Kanglaite Injection Phase I Study

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.

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Key information

Conditions

Solid Tumors Refractory to Standard Therapy Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huntsman Cancer Institue

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kanglaite Injection (KLT)

Drug

Sponsors and collaborators

Lead sponsor

KangLaiTe USA

Industry

Registry information

Official study title

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

Important dates

Study start: 2001
Study completion: 2002
First posted: Feb 22, 2002
Registry last updated: Nov 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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