Trial Condition(s):
Breast Neoplasm
Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
Bayer Identifier:
91466
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations M. D. Anderson Cancer Center - University of Texas Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Care Center, Inc. New Albany, United States, 47150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alabama at Birmingham Birmingham, United States, 35233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Georgetown University Medical Center Washington, United States, 20007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Genesis Cancer Center Hot Springs, United States, 71913 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital du St-Sacrement Quebec, Canada, G1S 4L8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Greater Baltimore Medical Center Baltimore, United States, 21204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Halifax Health Medical Center Daytona Beach, United States, 32114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tacoma General Hospital Tacoma, United States, 98405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Comprehensive Blood and Cancer Center Bakersfield, United States, 93309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Comprehensive Cancer Center Palm Springs, United States, 92262 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Weill Cornell Breast Center New York, United States, 10021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Texas Oncology & Hematology, P.A. San Antonio, United States, 78207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Alaska Cancer Research and Education Center Anchorage, United States, 99508 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saint Barnabas Medical Center Livingston, United States, 07039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Health and Science University Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SUNY Upstate Medical University Syracuse, United States, 13210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Colorado Hospital Aurora, United States, 80010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Magee Womens Hospital of UPMC Pittsburgh, United States, 15213-3180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Minnesota Physicians Minneapolis, United States, 55455 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Charles LeMoyne Greenfield Park, Canada, J4V 2H1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Arizona Cancer Center Tucson, United States, 85724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Care Specialists of Central Illinois Decatur, United States, 62526 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Response to treatment with ZK-Epo after 6 cyclesTimeframe: complete or partial response after 2 to 6 courses of therapy.
Secondary Outcome
- Safety and tolerability of ZK-EpoTimeframe: time to progression after start of study treatment and response duration from time between first date of confirmed PR or CR.
Additional Information
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