Status:
COMPLETED
Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill")
Lead Sponsor:
Eli Lilly and Company
Conditions:
Ovarian Cancer
Fallopian Tube Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Participants with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many participants the tumor will shrink, or even disappear, after treatment with these drugs....
Eligibility Criteria
Inclusion
- Participants must have specific stages of disease, known as Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stages IIB, IIC, III or IV
- Organ functions (blood, renal, liver, cardiac) must meet specific requirements.
- Participants who could become pregnant must take care not to become pregnant during the study participation and for 6 months after study discontinuation
- Participants must give written consent for study participation.
Exclusion
- Participants received any experimental drug within the last 30 days.
- Participants received any prior chemotherapy or other drug therapy for the current disease.
- Participants receive any other treatment for the cancer during study participation.
- Participants are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.
- Participants are pregnant, breast feeding, or not using adequate contraceptive methods to prevent pregnancy.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00391118
Start Date
November 1 2006
End Date
July 1 2012
Last Update
October 19 2020
Active Locations (15)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leuven, Belgium, 3000
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Liège, Belgium, 4000
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Berlin, Germany, 13353
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Düsseldorf, Germany, 40489