ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 45 for:    herbal medicine | United States

Kanglaite Injection Phase I Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00031031
Recruitment Status : Completed
First Posted : February 22, 2002
Last Update Posted : November 27, 2007
Sponsor:
Information provided by:
KangLaiTe USA

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 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
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

ClinicalTrials.gov Identifier: NCT00031031     History of Changes
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