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

January 27, 2017 updated by: R-Pharm

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Saitama, Japan
        • Local Institution
      • Tokyo, Japan
        • Local Institution
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Local Institution
    • Chiba
      • Kashiwa-Shi, Chiba, Japan, 277-0882
        • Local Institution
    • Fukuoka
      • Fukuoka-Shi, Fukuoka, Japan
        • Local Institution
    • Gunma
      • Matabashi-Shi, Gunma, Japan, 371-8511
        • Local Institution
    • Kagoshima
      • Kagoshima-Shi, Kagoshima, Japan, 892-0833
        • Local Institution
    • Kanagawa
      • Isehara-Shi, Kanagawa, Japan, 259-1193
        • Local Institution
    • Niigata
      • Niigata-Shi, Niigata, Japan, 951-8566
        • Local Institution
    • Saitama
      • Iruma-Gun, Saitama, Japan, 350-0495
        • Local Institution
    • Tochigi
      • Utsunomiya, Tochigi, Japan, 320-0834
        • Local Institution
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-8677
        • Local Institution
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • Local Institution
      • Toshima-Ku, Tokyo, Japan, 170-8455
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ixabepilone
Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m²
Other Names:
  • Ixempra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
21-day cycles until documented disease progression or unacceptable toxicity
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
21-day cycles until documented disease progression or unacceptable toxicity

Secondary Outcome Measures

Outcome Measure
Time Frame
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
21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the antitumor response according to the RECIST criteria
Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity
21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the duration of achieved responses
Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity
21-day cycles until documented disease progression or unacceptable toxicity
To evaluate time to progression (TTP)
Time Frame: 21-day cycles until documented disease progression or unacceptable toxicity
21-day cycles until documented disease progression or unacceptable toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Pharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (Estimate)

December 7, 2009

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA163-130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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