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Completed

NCT Number: NCT01027208

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

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ixabepilone

Drug

Lyophilized and solvent, IV, 10-50 mg/m²

Other names: Ixempra

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

R-Pharm

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 7, 2009
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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