Unique ID issued by UMIN | UMIN000017750 |
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Receipt number | R000020561 |
Scientific Title | Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib in EGFR mutation-positive non-small cell lung cancer |
Date of disclosure of the study information | 2015/06/01 |
Last modified on | 2017/07/31 22:06:13 |
Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib
in EGFR mutation-positive non-small cell lung cancer
Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib
in EGFR mutation-positive non-small cell lung cancer
Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib
in EGFR mutation-positive non-small cell lung cancer
Phase II study to prove the validity of Hange-shashin-to for diarrhea by Afatinib
in EGFR mutation-positive non-small cell lung cancer
Japan |
EGFR mutation-positive non-small cell lung cancer
Pneumology | Hematology and clinical oncology | Adult |
Malignancy
NO
to prove the validity of Hange-shashin-to for diarrhea by Afatinib
Efficacy
Onset of Grade 2 more diarrhea within 28 days by Afatinib
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Hange-shashin-to
20 | years-old | <= |
Not applicable |
Male and Female
(1)Histologically confirmed non-squamous cell lung cancer
(2)Stage IV or recurrent NSCLC
(3)Harboring sensitive EGFR mutation
(4)Patients who are scheduled for administration of Afatinib
(5)20 years or older
(6)Performance Status (ECOG) 0-2
(7)Having adequate organ functions
(8) Estimated life expectancy at least 3 months
(9)With written informed consent
(1)Having problematic interstitial lung disease or lung fibrosis on chest CT
(2)Having severe organ dysfunction
(3)Having sever malabsorption syndrome or gastrointestinal dysfunction as follows, after total gastrectomy, active peptic ulcer, active inflammatory bowel disease
(4)Pregnant women, or having possibility of pregnancy; man having no intent to birth control
(5)In addition to the above, any contraindications to Afatinib or Hange-shashin-to
(6)Having active gastrointestinal tumor
(7)In addition, the primary doctor judging inappropriate for entry
15
1st name | |
Middle name | |
Last name | Ou Yamaguchi |
Saitama Medical University International Medical Center
respiratory medicine
Hidaka city, Saitama
042-984-4111
ouyamaguchi@gmail.com
1st name | |
Middle name | |
Last name | Ou Yamaguchi |
Saitama Medical University International Medical Center
respiratory medicine
respiratory medicine
042-984-4111
ouyamaguchi@gmail.com
Saitama Medical University International Medical Center
Saitama Medical University International Medical Center
Self funding
NO
2015 | Year | 06 | Month | 01 | Day |
Unpublished
Completed
2015 | Year | 04 | Month | 20 | Day |
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 05 | Month | 31 | Day |
2017 | Year | 07 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020561
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