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A Safety Study of ABI-007 for In-Stent Restenosis

NCT00093223 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-11-18

No results posted yet for this study

Summary

This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries. The purpose of the trial is to determine the appropriate dose of the new medicine for future trials and to evaluate the incidence of treatment-emergent adverse events and serious adverse events.

Conditions

Interventions

DRUG

Paclitaxel Nanoparticle Albumin Bound

Single or duel doses of 35mg/m\^2 ABI-007, administered IV, administered after placement of denovo stent(s).

DRUG

Paclitaxel Nanoparticle Albumin Bound

DRUG

Paclitaxel Nanoparticle Albumin Bound

35mg/35 infusion time is 3.5 minutes

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • José Iglesias, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-01
Primary Completion
2007-12-01
Completion
2007-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00093223 on ClinicalTrials.gov