NCT01019577

Brief Summary

The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

November 24, 2009

Last Update Submit

January 27, 2017

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • To assess the tumor response using RECIST Criteria to determine the best overall response and response rate

    For a maximum of 9 3-week cycles or until unacceptable toxicity

Secondary Outcomes (3)

  • To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria

    Every cycle

  • To evaluate the duration of achieved responses

    For a maximum of 9 3-week cycles or until unacceptable toxicity

  • To evaluate time to progression (TTP)

    For a maximum of 9 3-week cycles or until unacceptable toxicity

Study Arms (1)

Ixabepilone

EXPERIMENTAL
Drug: Ixabepilone

Interventions

IxabepiloneDRUG

Lyophilized and solvent, IV, 10-50 mg/m2, Q3W, Maximum 9 cycles

Also known as: Ixempra, BMS-247550
Ixabepilone

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 20 years or older
  • Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination

You may not qualify if:

  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥ 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

October 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 30, 2017

Record last verified: 2017-01