A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01027208
First received: December 4, 2009
Last updated: February 3, 2010
Last verified: January 2010
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Ixabepilone
U.S. FDA Resources
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
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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Epothilones Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013