Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-03-03 @ 5:03 PM
Study NCT ID:
NCT02734433
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pexidartinib in Asian Subjects With Advanced Solid Tumors
Sponsor:
Daiichi Sankyo Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1 Study of Single Agent Pexidartinib in Asian Subjects With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-03
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 is a Phase I, non-randomized, open-label, multiple dose study of pexidartinib in Asian subjects with advanced solid tumors. The study will be conducted in a dose escalation to assess the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD), and preliminary antitumor activity of pexidartinib.
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?:
True
Is an FDA AA801 Violation?: