UMIN-CTR Clinical Trial

Basic information
Public title	A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation combined with venous thromboembolism
Acronym	A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation
Scientific Title	A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation combined with venous thromboembolism
Scientific Title:Acronym	A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate pharmacokinetic parameters of edoxaban in non-small cell lung cancer patients harboring EGFR mutation combined with venous thromboembolism
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Pharmacokinetic analysis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	blood sampling
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	Pathologically or cytologically diagnosed non-small-cell lung cancer harboring EGFR mutation ECOG PS 0-2 Age over 20 years old. Non-small-cell lung cancer of stage IIIB or IV Reccurence of operation or concurrent chemoradiotherapy 2 months or longer expected survival. Written informed consent.
Key exclusion criteria	History of allergic reaction for edoxavan Severe renal dysfunction (Ccr under 30 mL/min) Severe liver disease Interstitial pneumonia Plannning for concurrent chemoradiotherapy Started medication or treatment for VTE Active bleeding Severe hypertention A pregnant woman, a woman in breast-feeding Taking aspirin or two kind os antiplatelet drug Acute infectious endocarditis An inappropriate case judged by doctor in charge
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Isobe
Organization	Shimane University Faculty of Medicine
Division name	Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
Address	89-1 Enya-cho, Izumo, Shimane
TEL	0853-20-2580
Email	isobeti@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yukari Tsubata
Organization	Shimane University Faculty of Medicine
Division name	Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
Address	89-1 Enya-cho, Izumo, Shimane
TEL	0853-20-2580
Homepage URL
Email	ytsubata@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization	Daiichi Sankyo
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 03 Month 01 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	Main results already published
Date of protocol fixation	2016 Year 01 Month 18 Day
Date of IRB	2016 Year 01 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 02 Month 23 Day
Last modified on	2019 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024403