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Completed

NCT Number: NCT01019577

Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

The purpose of this study is to determine the response rates for Ixabepilone (BMS-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.

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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

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, Q3W, Maximum 9 cycles

Other names: Ixempra, BMS-247550

Primary outcomes

  1. To assess the tumor response using RECIST Criteria to determine the best overall response and response rate

    Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

Secondary outcomes

  1. To evaluate safety of BMS-247550 (AEs, SAEs, Deaths, treatment related AEs) using CTC Criteria

    Time frame: Every cycle

  2. To evaluate the duration of achieved responses

    Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

  3. To evaluate time to progression (TTP)

    Time frame: For a maximum of 9 3-week cycles or until unacceptable toxicity

Sponsors and collaborators

Lead sponsor

R-Pharm

Industry

Registry information

Official study title

Phase II Clinical Study of Ixabepilone (BMS-247550) by Every-3-week Dosing Regimen in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and Who Are Taxane Resistant

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 25, 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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