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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028922
Receipt No. R000032958
Scientific Title Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Date of disclosure of the study information 2017/09/15
Last modified on 2017/08/23

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Basic information
Public title Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Acronym Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Scientific Title Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Scientific Title:Acronym Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the relation between malignant effusion and concentration of osimertinib in patients with non-small cell lung cancer
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association of malignant effusion with osimertinib exposure in non-small cell lung cancer
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathologically confirmation of non small cell lung cancer
2) The history of EGFR-TKI therapies
3) Detected T790M mutation by rebiopsy samples
4) Administration of osimertinib is planned or ongoing
5) At least one or more measurable lesion by RESIST (Version1.1) (patients who have only pleural effusion are eligible)
6) Aged 20 or more
7) Written informed consent
Key exclusion criteria Patients with interstitial pneumonitis identified by chest X-ray
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Takahashi
Organization Shizuoka cancer center
Division name Devision of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL (+81)055-989-5222
Email t.takahashi@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Kawamura/ Kenmotsu Hirotsugu
Organization Shizuoka cancer center
Division name Devision of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL (+81)055-989-5222
Homepage URL
Email ta.kawamura@scchr.jp

Sponsor
Institute Shizuoka cancer center
Institute
Department

Funding Source
Organization Shizuoka cancer center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor 1) Pharmaceutics, school of medicine, Keio University
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
2017 Year 09 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is conducted to evaluate the relation between malignant effusion and concentration of osimertinib in patients with non-small cell lung cancer

Management information
Registered date
2017 Year 08 Month 31 Day
Last modified on
2017 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032958

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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