Kanglaite Injection Phase I Study - Tabular View

Tracking Information

First Received Date ^ICMJE

February 20, 2002

Last Updated Date

November 26, 2007

Start Date ^ICMJE

June 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00031031 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Kanglaite Injection Phase I Study

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Solid Tumors Refractory To Standard Therapy
Neoplasms

Intervention ^ICMJE

Drug: Kanglaite Injection (KLT)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00031031

Responsible Party

Study ID Numbers ^ICMJE

KN-001-01

Study Sponsor ^ICMJE

KangLaiTe USA

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Richard H Wheeler, M.D.

Huntsman Cancer Institute

Information Provided By

KangLaiTe USA

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP