Kanglaite Injection Phase I Study

Neoplasms Clinical Trial

Official title:

Phase I Study of KLT in Patients With Solid Tumors Refractory to Standard Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031031
• Other study ID #: KN-001-01
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2002
• Last updated: November 26, 2007
• Start date: June 2001
• Est. completion date: November 2002

Study information

• Verified date: November 2007
• Source: KangLaiTe USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors Refractory To Standard Therapy

Intervention

Drug:
• Kanglaite Injection (KLT)

Locations

Country	Name	City	State
United States	Huntsman Cancer Institue	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
KangLaiTe USA

Country where clinical trial is conducted

United States,