Safety and Exploratory Efficacy of Kanglaite Injection in Non Small Cell Lung Cancer

January 15, 2014 updated by: KangLaiTe USA

An Open Label Safety and Exploratory Efficacy Study of Kanglaite Injection in Patients Having Progressive Stage IV NSCLC Who Are Not Candidates for Other Anti-cancer Treatment

This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • confirmed (within last 3 months)progressive Stage IV NSCLC
  • estimated life span of 3 months
  • phase angle of at least 5 as measured by bioimpedance

Exclusion Criteria:

  • currently taking a lipid lowering medications
  • has an imminently life threatening condition
  • has pre-existing liver disease
  • known allergy to soybeans
  • uncontrolled diabetes or uncontrolled disturbance of lipid metabolism
  • pregnant or lactating
  • has a pacemaker or other implantable electronic medical device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kanglaite injection
Drug: Kanglaite Injection
30gm IV infusion 5 days a week for 3 weeks every 28 days
Other Names:
  • KLTi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: from date of enrollment until date of death from any cause assessed up to 12 months
from date of enrollment until date of death from any cause assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioimpedance Phase Angle
Time Frame: measured each month up to one year
measured each month up to one year
Palliation Response Measure
Time Frame: each month up to one year
quality of life survey and performance status
each month up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KangLaiTe USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 16, 2012

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • KLT-NSCLC-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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