Status:
COMPLETED
Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
Lead Sponsor:
Bayer
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00313248
Start Date
April 1 2006
End Date
November 1 2008
Last Update
December 10 2015
Active Locations (25)
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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