Unique ID issued by UMIN | UMIN000022252 |
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Receipt number | R000025635 |
Scientific Title | Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM) |
Date of disclosure of the study information | 2016/05/10 |
Last modified on | 2016/08/17 16:35:17 |
Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM)
Phase II study of low-dose afatinib for elderly NSCLC patients
Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM)
Phase II study of low-dose afatinib for elderly NSCLC patients
Japan |
Non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate the efficacy and safety of low dose afatinib (20mg/day) for elderly patients with non-small cell lung cancer harboring EGFR mutation
Safety,Efficacy
Exploratory
Phase II
Progression-free survival
Response rate, Overall survival, Incidence of adverse events, PK analysis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
1) Treatment with afatinib at a dose of 20 mg daily (until PD).
2) At day 7-14 after the start of afatinib, samples for pharmacokinetc analyses will be obtained (9 points).
3) Afatinib were permitted to dose escalate, if patients did not experience Gr 1 diarrhea and Gr 1 anorexia with trough concentration of afatinib < 15 ng/mL at day 7-14.
75 | years-old | <= |
Not applicable |
Male and Female
1) Pathologically confirmation of non small cell lung cancer
2) Clinical stage IIIB, IV, or postoperative recurrence
3) With activating EGFR mutation (Deletion in exon 19 or L858R in exon 21)
4) ECOG performance status 0-2
5) No prior therapy of EGFR-TKI
6) Measurable lesions based on RECIST ver1.1
7) Adequate organ functions
8) Written informed consent
1) Interstitial lung disease
2) Receiving continuous systemic corticosteroid
3) During pregnancy or lactation
4) Psychological disorder difficult to participate in this clinical study
25
1st name | |
Middle name | |
Last name | Toshiaki Takahashi |
Shizuoka Cancer Center
Division of Thoracic Oncology
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
055-989-5222
t.takahashi@scchr.jp
1st name | |
Middle name | |
Last name | Hirotsugu Kenmotsu |
Shizuoka Cancer Center
Division of Thoracic Oncology
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
055-989-5222
h.kenmotsu@scchr.jp
Shizuoka Cancer Center
Grants-in-Aid for Scientific Research
Japanese Governmental office
Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine
NO
静岡県立静岡がんセンター(静岡県)
2016 | Year | 05 | Month | 10 | Day |
Unpublished
Open public recruiting
2016 | Year | 03 | Month | 30 | Day |
2016 | Year | 08 | Month | 04 | Day |
2016 | Year | 05 | Month | 09 | Day |
2016 | Year | 08 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025635
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