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

This study has been terminated.
(poor enrollment)
Information provided by (Responsible Party):
KangLaiTe USA Identifier:
First received: June 15, 2012
Last updated: January 15, 2014
Last verified: January 2014

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
Drug: Kanglaite Injection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bioimpedance Phase Angle [ Time Frame: measured each month up to one year ] [ Designated as safety issue: No ]
  • Palliation Response Measure [ Time Frame: each month up to one year ] [ Designated as safety issue: No ]
    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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01640730

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

No publications provided

Responsible Party: KangLaiTe USA Identifier: NCT01640730     History of Changes
Other Study ID Numbers: KLT-NSCLC-004
Study First Received: June 15, 2012
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on November 27, 2014