CancerNCT01679847
Blood Brain Barrier Penetration and Pharmacokinetics of the Elemene in Malignant Patients.
An observational study of Cancer, run by Dalian Holley Kingkong Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: malignant patients
Who may be able to join
- histopathological or cytopathology diagnosis of malignancy
- heart, liver and renal function is normal
- Expected survival time is more than 3 months
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.
- Conditions
- Cancer
- Keywords
- Elemene, pharmacokinetics, Blood-brain barrier
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
blood and cerebrospinal fluid concentration
Measured: 0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalian Holley Kingkong Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- liang xiaohua, phD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679847
- Sponsor's protocol ID
- HSZL201001
- Status last verified
- Sep 2012
- First submitted
- 3 Sep 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Brain Barrier Penetration and Pharmacokinetics of the Elemene in Malignant Patients.
- ClinicalTrials.gov ID
- NCT01679847
- Acronym / sponsor ID
- HSZL201001
- Conditions
- Cancer
- Keywords
- Elemene, pharmacokinetics, Blood-brain barrier
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Dalian Holley Kingkong Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to elucidate the pharmacokinetics and the blood-brain barrier penetration of the elemene.
Study design
- Observational model
- Case only
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- malignant patients
Key inclusion criteria (4 listed)
- histopathological or cytopathology diagnosis of malignancy
- heart, liver and renal function is normal
- Expected survival time is more than 3 months
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood and cerebrospinal fluid concentration
Time frame: 0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
liang xiaohua, phD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Dalian Holley Kingkong Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZHAN QIONG, MD (8621-52887162, zjoan2121@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood and cerebrospinal fluid concentration (time frame: 0，0.25，0.5，1，1.5，2，3，3.5，4，6，8，12 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.