Ignite Creation Date:
2024-05-05 @ 9:58 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01004861
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2009-10-28
Brief Title:
Safety Study of PLX108-01 in Patients With Solid Tumors
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1 Study to Assess Safety Pharmacokinetics and Pharmacodynamics of PLX3397 in Patients With Advanced Incurable Solid Tumors in Which the Target Kinases Are Linked to Disease Pathophysiology
Status:
COMPLETED
Status Verified Date:
2021-12
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:
PLX3397 is a selective inhibitor of Fms Kit and oncogenic Flt3 activity The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced incurable solid tumors in which these target kinases are linked to disease pathophysiology The secondary objective is to measure the pharmacodynamic activity of PLX3397 via blood plasma and urine biomarkers of Fms activity
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