Trial | NCT00031031  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    kanglaite ...

  • Study Participants

    16
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.
Study Started
Jun 30
2001
Study Completion
Nov 30
2002
Last Update
Nov 27
2007
Estimate

Drug Kanglaite Injection (KLT)

Criteria 

Patients with histological evidence of malignancy that has become refractory to standard therapy, or for whom effective standard therapy does not exist.
Patients with an estimated life-expectancy of at least 3 months
Patients with a Karnofsky Performance Score of at least 60%
Patients with no history of congestive heart failure (CHF), and normal ejection fraction by echocardiography
Patients with adequate renal and hepatic function
Patients with adequate bone marrow status
No Results Posted