NCT00031031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2002

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

February 20, 2002

Last Update Submit

November 26, 2007

Conditions

Solid Tumors Refractory To Standard TherapyNeoplasms

Keywords

MTDSafetyPharmacokineticsEfficacy

Interventions

Kanglaite Injection (KLT)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institue

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

kang-lai-te

Study Officials

  • Richard H Wheeler, M.D.

    Huntsman Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 20, 2002

First Posted

February 22, 2002

Study Start

June 1, 2001

Study Completion

November 1, 2002

Last Updated

November 27, 2007

Record last verified: 2007-11

Locations

US(1)