Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02435433
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2015-05-01
Brief Title:
A Study of Ramucirumab LY3009806 Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Phase 3 Study of Ramucirumab and Best Supportive Care BSC Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein AFP Following First-Line Therapy With Sorafenib
Status:
COMPLETED
Status Verified Date:
2022-12-01
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:
REACH-2
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma HCC and elevated baseline alpha-fetoprotein Participants will be randomized to ramucirumab or placebo in a 21 ratio Main Global Cohort and China Maximized Extended Enrollment MEE Cohort Participants may also receive ramucirumab if eligible to be enrolled in Open-Label Expansion OLE Cohort
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 |
|---|---|---|---|
| 2014-005068-13 | EUDRACT_NUMBER | Eli Lilly and Company | None |
| I4T-MC-JVDE | OTHER | None | None |