ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer
Phase 1/2 Study of ZK-Epothilone (ZK-Epo; ZK-219477) in Combination With Carboplatin in Patients With Platinum-sensitive Recurrent Ovarian Cancer
2 other identifiers
interventional
45
2 countries
16
Brief Summary
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a good response with cisplatin or carboplatin, is safe and 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 P25-P50 for phase_2
Started Aug 2006
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2006
CompletedFirst Posted
Study publicly available on registry
May 12, 2006
CompletedStudy Start
First participant enrolled
August 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2009
CompletedApril 8, 2021
April 1, 2021
1.9 years
May 11, 2006
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to treatment with ZK-Epo after 6 cycles
After 6 cycles
Secondary Outcomes (1)
Safety and tolerability of ZK-Epo given with carboplatin
Sept. 2008
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (16)
Unknown Facility
Tucson, Arizona, 85724, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Bakersfield, California, 93309, United States
Unknown Facility
La Jolla, California, 92093, United States
Unknown Facility
San Diego, California, 92121, United States
Unknown Facility
Savannah, Georgia, 31404, United States
Unknown Facility
South Bend, Indiana, 46617, United States
Unknown Facility
Baltimore, Maryland, 21204, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Cleveland, Ohio, 44109, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Unknown Facility
Roanoke, Virginia, 24014, United States
Unknown Facility
Calgary, Alberta, T2N 4N2, Canada
Unknown Facility
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
McMeekin S, Patel R, Verschraegen C, Celano P, Burke J 2nd, Plaxe S, Ghatage P, Giurescu M, Stredder C, Wang Y, Schmelter T. Phase I/II study of sagopilone (ZK-EPO) plus carboplatin in women with recurrent platinum-sensitive ovarian cancer. Br J Cancer. 2012 Jan 3;106(1):70-6. doi: 10.1038/bjc.2011.499. Epub 2011 Nov 22.
PMID: 22108514RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
May 11, 2006
First Posted
May 12, 2006
Study Start
August 24, 2006
Primary Completion
July 8, 2008
Study Completion
March 25, 2009
Last Updated
April 8, 2021
Record last verified: 2021-04