Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-04-04 @ 10:09 PM
Study NCT ID:
NCT02133157
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2014-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
Sponsor:
Hutchison Medipharma Limited
Organization:
Study Overview
Official Title:
Phase I Study of Safety and Pharmacokinetics of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2020-07
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:
HMPL
Brief Summary:
Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has demonstrated potent inhibitory effects on multiple human tumor xenografts. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor activity of HMPL-012 at single doses and multiple doses .
Detailed Description:
This will be an open-label, phase I study. This study will evaluate the safety and pharmacokinetics of HMPL-012 after a single administration followed by a 28-Day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-label administration of at the MTD. All subjects of this study will be permitted to continue therapy with only safety monitoring and monthly assessments for progression, if the product is well tolerated and the subject has stable disease or better
Study Oversight
Has Oversight DMC:
True
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?: