Trial Information
Phase 1/2 Study of ZK-Epothilone (ZK-Epo; ZK-219477) in Combination With Carboplatin in Patients With Platinum-sensitive Recurrent Ovarian 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 sponsoring
this trial.
Inclusion Criteria:
- 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 Criteria:- 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
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:
After 6 cycles
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
United States: Food and Drug Administration
Study ID:
91476
NCT ID:
NCT00325351
Start Date:
August 2006
Completion Date:
March 2009
Related Keywords:
- Ovarian Neoplasms
- Ovarian cancer
- Ovarian neoplasms, epithelium
- Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|
|
Albany, Georgia 31701 |
|
Phoenix, Arizona 85012 |
|
Fountain Valley, California 92708 |
|
Cleveland, Ohio 44195 |
|
Nashville, Tennessee 37203-1632 |
|
McLean, Virginia 22101 |
|
Little Rock, Arkansas 72205-7199 |
|
Albuquerque, New Mexico 87131-5636 |
|
Baltimore, Maryland 21287 |
|
Charlotte, North Carolina |
|
Indianapolis, Indiana |
|
Tulsa, Oklahoma |
