Kanglaite Injection Phase I Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2002-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors Refractory To Standard Therapy Neoplasms

Keywords

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MTD Safety Pharmacokinetics Efficacy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Kanglaite Injection (KLT)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Richard H Wheeler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute

Locations

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Huntsman Cancer Institue

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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KN-001-01

Identifier Type: -

Identifier Source: org_study_id