Kanglaite Injection Phase I Study

First Submitted Date ICMJE February 20, 2002
First Posted Date ICMJE February 22, 2002
Last Update Posted Date November 27, 2007
Study Start Date ICMJE June 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures ICMJE Not Provided
Original Primary Outcome Measures ICMJE Not Provided
Change History Complete list of historical versions of study NCT00031031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE Not Provided
Original Secondary Outcome Measures ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided

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 Not Provided
Study Type ICMJE Interventional
Study Phase ICMJE Phase 1
Study Design ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition ICMJE
Solid Tumors Refractory To Standard Therapy
Neoplasms
Intervention ICMJE Drug: Kanglaite Injection (KLT)
Study Arms ICMJE Not Provided
Publications * Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ICMJE Completed
Actual Enrollment ICMJE
(submitted: November 26, 2007) 16
Original Enrollment ICMJE
(submitted: June 23, 2005) 18
Actual Study Completion Date ICMJE November 2002
Primary Completion Date Not Provided
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
Sex/Gender ICMJE
Sexes Eligible for Study: All
Ages ICMJE 18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers ICMJE No
Contacts ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE United States
Removed Location Countries

Administrative Information
NCT Number ICMJE NCT00031031
Other Study ID Numbers ICMJE KN-001-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor ICMJE KangLaiTe USA
Collaborators ICMJE Not Provided
Investigators ICMJE
Principal Investigator: Richard H Wheeler, M.D. Huntsman Cancer Institute
PRS Account KangLaiTe USA
Verification Date November 2007

Philadelphia, USA