UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004703
Receipt No. R000005600
Scientific Title Plasma and cerebrospinal fluid concentrations treated with daily dose and high dose weekly erlotinib in non-small cell lung cancer patients with central nervous system metastases
Date of disclosure of the study information 2010/12/10
Last modified on 2017/05/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Plasma and cerebrospinal fluid concentrations treated with daily dose and high dose weekly erlotinib in non-small cell lung cancer patients with central nervous system metastases
Acronym CSF concentrations treated with high dose weekly erlotinib in patients with CNS metastases
Scientific Title Plasma and cerebrospinal fluid concentrations treated with daily dose and high dose weekly erlotinib in non-small cell lung cancer patients with central nervous system metastases
Scientific Title:Acronym CSF concentrations treated with high dose weekly erlotinib in patients with CNS metastases
Region
Japan

Condition
Condition central nervous system metastases of non-small cell lung cancer with active EGFR mutations treated with daily dosing erlotinib
Classification by specialty
Pneumology Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 PK/PD analyses of plasma and CSF in patients treated with daily dosing and high dose weekly erlotinib
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes relation of clinical efficacy and CSF penetration rate of erlotinib
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 erlotinib: 150mg daily
Failure with CNS metastases: 1500 mg weekly

erlotinib: 150mg daily
PK/PD analyses in day8 and in day15

erlotinib: 1500mg weekly
PK/PD analyses in day8
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.non-small cell lung cancer
2.nervous system metastases
3.active EGFR mutations
4.obtained informed consents
Key exclusion criteria 1.IIPs
2.drug hypersensitivity reaction
with gefitinib or erlotinib
3.high risk of brain herniation by lumbar puncture
4.unsuitable for treatment
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinzoh Kudoh
Organization Osaka City University
Division name Department of Respiratory medicine
Zip code
Address 1-4-3 Asahimachi Abenoku Osaka Japan
TEL 06-6645-3916
Email kimutats@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Kimura
Organization Osaka City University
Division name Department of Respiratory medicine
Zip code
Address 1-1-43, Abenosuji, abeno-ku, Osaka 545-6090 JAPAN
TEL 06-6645-3916
Homepage URL
Email kimutats@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization Osaka City University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪市立大学

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 12 Month 10 Day
Last modified on
2017 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.