A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline

A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline And Who Are Taxane Resistant Who Have Completed Study CA163107 And Who Are Benefiting From Continuation On Therapy With Ixabepilone

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01027208

Enrollment

Registered

2009-12-07

Start date

2006-12-31

Completion date

2007-01-31

Last updated

2017-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Brief summary

To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)

Interventions

DRUGIxabepilone

Lyophilized and solvent, IV, 10-50 mg/m²

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator	21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the frequency and the severity of observed adverse reactions in treated patients, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	21-day cycles until documented disease progression or unacceptable toxicity

Secondary

Measure	Time frame
Secondary objectives will be assessed by combining data with the previous Phase II study CA163107	21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the antitumor response according to the RECIST criteria	21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the duration of achieved responses	21-day cycles until documented disease progression or unacceptable toxicity
To evaluate time to progression (TTP)	21-day cycles until documented disease progression or unacceptable toxicity

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026