We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 6 for:    kanglaite

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

This study has been terminated.
(poor enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640730
First Posted: July 16, 2012
Last Update Posted: January 16, 2014
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.
Information provided by (Responsible Party):
KangLaiTe USA
  Purpose
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 Intervention Phase
Stage IV NSCLC Drug: Kanglaite Injection Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by KangLaiTe USA:

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

Secondary Outcome Measures:
  • Bioimpedance Phase Angle [ Time Frame: 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


Enrollment: 1
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kanglaite injection Drug: Kanglaite Injection
30gm IV infusion 5 days a week for 3 weeks every 28 days
Other Name: KLTi

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01640730


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

Responsible Party: KangLaiTe USA
ClinicalTrials.gov Identifier: NCT01640730     History of Changes
Other Study ID Numbers: KLT-NSCLC-004
First Submitted: June 15, 2012
First Posted: July 16, 2012
Last Update Posted: January 16, 2014
Last Verified: January 2014