Unique ID issued by UMIN | UMIN000009867 |
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Receipt number | R000011047 |
Scientific Title | Pharmacokinetic study of crizotinib in Japanese patients with ALK fusion gene positive Non-small cell carcinoma |
Date of disclosure of the study information | 2013/01/31 |
Last modified on | 2020/01/04 18:18:07 |
Pharmacokinetic study of crizotinib in Japanese patients with ALK fusion gene positive Non-small cell carcinoma
Pharmacokinetic study of crizotinib
Pharmacokinetic study of crizotinib in Japanese patients with ALK fusion gene positive Non-small cell carcinoma
Pharmacokinetic study of crizotinib
Japan |
ALK fusion gene positive NSCLC
Hematology and clinical oncology |
Malignancy
YES
To evaluate pharmacokinetics of Crizotinib in Japanese patients with ALK fusion gene positive NSCLC.
PK,PD
Confirmatory
Pragmatic
Not applicable
To evaluate the correlation PK/PD with effects and adverse events of Crizotinib.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Other |
We evaluate pharmacokinetics of Crizotinib.
20 | years-old | <= |
Not applicable |
Male and Female
1.The patient diagnosed as ALK fusion gene positive Non-small cell lung cancer with histological or cytological diagnosis
2.The recurrence and progressive Non-small cell lung cancer which is unresectable
3.The patient who is going to take Crizotinib 250mg twice a day
4.A patiet at least 20 years at the registration within 14 day before registration
5.Laboratory data within 14 days fill following all, total bilirubin : 2.0 or less mg/dl, AST (GOT) : 150 or less IU/L, ALT (GPT) : 150 or less IU/L, serum creatinine : 2.0 or less mg/dL, SpO2 : 90 or more % (room air)
6.The patient has provided signed informed consent
1. The patients need to concurrent treatment with other anticancer therapy, including other chemotherapy, radiotherapy, or immunotherapy.
2. Preexisting interstitial lung disease (ILD)
3. Known positive test results for human immunodeficiency virus (HIV),hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCVb)
4. The digestive disorder which influences absorption of Crizotinib, malabsorption syndrome, gastric resection including stomach subtotal excision, or extensive small intestine resection.
5. Oral feeding difficulty
6. The pregnant patient, patient suspected of being pregnant, or breastfeeding.
7. The patient whom the principal investigator or the doctor in attendance judged not to be suitable as an experimental object
20
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
National Cancer Center Hospital
Self funding
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(東京都)/ National Cancer Center Hospital(Japan)
2013 | Year | 01 | Month | 31 | Day |
https://onlinelibrary.wiley.com/doi/full/10.1111/cas.12983
Published
https://onlinelibrary.wiley.com/doi/full/10.1111/cas.12983
8
In pharmacokinetic analysis, blood samples were obtained on days 1 and 15. The mean area under the plasma concentration-time curve on day 15 was significantly increased in patients with clinically significant AEs compared with those without (P=0.04).
2020 | Year | 01 | Month | 04 | Day |
Inclusion criteria were advanced ALK positive NSCLC scheduled for treatment with crizotinib therapy.
From March 2013 to June 2014, a total of eight patients were enrolled.
All patients experienced at least one AE of any grade of toxicity, and five patients experienced clinically significant AEs. We were able to manage these AEs with supportive care and reduced doses in seven patients.
PK analysis and toxicity
Completed
2013 | Year | 02 | Month | 06 | Day |
2013 | Year | 02 | Month | 06 | Day |
2013 | Year | 02 | Month | 27 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2013 | Year | 01 | Month | 25 | Day |
2020 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011047
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