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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01640730
Recruitment Status : Terminated (poor enrollment)
First Posted : July 16, 2012
Last Update Posted : January 16, 2014
Information provided by (Responsible Party):
KangLaiTe USA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage IV NSCLC Drug: Kanglaite Injection Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Kanglaite injection Drug: Kanglaite Injection
30gm IV infusion 5 days a week for 3 weeks every 28 days
Other Name: KLTi

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: from date of enrollment until date of death from any cause assessed up to 12 months ]

Secondary Outcome Measures :
  1. Bioimpedance Phase Angle [ Time Frame: measured each month up to one year ]
  2. Palliation Response Measure [ Time Frame: each month up to one year ]
    quality of life survey and performance status

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01640730

United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
KangLaiTe USA

Responsible Party: KangLaiTe USA Identifier: NCT01640730     History of Changes
Other Study ID Numbers: KLT-NSCLC-004
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014