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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043773
Receipt No. R000049968
Scientific Title Plasma concentration monitoring of osimertinib and its active metabolites to assess clinical efficacy of osimertinib
Date of disclosure of the study information 2021/03/29
Last modified on 2021/03/29

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Basic information
Public title Plasma concentration monitoring of osimertinib and its active metabolites
to assess clinical efficacy of osimertinib
Acronym Plasma concentration monitoring of osimertinib and its active metabolites
to assess clinical efficacy of osimertinib
Scientific Title Plasma concentration monitoring of osimertinib and its active metabolites
to assess clinical efficacy of osimertinib
Scientific Title:Acronym Plasma concentration monitoring of osimertinib and its active metabolites
to assess clinical efficacy of osimertinib
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Plasma concentration monitoring of osimertinib and its active metabolites
to assess clinical efficacy of osimertinib
Basic objectives2 Others
Basic objectives -Others Patient background
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To verify the efficacy of osimertinib, plasma concentration of osimertinib and its active metabolites (AZ5104, AZ7550) will be measured.
Key secondary outcomes Patient background

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Taking osimertinib for EGFR mutation-positive inoperable or recurrent non-small cell lung cancer.
Key exclusion criteria Clinical difficulties in this trial
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takae
Middle name
Last name Okuno
Organization Shimane University Hospital
Division name Medical Oncology and Respiratory Medicine
Zip code 693-8501
Address 89-1 Enya-cho Izumo-shi shimane, Japan
TEL 0853-20-2580
Email takae007@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Takae
Middle name
Last name Okuno
Organization Shimane University Hospital
Division name Medical Oncology and Respiratory Medicine
Zip code 693-8501
Address 89-1 Enya-cho Izumo-shi shimane, Japan
TEL 0853-20-2580
Homepage URL
Email takae007@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
Medical Oncology and Respiratory Medicine
Institute
Department

Funding Source
Organization Shimane University Hospital
Medical Oncology and Respiratory Medicine
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 Shimane University Hospital
Address Medical Oncology and Respiratory Medicine
Tel 0853-20-2580
Email takae007@med.shimane-u.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 島根大学医学部附属病院(島根県)

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 29 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 20 Day
Date of IRB
2018 Year 12 Month 20 Day
Anticipated trial start date
2017 Year 12 Month 20 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2021 Year 03 Month 29 Day
Last modified on
2021 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049968

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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