NCT00593827

Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer

Phase II Randomized Trial of Weekly and Every 3-week Ixabepilone in Metastatic Breast Cancer (MBC) Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: R-Pharm · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Ixabepilone	Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
DRUG	Ixabepilone	Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-01-15
• Last updated: 2016-03-10
• Results posted: 2012-05-25

Locations

57 sites across 1 country: United States