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| Sponsored by: |
Eli Lilly and Company |
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00391118 |
Purpose
Patients with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many patients the tumor will shrink, or even disappear, after treatment with these drugs. But, unfortunately, the tumor will grow again in many patients. This trial will try to address the question: Can we delay the time, till the tumor grows again, by adding a 3rd drug to the standard therapy? To answer this question, patients will, by chance, either get the experimental drug enzastaurin or a "dummy pill" (placebo) during the chemotherapy and for up to 3 years after chemotherapy. Patients and physicians will not know, if a patient gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment will be uncovered, and the number of patients with tumor growth at a specific time point will be compared between the two treatments.
| Condition | Intervention | Phase |
|
Ovarian Cancer Fallopian Tube Neoplasms Peritoneal Neoplasm |
Drug: enzastaurin Drug: carboplatin Drug: paclitaxel Drug: placebo |
Phase II |
| MedlinePlus related topics: | Cancer Ovarian Cancer |
| ChemIDplus related topics: | Carboplatin Paclitaxel Enzastaurin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Phase 2, Placebo-Controlled, Double-Blinded Study With and Without Enzastaurin in Combination With Paclitaxel and Carboplatin as First-Line Treatment, Followed by Maintenance Treatment in Advanced Ovarian Cancer |
| Estimated Enrollment: | 149 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| A: Experimental |
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, six 21 day cycles or up to 3 years
Drug: carboplatin
AUC 5, IV, q 21 days, six 21 day cycles
Drug: paclitaxel
175 mg/m2, IV, q 21 days, six 21 day cycles
|
| B: Placebo Comparator |
Drug: carboplatin
AUC 5, IV, q 21 days, six 21 day cycles
Drug: paclitaxel
175 mg/m2, IV, q 21 days, six 21 day cycles
Drug: placebo
oral, daily
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
| Belgium | |||||
| 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. | Recruiting | ||||
| Leuven, Belgium, 3000 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Liege, Belgium, 4000 | |||||
| Contact: Eli Lilly | |||||
| Germany | |||||
| 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. | Recruiting | ||||
| Berlin, Germany, 13353 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Duesseldorf, Germany, 40489 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Erlangen, Germany, D-91054 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Wiesbaden, Germany, D-65199 | |||||
| Contact: Eli Lilly | |||||
| Poland | |||||
| 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. | Recruiting | ||||
| Gdansk, Poland, 80-402 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Warsaw, Poland, 02-781 | |||||
| Contact: Eli Lilly | |||||
| Russian Federation | |||||
| 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. | Recruiting | ||||
| Ivanovo, Russian Federation, 153040 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Kazan, Russian Federation, 420029 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Moscow, Russian Federation, 115478 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Stavropol, Russian Federation, 355047 | |||||
| Contact: Eli Lilly | |||||
| Spain | |||||
| 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. | Recruiting | ||||
| Barcelona, Spain, 08035 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Madrid, Spain, 28041 | |||||
| Contact: Eli Lilly | |||||
| 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. | Recruiting | ||||
| Valencia, Spain, 46010 | |||||
| Contact: Eli Lilly | |||||
| Eli Lilly and Company |
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Lilly Clinical Trial Registry 
  |
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 10708, H6Q-MC-S019 |
| First Received: | October 19, 2006 |
| Last Updated: | June 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00391118 |
| Health Authority: | United States: Food and Drug Administration; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Germany: Federal Institute for Drugs and Medical Devices |
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