis BioScience ( Robert M. Hernandez, PhD/ Clinical Trials Manager ) |
Study ID Numbers: | CVR003 |
Study First Received: | July 27, 2005 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00124943 |
Health Authority: | United States: Food and Drug Administration |
Prevention of Instent Restenosis |
Coronary Disease Heart Diseases Paclitaxel Myocardial Ischemia Vascular Diseases |
Constriction, Pathologic Ischemia Coronary Stenosis Coronary Restenosis Coronary Artery Disease |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Mitosis Modulators Tubulin Modulators |
Cardiovascular Diseases Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |