Kanglaite Injection Phase I Study - Full Text View

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	KN-001-01
Study First Received:	February 20, 2002
Last Updated:	November 26, 2007
ClinicalTrials.gov Identifier:	NCT00031031 History of Changes
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 27, 2009