Expired Study
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La Verne, California


Purpose:

The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.


Criteria:

Inclusion Criteria: - Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant - No more than 3 prior chemotherapy regimens in the metastatic setting - Must have at least one target lesion that is radiographically measurable - Good performance status - No history of or current brain or leptomeningeal disease


Study is Available At:


Original ID:

CA163-081


NCT ID:

NCT00080262


Secondary ID:


Study Acronym:


Brief Title:

Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)


Official Title:

Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

R-Pharm


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

125


Enrollment Type:


Overall Contact Information

Official Name:Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Study Dates

Start Date:February 2004
Completion Date:December 2006
Completion Type:Actual
Primary Completion Date:December 2006
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 27, 2017
First Received Date:March 25, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Time to progression, duration of response, overall survival
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Response rate as determined by the IRRC
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ixabepilone
Description:Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.
Arm Name:1
Other Name:BMS-247550

Study Arms

Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:R-Pharm

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Perez EA, Lerzo G, Pivot X, Thomas E, Vahdat L, Bosserman L, Viens P, Cai C, Mullaney B, Peck R, Hortobagyi GN. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007 Aug 10;25(23):3407-14.
PMID:17606974

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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