Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 10:24 AM
Study NCT ID:
NCT02678260
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of PDR001 in Patients With Advanced Malignancies.
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2018-06
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:
The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: