Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-04 @ 5:57 PM
Study NCT ID:
NCT01055067
Status:
TERMINATED
Last Update Posted:
2021-04-06
First Post:
2010-01-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
Multicenter Phase 2 Trial of ARQ 197 for Subjects With Relapsed or Refractory Germ Cell Tumors
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early for futility according to the stopping rule of the Simon 2-stage design.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter, single-arm study for safety and efficacy.
Detailed Description:
None
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?: