Unique ID issued by UMIN | UMIN000013388 |
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Receipt number | R000013307 |
Scientific Title | Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib. |
Date of disclosure of the study information | 2014/03/12 |
Last modified on | 2014/03/11 09:34:40 |
Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Investigation of interindividual factors in erlotinib and its metabolites pharmacokinetics, clinical responses and adverse reactions in Japanese non-small cell lung cancer patients receiving oral erlotinib.
Japan |
non-small cell lung cancer
Pneumology | Chest surgery |
Malignancy
YES
This study evaluates the plasma dispositions of erlotinib and OSI-420, a major metabolite of erlotinib, and the clinical response to erlotinib based on the genetic variants of drug metabolizing enzymes and transporters in non-small cell lung cancer patients receiving oral erlotinib.
PK,PD
Trough plasma concentrations of erlotinib and OSI-420 before dosing on day 8 or later
Observational
Not applicable |
Not applicable |
Male and Female
1. Patients receiving oral erlotinib to non-small cell lung cancer
2. Patients receiving written informed consent
1. Patients discontinued receiving treatment of oral erlotinib
2. Patients having severe kidney dysfunction or liver dysfunction
3. Patients who are judged by physicians as inappropriate for study enrollment
50
1st name | |
Middle name | |
Last name | Junichi Kawakami |
Hamamatsu University School of Medicine
Department of Hospital Pharmacy
1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
053-435-2623
pharmacyham-adm@umin.ac.jp
1st name | |
Middle name | |
Last name | Takafumi Naito |
Hamamatsu University School of Medicine
Department of Hospital Pharmacy
1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
053-435-2623
pharmacyham-adm@umin.ac.jp
Department of Hospital Pharmacy
Hamamatsu University School of Medicime
Department of Hospital Pharmacy
Hamamatsu University School of Medicime
Self funding
NO
2014 | Year | 03 | Month | 12 | Day |
Unpublished
Enrolling by invitation
2010 | Year | 11 | Month | 19 | Day |
2011 | Year | 01 | Month | 01 | Day |
To evaluate the plasma dispositions of and the clinical response to
erlotinib and its active metabolites based on the cachexia stage and genetic variants of drug metabolizing enzymes and drug transporters and drug receptors
2014 | Year | 03 | Month | 11 | Day |
2014 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013307
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