Unique ID issued by UMIN | UMIN000009846 |
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Receipt number | R000010758 |
Scientific Title | Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib in patients with ALK fusion gene positive NSCLC |
Date of disclosure of the study information | 2013/01/31 |
Last modified on | 2020/01/04 18:08:32 |
Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib in patients with ALK fusion gene positive NSCLC
Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib
Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib in patients with ALK fusion gene positive NSCLC
Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib
Japan |
ALK fusion gene positive NSCLC
Hematology and clinical oncology |
Malignancy
YES
To analyse pharmacokinetics and pharmacogenetics of Crizotinib in Japanese patients with ALK fusion gene positive NSCLC
PK,PD
Exploratory
Explanatory
Not applicable
To evaluate the correlation polymorphisms of ABCB1 and CYP3A4/5 with steady state plasma concentration and adverse events of Crizotinib.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Other |
To evaluate steady state plasma concentration of Crizotinib and its metabolites.
To analyse gene polymorphism.
To evaluate plasma concentration of Crizotinib and its metabolites at the time of occurence of severe adverse events.
20 | years-old | <= |
Not applicable |
Male and Female
1.Histlogically or cytologically confirmed ALK fusion gene positive NSCLC
2.Unresectable and metastatic NSCLC
3.The patient who is plan to receive Crizotinib therapy (250mg twice a day)
1. Concomitant treatment with other anticancer agent, radiotherapy, or immunotherapy.
2. Preexisting interstitial lung disease
100
1st name | Tomohide |
Middle name | |
Last name | Tamura |
National Cancer Center Hospital
Thoracic Oncology
104-0045
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
03-3542-2511
ttamura@ncc.go.jp
1st name | Yutaka |
Middle name | |
Last name | Fujiwara |
National Cancer Center Hospital
Thoracic Oncology
104-0045
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
03-3542-2511
yutakafu@ncc.go.jp
National Cancer Center Hospital
Cancer Fundation
Japanese Governmental office
JAPAN
National Cancer Center Hospital
Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN
03-3542-2511
yutakafu@ncc.go.jp
NO
国立がん研究センター中央病院(東京)、国立がん研究センター東病院(千葉)、がん研究会有明病院(東京)、北海道医学部(北海道)、都立駒込病院(東京)、北里大学医学部(神奈川)、神奈川県循環器呼吸器病センター(神奈川)、名古屋大学医学部(愛知)、名古屋医療センター(愛知)、大阪市立総合医療センター(大阪)、兵庫県立がんセンター(兵庫)、島根大学医学部(島根)、久留米大学医学部(福岡)、熊本大学医学部(熊本)
2013 | Year | 01 | Month | 31 | Day |
https://www.lungcancerjournal.info/article/S0169-5002(18)30683-4/fulltext
Published
https://www.lungcancerjournal.info/article/S0169-5002(18)30683-4/fulltext
75
We identified clinically significant AEs in 35% of 75 NSCLC patients.
We evaluated AEs and germline variations by target-gene panel sequencing.
These AEs were associated with nonsynonymous SNVs in EPHX1 and TCF7L2.
Germline multi-gene information might be useful for predicting AEs.
2020 | Year | 01 | Month | 04 | Day |
Key inclusion criteria were as follows: advanced NSCLC patients harboring the ALK-fusion gene, those planned to receive 250mg of crizotinib twice daily or who were currently under crizotinib treatment,
A total of 78 patients were enrolled between March 2013 and October 2014.
Common events included elevated AST/ALT levels (37.5%), neutropenia (16.7%), ILD (12.5%), and thromboembolic events (12.5%), including pulmonary embolism (n=2) and deep vein thrombosis (n=1). There was one treatment-related death as a result of ILD.
PK analysis and PGx analysis
Completed
2013 | Year | 01 | Month | 22 | Day |
2013 | Year | 01 | Month | 22 | Day |
2013 | Year | 02 | Month | 01 | Day |
2014 | Year | 10 | Month | 31 | Day |
2013 | Year | 01 | Month | 23 | Day |
2020 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010758
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