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Paclitaxel Nanoparticle Albumin Bound

Phase 2

Angina Pectoris | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Nov 18, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

Paclitaxel Nanoparticle Albumin Bound · 1 trial · 2 indications

Phase 2 1
NCT00093223A Safety Study of ABI-007 for In-Stent RestenosisAngina Pectoris
COMPLETED76 Analytics
PHASE2COMPLETED
A Safety Study of ABI-007 for In-Stent Restenosis
Angina Pectoris
NCT0009322376
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events and serious adverse events.
6 months
Major Adverse Cardiac Events at 2 months following the stent procedure.
2 months
Safety and tolerability for ABI-007
2 Years

Secondary Endpoints

Evaluation of restenosis at 6 months.
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL35mg/m\^2 infusion time is 3.5 minutes
2EXPERIMENTAL2 doses of 35mg.m\^2 with the second dose given 2 months later

Interventions

NameTypeDescription
Paclitaxel Nanoparticle Albumin BoundDRUGSingle or duel doses of 35mg/m\^2 ABI-007, administered IV, administered after placement of denovo stent(s).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 trea...

Countries:United States
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