Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Coronary Restenosis
Intervention:	Drug: Nanoparticle Paclitaxel

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
122 patients were randomized into the study and 112 received study medication.

Reporting Groups

	Description
10 mg/m^2 Nanoparticle Paclitaxel	Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
22 mg/m^2 Nanoparticle Paclitaxel	Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
35 mg/m^2 Nanoparticle Paclitaxel	Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
45 mg/m^2 Nanoparticle Paclitaxel	Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).

Participant Flow for 2 periods

Period 1: Phase I

	10 mg/m^2 Nanoparticle Paclitaxel	22 mg/m^2 Nanoparticle Paclitaxel	35 mg/m^2 Nanoparticle Paclitaxel	45 mg/m^2 Nanoparticle Paclitaxel
STARTED	3	3	3	3
COMPLETED	3	3	3	3
NOT COMPLETED	0	0	0	0

Period 2: Phase II

	10 mg/m^2 Nanoparticle Paclitaxel	22 mg/m^2 Nanoparticle Paclitaxel	35 mg/m^2 Nanoparticle Paclitaxel	45 mg/m^2 Nanoparticle Paclitaxel
STARTED	3 ^[1]	51 ^[1]	3 ^[1]	55 ^[1]
COMPLETED	3	49	3	50
NOT COMPLETED	0	2	0	5
Adverse Event	0	2	0	1
Protocol Violation	0	0	0	1
Lost to Follow-up	0	0	0	1
Withdrawal by Subject	0	0	0	2

[1]	Includes participants from Phase I who were followed for efficacy but not retreated in Phase II.

Baseline Characteristics

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Reporting Groups

	Description
10 mg/m^2 Nanoparticle Paclitaxel	Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
22 mg/m^2 Nanoparticle Paclitaxel	Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
35 mg/m^2 Nanoparticle Paclitaxel	Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
45 mg/m^2 Nanoparticle Paclitaxel	Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).

Baseline Measures

	10 mg/m^2 Nanoparticle Paclitaxel	22 mg/m^2 Nanoparticle Paclitaxel	35 mg/m^2 Nanoparticle Paclitaxel	45 mg/m^2 Nanoparticle Paclitaxel	Total
Number of Participants [units: participants]	3	51	3	55	112
Age [units: years] Mean ± Standard Deviation	63.7 ± 6.51	59.0 ± 9.26	63.3 ± 6.81	60.3 ± 8.89	59.9 ± 8.94
Gender [units: participants]
Female	1	20	1	15	37
Male	2	31	2	40	75
Race/Ethnicity, Customized [units: participants]
Black, of African Heritage	0	1	0	3	4
White, Non-Hispanic and Non-Latino	3	44	3	46	96
White, Hispanic or Latino	0	6	0	6	12
Weight [units: kg] Mean ± Standard Deviation	82.80 ± 10.318	83.56 ± 13.659	91.33 ± 21.333	85.01 ± 17.915	84.46 ± 15.880
Lesion type [units: participants]
Patients with de novo Lesions	3	49	3	50	105
Patients with In-Stent Restenosis Lesions	0	2	0	5	7
Diabetes mellitis [units: participants]
No Diabetes	3	40	2	46	91
Insulin Dependent	0	5	0	1	6
Non-Insulin Dependent	0	6	1	8	15
Minimum Lumen Diameter ^[1] [units: mm] Mean ± Standard Deviation	0.790 ± 0.3941	0.842 ± 0.3628	0.762 ± 0.1804	0.986 ± 0.3740	0.908 ± 0.3691
Reference Diameter ^[2] [units: mm] Mean ± Standard Deviation	2.668 ± 0.0753	2.577 ± 0.3899	2.650 ± 0.4290	2.703 ± 0.4664	2.643 ± 0.4259
Lesion Length ^[2] [units: mm] Mean ± Standard Deviation	6.342 ± 0.9086	10.720 ± 5.9338	7.900 ± 1.2630	10.067 ± 5.7097	10.203 ± 5.6932
Diameter Stenosis ^[3] [units: % diameter stenosis] Mean ± Standard Deviation	80.92 ± 9.521	68.94 ± 15.083	70.50 ± 8.789	66.28 ± 14.253	68.01 ± 14.523

[1]	Participant population = 3, 47, 3, 50 (103 total). Measures were obtained from the angiographic evaluation.
[2]	Participant population = 3, 50, 3, 54 (110 total). Measures were obtained from the angiographic evaluation.
[3]	Participant population = 3, 51, 3, 54 (111 total). Measures were obtained from the angiographic evaluation.

Outcome Measures

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1. Primary:

Phase I: Number of Participants With Dose-limiting Toxicities [ Time Frame: Up to 1 week following percutaneous coronary intervention. ]

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2. Primary:

Number of Participants With Procedural Complications [ Time Frame: From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure). ]

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3. Primary:

Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: Up to 6 months. ]

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4. Primary:

Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month [ Time Frame: From the day of Percutaneous Coronary Intervention to 1 Month. ]

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5. Primary:

Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months [ Time Frame: From the day of Percutaneous Coronary Intervention to Month 6. ]

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6. Secondary:

Percentage of Participants With Binary Restenosis [ Time Frame: 6 months ]

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7. Secondary:

Late Lumen Loss [ Time Frame: Day 0 (post-procedure baseline) and 6 months. ]

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8. Secondary:

Percentage of In-Stent Volume Obstruction at 6 Months [ Time Frame: 6 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Study data will not be published in part before the complete multicenter data has been reported in full, unless more than 1 year has elapsed since completion of the Study. Investigator/institution must supply copy of presentation or publication to Celgene within 30 days of publication. Celgene may request in writing within that 30 days that Celgene Confidential Information be deleted or be granted a 60 day delay prior to publication to permit intellectual property filings.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00124943 History of Changes
Other Study ID Numbers:	CVR003
Study First Received:	July 27, 2005
Results First Received:	February 21, 2012
Last Updated:	March 28, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Brazil: Ministry of Health Romania: National Medicines Agency