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| Sponsored by: |
KangLaiTe USA |
| Information provided by: | KangLaiTe USA |
| ClinicalTrials.gov Identifier: | NCT00031031 |
Purpose
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 | Intervention | Phase |
|
Solid Tumors Refractory To Standard Therapy Neoplasms |
Drug: Kanglaite Injection (KLT) |
Phase I |
| MedlinePlus related topics: | Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| United States, Utah | |||||
| Huntsman Cancer Institue | |||||
| Salt Lake City, Utah, United States, 84112 | |||||
| KangLaiTe USA |
| Principal Investigator: | Richard H Wheeler, M.D. | Huntsman Cancer Institute |
More Information
| Study ID Numbers: | KN-001-01 |
| First Received: | February 20, 2002 |
| Last Updated: | November 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00031031 |
| Health Authority: | United States: Food and Drug Administration |
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