- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00031031
Kanglaite Injection Phase I Study
November 26, 2007 updated by: KangLaiTe USA
Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institue
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard H Wheeler, M.D., Huntsman Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Study Completion (Actual)
November 1, 2002
Study Registration Dates
First Submitted
February 20, 2002
First Submitted That Met QC Criteria
February 21, 2002
First Posted (Estimate)
February 22, 2002
Study Record Updates
Last Update Posted (Estimate)
November 27, 2007
Last Update Submitted That Met QC Criteria
November 26, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KN-001-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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