NCT01679847

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

7 months

First QC Date

September 3, 2012

Last Update Submit

September 7, 2012

Conditions

Cancer

Keywords

ElemenepharmacokineticsBlood-brain barrier

Outcome Measures

Primary Outcomes (1)

  • blood and cerebrospinal fluid concentration

    0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

malignant patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and Cerebrospinal fluid

MeSH Terms

Conditions

Neoplasms

Study Officials

  • liang xiaohua, phD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHAN QIONG, MD

CONTACT

8621-52887162zjoan2121@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 6, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

CN(1)