Status:
COMPLETED
ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer
Lead Sponsor:
Bayer
Conditions:
Ovarian Neoplasms
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) given with carboplatin in patients with recurrent ovarian cancer, who previously have had a goo...
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 sponsoring this trial.
Eligibility Criteria
Inclusion
- Must have evidence of ovarian cancer measurable by computed tomography (CT) scan or by CA125 blood levels- No radiation therapy in last 4 weeks- No chemotherapy in last 24 weeks - No immunotherapy in last 4 weeks- Good response after previous treatment with carboplatin or cisplatin and then the ovarian cancer got worse again after at least 6 months- Additional criteria determined at screening visit
Exclusion
- Having had more than one treatment regimen with carboplatin or cisplatin- Prior treatment with other epothilones (e.g. ixabepilone)- Use of any investigational drug in the last 4 weeks- Previous radiation to the whole pelvis- Symptomatic brain tumors requiring radiation to the brain - Active infection- Pregnant or breast feeding- Additional criteria determined at screening visit
Key Trial Info
Start Date :
August 24 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00325351
Start Date
August 24 2006
End Date
March 25 2009
Last Update
April 8 2021
Active Locations (16)
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1
Tucson, Arizona, United States, 85724
2
Little Rock, Arkansas, United States, 72205
3
Bakersfield, California, United States, 93309
4
La Jolla, California, United States, 92093