UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004703 |
|---|---|
| Receipt number | 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 16:30:02 |
* 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
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
kimutats@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005600
