Unique ID issued by UMIN | UMIN000021160 |
---|---|
Receipt number | R000024403 |
Scientific Title | A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation combined with venous thromboembolism |
Date of disclosure of the study information | 2016/03/01 |
Last modified on | 2019/09/28 12:55:21 |
A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation combined with venous thromboembolism
A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation
A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation combined with venous thromboembolism
A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To investigate pharmacokinetic parameters of edoxaban in non-small cell lung cancer patients harboring EGFR mutation combined with venous thromboembolism
Pharmacokinetics
Exploratory
Explanatory
Not applicable
Pharmacokinetic analysis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Prevention
Maneuver |
blood sampling
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
20
1st name | |
Middle name | |
Last name | Takeshi Isobe |
Shimane University Faculty of Medicine
Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
89-1 Enya-cho, Izumo, Shimane
0853-20-2580
isobeti@med.shimane-u.ac.jp
1st name | |
Middle name | |
Last name | Yukari Tsubata |
Shimane University Faculty of Medicine
Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
89-1 Enya-cho, Izumo, Shimane
0853-20-2580
ytsubata@med.shimane-u.ac.jp
Shimane University Faculty of Medicine
Daiichi Sankyo
Profit organization
NO
2016 | Year | 03 | Month | 01 | Day |
Unpublished
Main results already published
2016 | Year | 01 | Month | 18 | Day |
2016 | Year | 01 | Month | 13 | Day |
2016 | Year | 06 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 02 | Month | 23 | Day |
2019 | Year | 09 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024403
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |