check_circleStudy Completed

Breast Neoplasm

Bayer Identifier:

91466

ClinicalTrials.gov Identifier:

NCT00313248

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 Years
  • - 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.
  • - 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

Trial summary

Enrollment Goal
65
Trial Dates
April 2006 - November 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
M. D. Anderson Cancer Center - University of TexasHouston, 77030, United States
Completed
Cancer Care Center, Inc.New Albany, 47150, United States
Completed
University of Alabama at BirminghamBirmingham, 35233, United States
Completed
Georgetown University Medical CenterWashington, 20007, United States
Completed
Genesis Cancer CenterHot Springs, 71913, United States
Completed
Hopital du St-SacrementQuebec, G1S 4L8, Canada
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada
Completed
Greater Baltimore Medical CenterBaltimore, 21204, United States
Terminated
Halifax Health Medical CenterDaytona Beach, 32114, United States
Completed
Tacoma General HospitalTacoma, 98405, United States
Completed
Comprehensive Blood and Cancer CenterBakersfield, 93309, United States
Completed
Comprehensive Cancer CenterPalm Springs, 92262, United States
Completed
Weill Cornell Breast CenterNew York, 10021, United States
Completed
South Texas Oncology & Hematology, P.A.San Antonio, 78207, United States
Completed
Alaska Cancer Research and Education CenterAnchorage, 99508, United States
Completed
Saint Barnabas Medical CenterLivingston, 07039, United States
Completed
Oregon Health and Science UniversityPortland, 97239, United States
Terminated
SUNY Upstate Medical UniversitySyracuse, 13210, United States
Completed
University of Colorado HospitalAurora, 80010, United States
Completed
Magee Womens Hospital of UPMCPittsburgh, 15213-3180, United States
Completed
Sunnybrook Health Sciences CentreToronto, M4N 3M5, Canada
Completed
University of Minnesota PhysiciansMinneapolis, 55455, United States
Terminated
Hopital Charles LeMoyneGreenfield Park, J4V 2H1, Canada
Terminated
University of Arizona Cancer CenterTucson, 85724, United States
Completed
Cancer Care Specialists of Central IllinoisDecatur, 62526, United States

Primary Outcome

  • Response to treatment with ZK-Epo after 6 cycles
    date_rangeTime Frame:
    complete or partial response after 2 to 6 courses of therapy.
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    Safety Issue:
    no

Secondary Outcome

  • Safety and tolerability of ZK-Epo
    date_rangeTime Frame:
    time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.
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    Safety Issue:
    yes

Trial design

Phase 2 study to investigate the efficacy and safety of ZK-Epothilone (ZK-Epo; ZK 219477) in patients with metastatic breast cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
2

Additional Information

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