Kanglaite Injection Phase I Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Solid Tumors Refractory To Standard Therapy Neoplasms	Drug: Kanglaite Injection (KLT)	Phase I

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by KangLaiTe USA:

Enrollment:	16
Study Start Date:	June 2001
Study Completion Date:	November 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031031

Locations


United States, Utah
	Huntsman Cancer Institue
	Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

KangLaiTe USA

Investigators


Principal Investigator:	Richard H Wheeler, M.D.	Huntsman Cancer Institute

More Information

Study ID Numbers:	KN-001-01
First Received:	February 20, 2002
Last Updated:	November 26, 2007
ClinicalTrials.gov Identifier:	NCT00031031
Health Authority:	United States: Food and Drug Administration

Keywords provided by KangLaiTe USA:

MTD

Safety

Pharmacokinetics

Efficacy

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	KangLaiTe USA
Information provided by:	KangLaiTe USA
ClinicalTrials.gov Identifier:	NCT00031031