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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00313248
Recruitment Status : Completed
First Posted : April 12, 2006
Last Update Posted : December 10, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: Sagopilone (ZK 219477) Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
Study Start Date : April 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm 1 Drug: Sagopilone (ZK 219477)
All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
Other Name: BAY86-5302

Experimental: Arm 2 Drug: Sagopilone (ZK 219477)
Patients will receive 22mg/m2 as intravenous infusion.
Other Name: BAY86-5302

Primary Outcome Measures :
  1. Response to treatment with ZK-Epo after 6 cycles [ Time Frame: complete or partial response after 2 to 6 courses of therapy. ]

Secondary Outcome Measures :
  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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00313248

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT00313248     History of Changes
Other Study ID Numbers: 91466
307975 ( Other Identifier: company internal )
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: November 2015

Keywords provided by Bayer:
Breast Cancer
Metastatic Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action