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

Phase 2TerminatedNCT01640730

KangLaiTe USA1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stage IV NSCLC

Interventions

Kanglaite InjectionDRUG

30gm IV infusion 5 days a week for 3 weeks every 28 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The West Clinic

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Overall Survival

Time frame: from date of enrollment until date of death from any cause assessed up to 12 months

Secondary Outcomes

Bioimpedance Phase Angle

Time frame: measured each month up to one year

Palliation Response Measure

quality of life survey and performance status

Time frame: each month up to one year

Data from ClinicalTrials.gov

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