Trial Outcomes & Findings for Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis (NCT NCT00124943)
NCT ID: NCT00124943
Last Updated: 2012-04-02
Results Overview
Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting. The maximum tolerated dose was defined as the lesser of 45 mg/m\^2 or the dose at which any drug related toxicities were observed.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
112 participants
Primary outcome timeframe
Up to 1 week following percutaneous coronary intervention.
Results posted on
2012-04-02
Participant Flow
122 patients were randomized into the study and 112 received study medication.
Participant milestones
| Measure |
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).
|
|---|---|---|---|---|
|
Phase II
NOT COMPLETED
|
0
|
2
|
0
|
5
|
|
Phase I
STARTED
|
3
|
3
|
3
|
3
|
|
Phase I
COMPLETED
|
3
|
3
|
3
|
3
|
|
Phase I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
3
|
51
|
3
|
55
|
|
Phase II
COMPLETED
|
3
|
49
|
3
|
50
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|---|---|
|
Phase II
Adverse Event
|
0
|
2
|
0
|
1
|
|
Phase II
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Phase II
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Phase II
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis
Baseline characteristics by cohort
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=51 Participants
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
n=3 Participants
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
n=55 Participants
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).
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
63.7 years
STANDARD_DEVIATION 6.51 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 9.26 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 6.81 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 8.89 • n=4 Participants
|
59.9 years
STANDARD_DEVIATION 8.94 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic and Non-Latino
|
3 participants
n=5 Participants
|
44 participants
n=7 Participants
|
3 participants
n=5 Participants
|
46 participants
n=4 Participants
|
96 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic or Latino
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
0 participants
n=5 Participants
|
6 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Weight
|
82.80 kg
STANDARD_DEVIATION 10.318 • n=5 Participants
|
83.56 kg
STANDARD_DEVIATION 13.659 • n=7 Participants
|
91.33 kg
STANDARD_DEVIATION 21.333 • n=5 Participants
|
85.01 kg
STANDARD_DEVIATION 17.915 • n=4 Participants
|
84.46 kg
STANDARD_DEVIATION 15.880 • n=21 Participants
|
|
Lesion type
Patients with de novo Lesions
|
3 participants
n=5 Participants
|
49 participants
n=7 Participants
|
3 participants
n=5 Participants
|
50 participants
n=4 Participants
|
105 participants
n=21 Participants
|
|
Lesion type
Patients with In-Stent Restenosis Lesions
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Diabetes mellitis
No Diabetes
|
3 participants
n=5 Participants
|
40 participants
n=7 Participants
|
2 participants
n=5 Participants
|
46 participants
n=4 Participants
|
91 participants
n=21 Participants
|
|
Diabetes mellitis
Insulin Dependent
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Diabetes mellitis
Non-Insulin Dependent
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
1 participants
n=5 Participants
|
8 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Minimum Lumen Diameter
|
0.790 mm
STANDARD_DEVIATION 0.3941 • n=5 Participants
|
0.842 mm
STANDARD_DEVIATION 0.3628 • n=7 Participants
|
0.762 mm
STANDARD_DEVIATION 0.1804 • n=5 Participants
|
0.986 mm
STANDARD_DEVIATION 0.3740 • n=4 Participants
|
0.908 mm
STANDARD_DEVIATION 0.3691 • n=21 Participants
|
|
Reference Diameter
|
2.668 mm
STANDARD_DEVIATION 0.0753 • n=5 Participants
|
2.577 mm
STANDARD_DEVIATION 0.3899 • n=7 Participants
|
2.650 mm
STANDARD_DEVIATION 0.4290 • n=5 Participants
|
2.703 mm
STANDARD_DEVIATION 0.4664 • n=4 Participants
|
2.643 mm
STANDARD_DEVIATION 0.4259 • n=21 Participants
|
|
Lesion Length
|
6.342 mm
STANDARD_DEVIATION 0.9086 • n=5 Participants
|
10.720 mm
STANDARD_DEVIATION 5.9338 • n=7 Participants
|
7.900 mm
STANDARD_DEVIATION 1.2630 • n=5 Participants
|
10.067 mm
STANDARD_DEVIATION 5.7097 • n=4 Participants
|
10.203 mm
STANDARD_DEVIATION 5.6932 • n=21 Participants
|
|
Diameter Stenosis
|
80.92 % diameter stenosis
STANDARD_DEVIATION 9.521 • n=5 Participants
|
68.94 % diameter stenosis
STANDARD_DEVIATION 15.083 • n=7 Participants
|
70.50 % diameter stenosis
STANDARD_DEVIATION 8.789 • n=5 Participants
|
66.28 % diameter stenosis
STANDARD_DEVIATION 14.253 • n=4 Participants
|
68.01 % diameter stenosis
STANDARD_DEVIATION 14.523 • n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 1 week following percutaneous coronary intervention.Population: Phase I treated population.
Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events version 3.0. Any drug-related toxicities considered CTC Grade 3 or 4 were considered dose limiting. The maximum tolerated dose was defined as the lesser of 45 mg/m\^2 or the dose at which any drug related toxicities were observed.
Outcome measures
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=3 Participants
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
n=3 Participants
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
n=3 Participants
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).
|
|---|---|---|---|---|
|
Phase I: Number of Participants With Dose-limiting Toxicities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From Day 0 - Day 1 (from study drug administration until 24 hours post-procedure).Population: Treated population.
Procedural complications include the following: 1. Haemodynamic monitoring: changes in heart rate, arterial blood pressure or electrocardiogram changes; 2. Arrhythmia: premature ventricular complexes, brady or tachyarrhythmia; 3. Allergic reactions: rash, flushing, pyrexia, urticaria, angio-oedema; 4. Angiographic complications: coronary artery spasm, dissection, thrombosis, TIMI (Thrombolysis In Myocardial Infarction) flow, no reflow; 5. Clinical changes: chest pain.
Outcome measures
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=51 Participants
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
n=3 Participants
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
n=55 Participants
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).
|
|---|---|---|---|---|
|
Number of Participants With Procedural Complications
|
1 participants
|
5 participants
|
1 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Up to 6 months.Population: Treated population.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. An SAE is any event that: * is fatal or life threatening * results in persistent or significant disability or or incapacity; * requires or prolongs existing hospitalization; * is a congenital anomaly/birth defect in the offspring of a patient who received medication; * conditions not included above that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=51 Participants
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
n=3 Participants
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
n=55 Participants
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).
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
Patients with at Least 1 Serious AE
|
0 participants
|
14 participants
|
0 participants
|
18 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs)
Patients with at Least 1 AE
|
3 participants
|
43 participants
|
3 participants
|
48 participants
|
PRIMARY outcome
Timeframe: From the day of Percutaneous Coronary Intervention to 1 Month.Population: Treated population.
Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.
Outcome measures
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=51 Participants
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
n=3 Participants
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
n=55 Participants
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).
|
|---|---|---|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE) at 1 Month
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: From the day of Percutaneous Coronary Intervention to Month 6.Population: Treated population.
Major Adverse Cardiac Events (MACE) includes cardiac death, Coronary Artery Bypass Surgery, Myocardial Infarction, Target Vessel Revascularization (TVR) or Target Lesion Revascularization (TLR) and stent/vessel thrombotic occlusion.
Outcome measures
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=51 Participants
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
n=3 Participants
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
n=54 Participants
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).
|
|---|---|---|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE) at 6 Months
|
0 participants
|
7 participants
|
0 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Treated Population.
Binary restenosis was assessed by quantitative coronary angiography and defined as \>50% diameter stenosis within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) at follow-up. Angiograms were centrally assessed by the Angiographic Core Laboratory.
Outcome measures
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=51 Participants
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
n=3 Participants
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
n=55 Participants
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).
|
|---|---|---|---|---|
|
Percentage of Participants With Binary Restenosis
In-stent
|
0.0 percentage of participants
|
25.5 percentage of participants
|
0.0 percentage of participants
|
34.5 percentage of participants
|
|
Percentage of Participants With Binary Restenosis
In-segment
|
0.0 percentage of participants
|
27.5 percentage of participants
|
0.0 percentage of participants
|
34.5 percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (post-procedure baseline) and 6 months.Population: Treated population for whom data was available (indicated by "n").
Late lumen loss represents the extent of neointimal hyperplasia within the stented region (In-stent) or the stented region plus 5 mm on either side of the stent (In-segment) and was measured by quantitative coronary angiography. Late Loss = Minimum Lumen Diameter (MLD) Post Procedure minus the MLD at Follow-up.
Outcome measures
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=51 Participants
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
n=3 Participants
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
n=55 Participants
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).
|
|---|---|---|---|---|
|
Late Lumen Loss
In-stent [n=3, 46, 3, 50]
|
0.403 mm
Standard Deviation 0.2267
|
0.871 mm
Standard Deviation 0.4188
|
0.747 mm
Standard Deviation 0.1626
|
0.835 mm
Standard Deviation 0.5328
|
|
Late Lumen Loss
In-segment [n=3, 47, 3, 50]
|
0.281 mm
Standard Deviation 0.2116
|
0.631 mm
Standard Deviation 0.4070
|
0.355 mm
Standard Deviation 0.3101
|
0.697 mm
Standard Deviation 0.5323
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Treated population for whom data was available.
In-stent volume obstruction at 6 months was measured by intra-vascular ultrasound (IVUS) and centrally assessed by the IVUS Core Laboratory. Percent in-stent volume obstruction was calculated as neointimal volume / stent volume \* 100.
Outcome measures
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 Participants
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
n=40 Participants
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
n=3 Participants
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
n=43 Participants
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).
|
|---|---|---|---|---|
|
Percentage of In-Stent Volume Obstruction at 6 Months
|
14.080 Percentage of obstruction
Standard Deviation 11.5163
|
24.908 Percentage of obstruction
Standard Deviation 15.3220
|
31.016 Percentage of obstruction
Standard Deviation 8.9722
|
21.663 Percentage of obstruction
Standard Deviation 14.0249
|
Adverse Events
10 mg/m^2 Nanoparticle Paclitaxel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
22 mg/m^2 Nanoparticle Paclitaxel
Serious events: 14 serious events
Other events: 34 other events
Deaths: 0 deaths
35 mg/m^2 Nanoparticle Paclitaxel
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
45 mg/m^2 Nanoparticle Paclitaxel
Serious events: 18 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 participants at risk
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
n=51 participants at risk
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
n=3 participants at risk
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
n=55 participants at risk
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).
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.00%
0/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
14.5%
8/55 • Up to 6 months.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/3 • Up to 6 months.
|
5.9%
3/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
12.7%
7/55 • Up to 6 months.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Vascular disorders
Arterial restenosis
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
Other adverse events
| Measure |
10 mg/m^2 Nanoparticle Paclitaxel
n=3 participants at risk
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
n=51 participants at risk
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
n=3 participants at risk
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
n=55 participants at risk
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).
|
|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
33.3%
1/3 • Up to 6 months.
|
5.5%
3/55 • Up to 6 months.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
66.7%
2/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
5.5%
3/55 • Up to 6 months.
|
|
Investigations
Troponin T increased
|
66.7%
2/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
33.3%
1/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Investigations
Electrocardiogram ST-T change
|
33.3%
1/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
33.3%
1/3 • Up to 6 months.
|
3.6%
2/55 • Up to 6 months.
|
|
Investigations
Troponin increased
|
0.00%
0/3 • Up to 6 months.
|
3.9%
2/51 • Up to 6 months.
|
33.3%
1/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
General disorders
Chest discomfort
|
33.3%
1/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
General disorders
Chest pain
|
33.3%
1/3 • Up to 6 months.
|
9.8%
5/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
7.3%
4/55 • Up to 6 months.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to 6 months.
|
3.9%
2/51 • Up to 6 months.
|
33.3%
1/3 • Up to 6 months.
|
5.5%
3/55 • Up to 6 months.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
3.6%
2/55 • Up to 6 months.
|
|
Nervous system disorders
Paraesthesia
|
33.3%
1/3 • Up to 6 months.
|
3.9%
2/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
3.6%
2/55 • Up to 6 months.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 6 months.
|
5.9%
3/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
33.3%
1/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Up to 6 months.
|
5.9%
3/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
3.6%
2/55 • Up to 6 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 6 months.
|
3.9%
2/51 • Up to 6 months.
|
33.3%
1/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
3.6%
2/55 • Up to 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 6 months.
|
5.9%
3/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Vascular disorders
Haematoma
|
33.3%
1/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
33.3%
1/3 • Up to 6 months.
|
5.5%
3/55 • Up to 6 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
9.1%
5/55 • Up to 6 months.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
9.1%
5/55 • Up to 6 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to 6 months.
|
5.9%
3/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 6 months.
|
7.8%
4/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 6 months.
|
3.9%
2/51 • Up to 6 months.
|
33.3%
1/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/51 • Up to 6 months.
|
33.3%
1/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 6 months.
|
5.9%
3/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
0.00%
0/55 • Up to 6 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 6 months.
|
9.8%
5/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 6 months.
|
2.0%
1/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
5.5%
3/55 • Up to 6 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 6 months.
|
5.9%
3/51 • Up to 6 months.
|
0.00%
0/3 • Up to 6 months.
|
1.8%
1/55 • Up to 6 months.
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee * 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.
- Publication restrictions are in place
Restriction type: OTHER