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

Stage IV NSCLC Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01640730
• Other study ID #: KLT-NSCLC-004
• Status: Terminated
• Phase: Phase 2
• First received: June 15, 2012
• Last updated: January 15, 2014
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: January 2014
• Source: KangLaiTe USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stage IV NSCLC

Intervention

Drug:
• Kanglaite Injection
30gm IV infusion 5 days a week for 3 weeks every 28 days

Locations

Country	Name	City	State
United States	The West Clinic	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
KangLaiTe USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		from date of enrollment until date of death from any cause assessed up to 12 months	No
Secondary	Bioimpedance Phase Angle		measured each month up to one year	No
Secondary	Palliation Response Measure	quality of life survey and performance status	each month up to one year	No