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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027208
• Other study ID #: CA163-130
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2009
• Last updated: January 27, 2017
• Start date: December 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2017
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m²

Locations

Country	Name	City	State
Japan	Local Institution	Bunkyo-Ku	Tokyo
Japan	Local Institution	Chuo-Ku	Tokyo
Japan	Local Institution	Fukuoka-Shi	Fukuoka
Japan	Local Institution	Iruma-Gun	Saitama
Japan	Local Institution	Isehara-Shi	Kanagawa
Japan	Local Institution	Kagoshima-Shi	Kagoshima
Japan	Local Institution	Kashiwa-Shi	Chiba
Japan	Local Institution	Matabashi-Shi	Gunma
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Niigata-Shi	Niigata
Japan	Local Institution	Saitama
Japan	Local Institution	Tokyo
Japan	Local Institution	Toshima-Ku	Tokyo
Japan	Local Institution	Utsunomiya	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	To evaluate the antitumor response according to the RECIST criteria		21-day cycles until documented disease progression or unacceptable toxicity
Secondary	To evaluate the duration of achieved responses		21-day cycles until documented disease progression or unacceptable toxicity
Secondary	To evaluate time to progression (TTP)		21-day cycles until documented disease progression or unacceptable toxicity

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form