Trial Condition(s):
Ovarian Neoplasms
ZK-Epo given with carboplatin in patients with recurrent ovarian cancer
Bayer Identifier:
91476
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) 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Albuquerque, United States, 87131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Little Rock, United States, 72205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4N 3M5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Savannah, United States, 31404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roanoke, United States, 24014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bakersfield, United States, 93309 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T2N 4N2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baltimore, United States, 21204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Knoxville, United States, 37920 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site South Bend, United States, 46617 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92121 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucson, United States, 85724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Jolla, United States, 92093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Phase 1/2 study of ZK-Epothilone (ZK-Epo; ZK-219477) in combination with carboplatin in patients with platinum-sensitive recurrent ovarian cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Response to treatment with ZK-Epo after 6 cyclesTimeframe: After 6 cycles
Secondary Outcome
- Safety and tolerability of ZK-Epo given with carboplatinTimeframe: Sept. 2008
Additional Information
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