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

This study has been terminated.
(poor enrollment)
Sponsor:
Information provided by (Responsible Party):
KangLaiTe USA
ClinicalTrials.gov Identifier:
NCT01640730
First received: June 15, 2012
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Stage IV NSCLC
 Drug: Kanglaite Injection
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by KangLaiTe USA:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: from date of enrollment until date of death from any cause assessed up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bioimpedance Phase Angle [ Time Frame: measured each month up to one year ] [ Designated as safety issue: No ]
  • Palliation Response Measure [ Time Frame: each month up to one year ] [ Designated as safety issue: No ]
    quality of life survey and performance status


Enrollment: 1
Study Start Date: May 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kanglaite injection Drug: Kanglaite Injection
30gm IV infusion 5 days a week for 3 weeks every 28 days
Other Name: KLTi

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640730

Locations
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
KangLaiTe USA
  More Information

No publications provided

Responsible Party: KangLaiTe USA
ClinicalTrials.gov Identifier: NCT01640730     History of Changes
Other Study ID Numbers: KLT-NSCLC-004
Study First Received: June 15, 2012
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013