Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031031
Status:
COMPLETED
Last Update Posted:
2007-11-27
First Post:
2002-02-20
Brief Title:
Kanglaite Injection Phase I Study
Sponsor:
KangLaiTe USA
Organization:
KangLaiTe USA
Study Overview
Official Title:
Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Kanglaite Injection KLTis a novel broad spectrum anti-cancer injection produced from traditional Chinese medicinal herbs the Coix Seed It was approved in China in 1995 and has become the most popular anti-cancer drug in China In June of 2001 the Phase I study of KLT commenced at the Huntsman Cancer Institute in Salt Lake City Utah with the objectives of 1 To determine the maximum tolerated dose MTD and the safety profile of KLT in patients with refractory solid tumors 2 To determine the pharmacokinetics of KLT in patients with refractory solid tumors and 3 To gather preliminary efficacy data The method of testing is open-label sequential cohort dose-escalation study
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