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

November 11, 2015 updated by: Bayer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

65

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

  • Canada
      • Quebec, Canada, G1S 4L8
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Montreal, Quebec, Canada, H3T 1E2
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Tucson, Arizona, United States, 85724
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Bakersfield, California, United States, 93309
      • Palm Springs, California, United States, 92262
    • Colorado
      • Aurora, Colorado, United States, 80010
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Daytona Beach, Florida, United States, 32114
    • Illinois
      • Decatur, Illinois, United States, 62526
    • Indiana
      • New Albany, Indiana, United States, 47150
    • Maryland
      • Baltimore, Maryland, United States, 21204
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • New Jersey
      • Livingston, New Jersey, United States, 07039
    • New York
      • New York, New York, United States, 10021
      • Syracuse, New York, United States, 13210
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-3180
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78207
    • Washington
      • Tacoma, Washington, United States, 98405

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to treatment with ZK-Epo after 6 cycles
Time Frame: complete or partial response after 2 to 6 courses of therapy.
complete or partial response after 2 to 6 courses of therapy.

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 10, 2015

Last Update Submitted That Met QC Criteria

November 11, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91466
  • 307975 (Other Identifier: company internal)

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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