UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014237 |
|---|---|
| Receipt number | 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 | 2023/06/18 12:51:35 |
* 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
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 | Hideki |
| Middle name | |
| Last name | Hayashi |
Organization
Gifu Pharmaceutical University
Division name
Laboratoly of Pharmacy Practice and Social Science
Zip code
501-1196
Address
1-25-4 Daigakunishi, Gifu
TEL
058-230-8100(3614)
hayashih@gifu-pu.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Hayashi |
Organization
Gifu Pharmaceutical University
Division name
Laboratoly of Pharmacy Practice and Social Science
Zip code
501-1196
Address
1-25-4 Daigakunishi, Gifu
TEL
058-230-8100(3614)
Homepage URL
hayashih@gifu-pu.ac.jp
Sponsor or person
Institute
Laboratoly of Pharmacy Practice and Social Science, Gifu Pharmaceutical University
Institute
Department
Personal name
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
Research Ethics Committee, Gifu Pharmaceutical University
Address
1-25-4 Daigakunishi, Gifu
Tel
058-230-8100
hayashih@gifu-pu.ac.jp
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
43
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
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
| 2023 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016576
