Safety and Exploratory Efficacy of Kanglaite Injection in... | NCT01640730

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

NCT01640730

Sponsor

KangLaiTe USA

Status

Terminated

Last Update Posted

Jan 16, 2014Estimated

Enrollment

1Actual

Phase

Phase 2

Conditions

Stage IV NSCLC

Interventions

Kanglaite Injection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

poor enrollment

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Jun 15, 2012

First Submission Date that Met QC Criteria

Jul 11, 2012

First Posted Date

Jul 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2014

Last Update Posted Date

Jan 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kanglaite injection	Experimental		Drug: Kanglaite Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kanglaite Injection	Drug	30gm IV infusion 5 days a week for 3 weeks every 28 days	Kanglaite injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival		from date of enrollment until date of death from any cause assessed up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Bioimpedance Phase Angle		measured each month up to one year
Palliation Response Measure	quality of life survey and performance status	each month up to one year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The West Clinic		Memphis	Tennessee	38120	United States

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C499781	kang-lai-te

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided