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Nanoparticle Paclitaxel

Phase 1

Coronary Restenosis | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Apr 2, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment112
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00124943Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent RestenosisPHASE1 COMPLETED 112Jul 1, 2005Aug 1, 2009Apr 2, 2012 -
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Study Endpoints
Primary Endpoints
Phase I: Number of Participants With Dose-limiting Toxicities
Up to 1 week following percutaneous coronary intervention.

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.

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

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.

Number of Participants With Treatment Emergent Adverse Events (AEs)
Up to 6 months.

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.

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

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.

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

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.

Secondary Endpoints
Percentage of Participants With Binary Restenosis
6 months
Late Lumen Loss
Day 0 (post-procedure baseline) and 6 months.
Percentage of In-Stent Volume Obstruction at 6 Months
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
10 mg/m^2 nanoparticle paclitaxelEXPERIMENTALParticipants 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 paclitaxelEXPERIMENTALParticipants 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 paclitaxelEXPERIMENTALParticipants 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 paclitaxelEXPERIMENTALParticipants 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).
Interventions
NameTypeDescription
Nanoparticle PaclitaxelDRUGNanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male or non-pregnant and non-lactating female, and ≥ 18 years of age. * Diagnosis of angina pectoris or unstable angina pectoris or patients with documented silent ischemia. * Left ventricular ejection fraction ≥30% * Patient has undergone successful and uncomplicated stenting...

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