Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Metastatic Breast Cancer Clinical Trial

Official title:

Phase II Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01019577
• Other study ID #: CA163-107
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2009
• Last updated: January 27, 2017
• Start date: October 2005
• Est. completion date: July 2007

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2007
• Est. primary completion date: July 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, Q3W, Maximum 9 cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria		Every cycle
Secondary	To evaluate the duration of achieved responses		For a maximum of 9 3-week cycles or until unacceptable toxicity
Secondary	To evaluate time to progression (TTP)		For a maximum of 9 3-week cycles or until 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