Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
2 other identifiers
interventional
65
2 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2006
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 12, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedDecember 10, 2015
November 1, 2015
2.5 years
April 11, 2006
November 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment with ZK-Epo after 6 cycles
complete or partial response after 2 to 6 courses of therapy.
Secondary Outcomes (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.
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALInterventions
All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (25)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Anchorage, Alaska, 99508, United States
Unknown Facility
Tucson, Arizona, 85724, United States
Unknown Facility
Hot Springs, Arkansas, 71913, United States
Unknown Facility
Bakersfield, California, 93309, United States
Unknown Facility
Palm Springs, California, 92262, United States
Unknown Facility
Aurora, Colorado, 80010, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Daytona Beach, Florida, 32114, United States
Unknown Facility
Decatur, Illinois, 62526, United States
Unknown Facility
New Albany, Indiana, 47150, United States
Unknown Facility
Baltimore, Maryland, 21204, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Livingston, New Jersey, 07039, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Syracuse, New York, 13210, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213-3180, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78207, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Unknown Facility
Toronto, Ontario, M4N 3M5, Canada
Unknown Facility
Greenfield Park, Quebec, J4V 2H1, Canada
Unknown Facility
Montreal, Quebec, H3T 1E2, Canada
Unknown Facility
Québec, Quebec, G1S 4L8, Canada
Related Publications (1)
Morrow PK, Divers S, Provencher L, Luoh SW, Petrella TM, Giurescu M, Schmelter T, Wang Y, Hortobagyi GN, Vahdat LT. Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. Breast Cancer Res Treat. 2010 Oct;123(3):837-42. doi: 10.1007/s10549-010-1102-x. Epub 2010 Aug 10.
PMID: 20697802DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2006
First Posted
April 12, 2006
Study Start
April 1, 2006
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
December 10, 2015
Record last verified: 2015-11