Unique ID issued by UMIN | UMIN000012862 |
---|---|
Receipt number | R000015023 |
Scientific Title | Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer |
Date of disclosure of the study information | 2014/01/16 |
Last modified on | 2016/05/09 19:06:08 |
Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Efficacy and pharmacokinetics study of erlotinib in patients with non-small cell lung cancer
Japan |
Advanced non-small cell lung cancer
Pneumology |
Malignancy
YES
To determine the correlation between erlotinib pharmacokinetics and clinical response in non-small cell lung cancer
PK,PD
Exploratory
Not applicable
Correlation between erlotinib exposure and clinical response
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Pathologically confirmation of non small cell lung cancer
2) No prior therapy of EGFR-TKI
3) Administration of erlotinib is planned
4) EGFR gene mutation has been examined
5) Measurable lesions based on RECIST ver1.1
6) Aged 20 or more
7) Expected survival over 12 weeks
8) Adequate organ functions
9) Written informed consent
Patients with interstitial pneumonitis identified by chest X-ray
70
1st name | |
Middle name | |
Last name | Toshiaki Takahashi |
Shizuoka cancer center
Devision of Thoracic Oncology
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
(+81)055-989-5222
t.takahashi@scchr.jp
1st name | |
Middle name | |
Last name | Kenmotsu Hirotsugu |
Shizuoka cancer center
Division of Thoracic Oncology
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
(+81)055-989-5222
h.kenmotsu@scchr.jp
Shizuoka cancer center
Shizuoka cancer center
Other
1) Pharmaceutics, school of medicine, Keio University
2) RIKEN Center for Genomic Medicine
NO
2014 | Year | 01 | Month | 16 | Day |
Unpublished
No longer recruiting
2013 | Year | 10 | Month | 15 | Day |
2014 | Year | 03 | Month | 19 | Day |
Blood samples are collected before and 0,2,4,6,12 and 24 hour after Erlotinib Administration. Samples are collected before taking erlotinib.
2014 | Year | 01 | Month | 15 | Day |
2016 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015023
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |