Study Stopped
poor enrollment
Safety and Exploratory Efficacy of Kanglaite Injection in Non Small Cell Lung Cancer
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
1 other identifier
interventional
1
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 15, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJanuary 16, 2014
January 1, 2014
5 months
June 15, 2012
January 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
from date of enrollment until date of death from any cause assessed up to 12 months
Secondary Outcomes (2)
Bioimpedance Phase Angle
measured each month up to one year
Palliation Response Measure
each month up to one year
Study Arms (1)
Kanglaite injection
EXPERIMENTALInterventions
30gm IV infusion 5 days a week for 3 weeks every 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KangLaiTe USAlead
Study Sites (1)
The West Clinic
Memphis, Tennessee, 38120, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2012
First Posted
July 16, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
January 16, 2014
Record last verified: 2014-01