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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01027208
First received: December 4, 2009
Last updated: February 3, 2010
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Ixabepilone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objectives will be assessed by combining data with the previous Phase II study CA163107 [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ] [ Designated as safety issue: No ]
  • To evaluate the antitumor response according to the RECIST criteria [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ] [ Designated as safety issue: No ]
  • To evaluate the duration of achieved responses [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ] [ Designated as safety issue: No ]
  • To evaluate time to progression (TTP) [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixabepilone Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m²
Other Name: Ixempra

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027208

Locations
Japan
Local Institution
Nagoya, Aichi, Japan, 464-8681
Local Institution
Kashiwa-Shi, Chiba, Japan, 277-0882
Local Institution
Fukuoka-Shi, Fukuoka, Japan
Local Institution
Matabashi-Shi, Gunma, Japan, 371-8511
Local Institution
Kagoshima-Shi, Kagoshima, Japan, 892-0833
Local Institution
Isehara-Shi, Kanagawa, Japan, 259-1193
Local Institution
Niigata-Shi, Niigata, Japan, 951-8566
Local Institution
Iruma-Gun, Saitama, Japan, 350-0495
Local Institution
Utsunomiya, Tochigi, Japan, 320-0834
Local Institution
Bunkyo-Ku, Tokyo, Japan, 113-8677
Local Institution
Chuo-Ku, Tokyo, Japan, 104-0045
Local Institution
Toshima-Ku, Tokyo, Japan, 170-8455
Local Institution
Saitama, Japan
Local Institution
Tokyo, Japan
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01027208     History of Changes
Other Study ID Numbers: CA163-130
Study First Received: December 4, 2009
Last Updated: February 3, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014