Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391118
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2006-10-19
Brief Title:
Comparing Two Treatments for Ovarian Cancer Standard Chemotherapy Plus Enzastaurin or Placebo Sugar Pill
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 But unfortunately the tumor will grow again in many participants 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 participants 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 Participants and physicians will not know if a participant gets enzastaurin or placebo double-blinded trial After a predefined time the treatment will be uncovered and the number of participants with tumor growth at a specific time point will be compared between the two treatments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H6Q-MC-S019 | OTHER | Eli Lilly and Company | None |