Unique ID issued by UMIN | UMIN000009414 |
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Receipt number | R000011061 |
Scientific Title | Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib in NSCLC patients |
Date of disclosure of the study information | 2012/12/01 |
Last modified on | 2020/01/04 18:28:36 |
Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib in NSCLC patients
Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib
Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib in NSCLC patients
Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib
Japan |
Non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
YES
To investigate the pharmacokinetic difference of erlotinib between the administration on complete fasting and two hours after meal
Pharmacokinetics
Exploratory
Pragmatic
Not applicable
AUC of erlotinib between the administration on complete fasting and two hours after meal
Interventional
Cross-over
Randomized
Cluster
Open -no one is blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Medicine |
Cohort A:Period 1, administration on two hours after meal; Period 2, on complete fasting.
Cohort B: Period 1, administration on complete fasting ;Period 2, on two hours after meal.
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients with histologically or cytologically diagnosed NSCLC
2)Advanced or metastatic NSCLC
3)Patients aged >20 years
4)PS(ECOG) of 0 to 2
5)Patients planned to undergo erlotinib therapy as clinical practice
6)Patients who have recovered from the toxicities of any pior treatment
7)Having adequate organ function
8)Written informed consent
1)Active primary multiple cancer
2)serious concomitant disorders, including an active infection, active gastrointestinal bleeding, or ileus.
3)History of pulmonary fibrosis or interstitial lung disease
5)Patients who required other chemotherapy, rediotherapy, or immuno therapy
6)Patients who qre actively receiving warfarin, PPI, H2-blocker, or inducer or inhibitor of CYP3A4
7)Current smoker
13)Patients with hepatitis B or C virus or human immunodeficiency virus infection
8)pregnancy or lactation
24
1st name | Tomohide |
Middle name | |
Last name | Tamura |
National Cancer Center Hospital
Division of Internal Medicine and Thoracic Oncology
104-0045
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
0335422511
fu_ji_@yahoo.co.jp
1st name | Yutaka |
Middle name | |
Last name | Fujiwara |
National Cancer Center Hospital
Division of Internal Medicine and Thoracic Oncology
104-0045
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
0335422511
fu_ji_@yahoo.co.jp
Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital
Cancer Fundation
Japanese Governmental office
National Cancer Center Hospital
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
03-3542-2511
yutakafu@ncc.or.jp
NO
2012 | Year | 12 | Month | 01 | Day |
https://link.springer.com/article/10.1007%2Fs00280-015-2778-8
Published
https://link.springer.com/article/10.1007%2Fs00280-015-2778-8
23
AUC and C max in the 2h post-meal status were significantly higher than in the complete fasting status (GMR=1.33, P<0.001; GMR=1.44, P<0.001, respectively). However, because the concentration of erlotinib did not reach the steady state within 7 days in the complete fasting state, we conducted analyses only on day 14, which showed no significant difference in AUC or C max between the two conditions.
2020 | Year | 01 | Month | 04 | Day |
Patients were planned to receive erlotinib therapy as part of their clinical treatment.
Patients were randomly assigned into two cohorts using static block randomization. In cohort A, patients first received erlotinib 2 h after breakfast on days 1 to 7 and then 1 h before breakfast on days 8 to 14. In cohort B, patients received erlotinib 1 h before breakfast on days 1 to 7 and then 2 h after breakfast on days 8 to 14.
In cohort A, a skin rash appeared in 50% of patients within 8 days and in 83% within 15 days. In cohort B, a skin rash was seen in 64% of patients within 8 days and in 82% within 15 days.
PK analysis and toxicity
Completed
2012 | Year | 11 | Month | 22 | Day |
2012 | Year | 11 | Month | 22 | Day |
2012 | Year | 12 | Month | 07 | Day |
2014 | Year | 01 | Month | 31 | Day |
2012 | Year | 11 | Month | 27 | Day |
2020 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011061
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