UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000591
Receipt No. R000000719
Scientific Title Study of pharmacokinetics and the best way of administration of gefitinib for treated lung adenocarcinoma
Date of disclosure of the study information 2007/02/15
Last modified on 2007/02/02

* 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 Study of pharmacokinetics and the best way of administration of gefitinib for treated lung adenocarcinoma
Acronym Study of pharmacokinetics and the best way of administration of gefitinib for treated lung adenocarcinoma
Scientific Title Study of pharmacokinetics and the best way of administration of gefitinib for treated lung adenocarcinoma
Scientific Title:Acronym Study of pharmacokinetics and the best way of administration of gefitinib for treated lung adenocarcinoma
Region
Japan

Condition
Condition Lung adenocarcinoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study of pharmacokinetics and the best way of administration of gefitinib for treated lung adenocarcinoma
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tolerance
Key secondary outcomes Pharmacokinetics of gefitinib
Response rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 250mg of gefitinib, every other day.
Interventions/Control_2 250mg of gefitinib everyday, every other week.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Lung adenocarcinoma
Treated case
Performance status is less than 4
No interstitial pneumonitis
Informed consent is given
Enough function of major organs
Key exclusion criteria severe complication
pregnant
diarrhea
current smoker
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Hirano
Organization International madical center of Japan
Division name Respiratory medicine
Zip code
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization International madical center of Japan
Division name Respiratory medicine
Zip code
Address
TEL
Homepage URL
Email shirano@imcj.hosp.go.jp

Sponsor
Institute International madical center of Japan
Institute
Department

Funding Source
Organization Japan Foundation for the Promotion of International Medical Research Cooperation
Organization
Division
Category of Funding Organization Non profit foundation
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

Other administrative information
Date of disclosure of the study information
2007 Year 02 Month 15 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
Date of protocol fixation
2006 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 02 Month 02 Day
Last modified on
2007 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.