Unique ID issued by UMIN | UMIN000044627 |
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Receipt number | R000050975 |
Scientific Title | Association of osimertinib induced dry skin with stratum corneum lipids change and blood level |
Date of disclosure of the study information | 2021/06/23 |
Last modified on | 2021/06/23 10:12:15 |
Association of osimertinib induced dry skin with stratum corneum lipids change and blood level
Association of osimertinib induced dry skin with stratum corneum lipids change and blood level
Association of osimertinib induced dry skin with stratum corneum lipids change and blood level
Association of osimertinib induced dry skin with stratum corneum lipids change and blood level
Japan |
Non-small cell lung cancer
Pneumology | Dermatology | Adult |
Malignancy
YES
To investigate the association of dry skin induced by osimertinib with stratum corneum lipid change and blood levels
Safety,Efficacy
Transepidermal water loss(TEWL), Analysis of
stratum corneum components and structure, blood concentration of osimertinib
Observational
20 | years-old | <= |
100 | years-old | >= |
Male and Female
1. Patients who are histologically diagnosed with non-small cell clung cancer
2. Patinents who are recurrent or progressive non-small-cell lung cancer
3. More than 20-years olds patients at the time of enrollement
4. ECOG Performance status of 0-2
5. Patients who are possible oral ingestion
6. Patients who are expected to survive more than 3 months from the time of enrollment
7. Patients who provide written informed consent for entry of this trial
1. Patients with a history of allergy for a component of osimertinib
2. Patients with a history of serious drug allergy
3. Patients with other serious complications
4. Patients who are in pregnancy or intend to get pregnant
5. Patients with orally steroid treatment
6. Patients who are considered to be inappropriate in enrollment of this trial by attending physicians
40
1st name | Tomonobu |
Middle name | |
Last name | Uchino |
Univercity of Shizuoka
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences
422-8526
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
+81-54-264-5771
uchinot@u-shizuoka-ken.ac.jp
1st name | Tomonobu |
Middle name | |
Last name | Uchino |
University of Shizuoka
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences
422-8526
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
+81-54-264-5771
uchinot@u-shizuoka-ken.ac.jp
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences, University of Shizuoka
University of Shizuoka
Other
Shizuoka general hospital
4-27-1 kitaando aoi-ku shizuoka-shi Shizuoka, Japan
054-247-6111
chiken-sougou@shizuoka-pho.jp
YES
SGHIRB#2020084
Shizuoka general hospital
静岡県立総合病院 臨床研究倫理委員会
2021 | Year | 06 | Month | 23 | Day |
Unpublished
Enrolling by invitation
2021 | Year | 01 | Month | 25 | Day |
2021 | Year | 01 | Month | 25 | Day |
2021 | Year | 06 | Month | 23 | Day |
2024 | Year | 09 | Month | 30 | Day |
On the day of taking osimertinib (Day 0), on days 7, 14, 28, and 56 from the start of administration, the blood are collected. On same days, the stratum corneum is collected from inner forearm with tape stripping method after measurement of transepidermal water loss.
From the obtained sample, blood osimertinib concentration, CYP3A gene polymorphism, stratum corneum intercellular lipid component and structure are analyzed.
Association of the data obtained and clinical symptoms will be investigated.
2021 | Year | 06 | Month | 23 | Day |
2021 | Year | 06 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050975
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