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Trial record 5 of 7 for:    Kanglaite injection
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Kanglaite Injection Phase I Study

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ClinicalTrials.gov Identifier: NCT00031031
Recruitment Status : Completed
First Posted : February 22, 2002
Last Update Posted : November 27, 2007
Sponsor:
Information provided by:
KangLaiTe USA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumors Refractory To Standard Therapy Neoplasms Drug: Kanglaite Injection (KLT) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy
Study Start Date : June 2001
Actual Study Completion Date : November 2002
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031031


Locations
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United States, Utah
Huntsman Cancer Institue
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
KangLaiTe USA
Investigators
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Principal Investigator: Richard H Wheeler, M.D. Huntsman Cancer Institute
More Information
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ClinicalTrials.gov Identifier: NCT00031031    
Other Study ID Numbers: KN-001-01
First Posted: February 22, 2002    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007
Keywords provided by KangLaiTe USA:
MTD
Safety
Pharmacokinetics
Efficacy