Blood Brain Barrier Penetration and Pharmacokinetics of t... | NCT01679847

Studies
Blood Brain Barrier Penetration and Pharmacokinetics of the Elemene in Malignant Patients.

NCT01679847

Sponsor

Dalian Holley Kingkong Pharmaceutical Co., Ltd

Status

Unknown status

Last Update Posted

Sep 10, 2012Estimated

Enrollment

8Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Not provided

Countries

China

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

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Apr 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Sep 3, 2012

First Submission Date that Met QC Criteria

Sep 3, 2012

First Posted Date

Sep 6, 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

Sep 7, 2012

Last Update Posted Date

Sep 10, 2012Estimated

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

The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

8Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood and cerebrospinal fluid concentration		0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histopathological or cytopathology diagnosis of malignancy
heart, liver and renal function is normal
Expected survival time is more than 3 months
Signed informed consent

exclusion Criteria:

non cancer patient
accepted elemene administration in 1 month
Expected survival time is less than 3 months
no Signed informed consent
heart, liver and renal function is abnormal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

malignant patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ZHAN QIONG, MD	Contact	8621-52887162		zjoan2121@gmail.com

Overall Officials

Name	Affiliation	Role
liang xiaohua, phD	Huashan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huashan Hospital of Fudan University		Shanghai	Shanghai Municipality	200040	China

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided