Kanglaite Injection Phase I Study

Completed · Phase 1

Conditions studied: Solid Tumors Refractory To Standard Therapy, Neoplasms

In brief

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.

Key facts

Study ID
NCT00031031
Run by
KangLaiTe USA
People needed
16
Starts
2001-06-01
Expected to finish
2002-11-01
Last updated by the study team
2007-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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