NCT00093223

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

A Phase II Safety Study of Systemic Nanoparticle Paclitaxel (ABI-007)for In-Stent Restenosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

See inclusion/exclusion criteria.

Conditions

• Angina Pectoris
• Coronary Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-09-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2004-10-07
• Last updated: 2019-11-18

Locations

1 site across 1 country: United States