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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Stage IV NSCLC
Both
Stage IV NSCLC
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
from date of enrollment until date of death from any cause assessed up to 12 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
KLT-NSCLC-004
NCT ID:
NCT01640730
Start Date:
May 2012
Completion Date:
Related Keywords:
- Stage IV NSCLC
- Carcinoma, Non-Small-Cell Lung
Name | Location |
|---|---|
| The West Clinic | Memphis, Tennessee 38120 |
