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Clinical Trials/NCT01640730
NCT01640730
Terminated
Phase 2

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

KangLaiTe USA1 site in 1 country1 target enrollmentMay 2012
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ConditionsStage IV NSCLC
InterventionsKanglaite Injection
DrugsKanglaite Injection

Overview

Phase
Phase 2
Intervention
Kanglaite Injection
Conditions
Stage IV NSCLC
Sponsor
KangLaiTe USA
Enrollment
1
Locations
1
Primary Endpoint
Overall Survival
Status
Terminated
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
October 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
KangLaiTe USA
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Kanglaite injection

Intervention: Kanglaite Injection

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(measured each month up to one year)
  • Palliation Response Measure(each month up to one year)

Study Sites (1)

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