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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Ixabepilone

• Registration Number: NCT01027208
• Lead Sponsor: R-Pharm

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ixabepilone	Ixabepilone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 time to progression (TTP)	21-day cycles until documented disease progression or unacceptable toxicity

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Tokyo, Japan