NCT00031031

Kanglaite Injection Phase I Study

Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: KangLaiTe USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Kanglaite Injection (KLT)is 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.

Conditions

• Solid Tumors Refractory To Standard Therapy
• Neoplasms

Interventions

Type	Name	Description
DRUG	Kanglaite Injection (KLT)

Timeline

• Start date: 2001-06-01
• Completion: 2002-11-01
• First posted: 2002-02-22
• Last updated: 2007-11-27

Locations

1 site across 1 country: United States