Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
18 Years
N/A
Female
Breast Neoplasm
Trial Information
Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response to treatment with ZK-Epo after 6 cycles
Outcome Time Frame:
complete or partial response after 2 to 6 courses of therapy.
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United States: Food and Drug Administration
Study ID:
91466
NCT ID:
NCT00313248
Start Date:
March 2006
Completion Date:
November 2008
Related Keywords:
- Breast Neoplasm
- Breast Cancer
- Metastatic Breast Cancer
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Alexandria, Minnesota 56308 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Little Rock, Arkansas 72205-7199 | |
| Hackensack, New Jersey 07601 | |
| Anchorage, Alaska | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Eugene, Oregon | |
| Indianapolis, Indiana | |
| Washington, District of Columbia |
