Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-01-01 @ 10:01 AM
Study NCT ID:
NCT00709995
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2008-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study for Participants With Metastatic Renal Cell Carcinoma
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
Dose Finding and Randomized, Multicenter, Placebo-Controlled, Phase 2 Study of Enzastaurin and Sunitinib Versus Placebo and Sunitinib in Patients With Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-01
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:
This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.
Detailed Description:
This is a multicenter, Phase 2 study of enzastaurin and sunitinib versus placebo and sunitinib as first-line therapy in participants with metastatic renal cell carcinoma, containing 2 parts. Part 1 is a safety lead-in study with 12 participants and possible dose escalation. Part 2 is a randomized, double-blind, Phase 2 study in 110 participants.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| H6Q-MC-S061 | OTHER | Eli Lilly and Company | View |