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

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ClinicalTrials.gov Identifier: NCT01027208
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : January 30, 2017
Sponsor:
Information provided by:
R-Pharm

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Ixabepilone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ixabepilone

Arm Intervention/treatment
Experimental: Ixabepilone Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m²
Other Name: Ixempra




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the antitumor response according to the RECIST criteria [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ]
  3. To evaluate the duration of achieved responses [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ]
  4. To evaluate time to progression (TTP) [ Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
R-Pharm
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01027208     History of Changes
Other Study ID Numbers: CA163-130
First Posted: December 7, 2009    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

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
Antineoplastic Agents