Kanglaite Injection Phase I Study

Zhejiang Kanglaite Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Solid Tumors Refractory To Standard Therapy

Treatments

Drug: Kanglaite Injection (KLT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00031031

KN-001-01

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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