MedTrace Logo

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

NCT00593827 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2016-03-10

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • US Oncology Research

    collaborator INDUSTRY

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-08-31
Completion
2010-08-31

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 NCT00593827 on ClinicalTrials.gov