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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00313248
Collaborator
(none)
65
Enrollment
25
Locations
2
Arms
31
Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Sagopilone (ZK 219477)
  • 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, Inc.is the sponsor of this study.

Study Design

Study Type:
Interventional
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 :
Apr 1, 2006
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

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

    		•
    Experimental: Arm 2

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response to treatment with ZK-Epo after 6 cycles [complete or partial response after 2 to 6 courses of therapy.]

    Secondary Outcome Measures

    1. Safety and tolerability of ZK-Epo [time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35233
    2 Anchorage Alaska United States 99508
    3 Tucson Arizona United States 85724
    4 Hot Springs Arkansas United States 71913
    5 Bakersfield California United States 93309
    6 Palm Springs California United States 92262
    7 Aurora Colorado United States 80010
    8 Washington District of Columbia United States 20007
    9 Daytona Beach Florida United States 32114
    10 Decatur Illinois United States 62526
    11 New Albany Indiana United States 47150
    12 Baltimore Maryland United States 21204
    13 Minneapolis Minnesota United States 55455
    14 Livingston New Jersey United States 07039
    15 New York New York United States 10021
    16 Syracuse New York United States 13210
    17 Portland Oregon United States 97239
    18 Pittsburgh Pennsylvania United States 15213-3180
    19 Houston Texas United States 77030
    20 San Antonio Texas United States 78207
    21 Tacoma Washington United States 98405
    22 Toronto Ontario Canada M4N 3M5
    23 Greenfield Park Quebec Canada J4V 2H1
    24 Montreal Quebec Canada H3T 1E2
    25 Quebec Canada G1S 4L8

    Sponsors and Collaborators

    • Bayer

    Investigators

    • Study Director: Bayer Study Director, Bayer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bayer
    ClinicalTrials.gov Identifier:
    NCT00313248
    Other Study ID Numbers:
    • 91466
    • 307975
    First Posted:
    Apr 12, 2006
    Last Update Posted:
    Dec 10, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Bayer
    Breast Cancer
    Metastatic Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Sagopilone
    Epothilones

    Study Results

    No Results Posted as of Dec 10, 2015