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Completed

NCT Number: NCT00313248

Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Toronto, Ontario, Canada

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About this study

This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Metastatic breast cancer (meaning the cancer has spread beyond its original location)
  • At least one measurable lesion by CT or MRI
  • Progression of disease following previous therapy for breast cancer
  • Have received previous treatment with anthracyclines (e.g. doxorubicin[Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [taxotere]) for your breast cancer
  • Not be pregnant
  • Additional criteria to be determined at screening visit.

Exclusion criteria

  • More than 3 previous chemotherapy regimens
  • More than one treatment with non cytotoxic agents for breast cancer therapy (e.g. herceptin [trastuzumab] or Avastin [bevacizumab)
  • Prior treatment with epothilones (e.g. Ixabepilone)
  • Symptomatic brain metastases
  • Additional criteria to be determined at screening visit

Treatment and study plan

Sagopilone (ZK 219477)

Drug

All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.

Other names: BAY86-5302

Primary outcomes

  1. Response to treatment with ZK-Epo after 6 cycles

    Time frame: complete or partial response after 2 to 6 courses of therapy.

Secondary outcomes

  1. Safety and tolerability of ZK-Epo

    Time frame: time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 12, 2006
Registry last updated
Dec 10, 2015

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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