UMIN-CTR Clinical Trial

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

Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013388
Receipt No. R000013307
Scientific Title Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Date of disclosure of the study information 2014/03/12
Last modified on 2014/03/11

* 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 Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Acronym Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Scientific Title Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Scientific Title:Acronym Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study evaluates the plasma dispositions of erlotinib and OSI-420, a major metabolite of erlotinib, and the clinical response to erlotinib based on the genetic variants of drug metabolizing enzymes and transporters in non-small cell lung cancer patients receiving oral erlotinib.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Trough plasma concentrations of erlotinib and OSI-420 before dosing on day 8 or later
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patients receiving oral erlotinib to non-small cell lung cancer
2. Patients receiving written informed consent
Key exclusion criteria 1. Patients discontinued receiving treatment of oral erlotinib
2. Patients having severe kidney dysfunction or liver dysfunction
3. Patients who are judged by physicians as inappropriate for study enrollment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Kawakami
Organization Hamamatsu University School of Medicine
Division name Department of Hospital Pharmacy
Zip code
Address 1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
TEL 053-435-2623
Email pharmacyham-adm@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Naito
Organization Hamamatsu University School of Medicine
Division name Department of Hospital Pharmacy
Zip code
Address 1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
TEL 053-435-2623
Homepage URL
Email pharmacyham-adm@umin.ac.jp

Sponsor
Institute Department of Hospital Pharmacy
Hamamatsu University School of Medicime
Institute
Department

Funding Source
Organization Department of Hospital Pharmacy
Hamamatsu University School of Medicime
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

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 12 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 Enrolling by invitation
Date of protocol fixation
2010 Year 11 Month 19 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 To evaluate the plasma dispositions of and the clinical response to
erlotinib and its active metabolites based on the cachexia stage and genetic variants of drug metabolizing enzymes and drug transporters and drug receptors

Management information
Registered date
2014 Year 03 Month 11 Day
Last modified on
2014 Year 03 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013307

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.