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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014237
Receipt No. R000016576
Scientific Title A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of afatinib
Date of disclosure of the study information 2014/06/25
Last modified on 2016/12/12

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Basic information
Public title A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of afatinib
Acronym PK analysis of anticancer agent for lung cancer
Scientific Title A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of afatinib
Scientific Title:Acronym PK analysis of anticancer agent for lung cancer
Region
Japan

Condition
Condition adenocarcinoma of the lung
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study assesses the relationship between individual genetic polymorphisms and each result of PK/PD analysis based on maintenance dose, pharmacokinetics, efficacy, and safety in patients with adenocarcinoma of the lung taking afatinib.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To assess PK/PD based on plasma concentration of afatinib, as well as efficacy and safety.
Key secondary outcomes To explore genetic polymorphisms relating to pharmacokinetics, efficacy, and safety of afatinib.

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 with adenocarcinoma of the lung
2. Patients taking afatinib
3. Signed informed consent prior to blood sampling for this study.
Key exclusion criteria No exclusion criteria
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Hayashi
Organization Gifu Pharmaceutical University
Division name Laboratoly of Pharmacy Practice and Social Science
Zip code
Address 1-25-4 Daigakunishi, Gifu
TEL 058-230-8100(3614)
Email hayashih@gifu-pu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Hayashi
Organization Gifu Pharmaceutical University
Division name Laboratoly of Pharmacy Practice and Social Science
Zip code
Address 1-25-4 Daigakunishi, Gifu
TEL 058-230-8100(3614)
Homepage URL
Email hayashih@gifu-pu.ac.jp

Sponsor
Institute Laboratoly of Pharmacy Practice and Social Science, Gifu Pharmaceutical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Gifu University Hospital
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 岐阜大学医学部附属病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 25 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
2014 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observational study

Management information
Registered date
2014 Year 06 Month 11 Day
Last modified on
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016576

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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