Ignite Creation Date:
2024-05-06 @ 4:05 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02442414
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2015-04-29
Brief Title:
A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors
Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd
Organization:
Sihuan Pharmaceutical Holdings Group Ltd
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2022-02
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 determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy or where there is no standard therapy
Detailed Description:
This is a Phase 1 open-label multicenter study of KBP-5209 administered orally once daily QD in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists This study is designed to determine the MTD or RP2D and to characterize the safety tolerability and PK profile of KBP-5209
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