Unique ID issued by UMIN | UMIN000017050 |
---|---|
Receipt number | R000019762 |
Scientific Title | First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib- |
Date of disclosure of the study information | 2015/04/10 |
Last modified on | 2019/04/08 13:23:42 |
First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib-
First-Line Afatinib in Patients Aged 75 or Older
First-Line Afatinib in Patients Aged 75 or Older With Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation -Multicenter study on the Pharmacokinetics and pharmacogenetics of Afatinib-
First-Line Afatinib in Patients Aged 75 or Older
Japan |
patients aged 75 or older
with advanced non small cell lung cancer harboring EGFR mutation
Pneumology |
Malignancy
YES
To evaluate the efficacy and safty of afatinib in patients aged 75 or older
with advanced non small cell lung cancer harboring EGFR mutation
PK,PD
Phase II
response rate
disease control rate
progression free survival
overall survival
Adverse events
Quality of life
PK/PGx
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
afatinib
75 | years-old | <= |
Not applicable |
Male and Female
1)Histlogically or cytologically confirmed EGFR mutation positive non small cell lung cancer(NSCLC)
2)Unresectable and metastatic NSCLC
3)Harboring sensitive EGFR mutation
4)Patients who have never treated with EGFR-TKI and cytotoxic chemotherapy.
5)More than 75 years old
6)Performance Status (ECOG) 0-1
7)Measurable lesion for RECIST(version 1.1)
8)Adequate organ functions
9)Life expectancy over 3 months
10)Written informed consent
1)Concomitant treatment with other anticancer agent, radiotherapy, or immunotherapy.
2)Preexisting interstitial lung disease of chest CT
3)HBs antigen positive
4)HBs or HBc antibody positive, and HBV-DNA positive
5)EGFR minor mutation or exon 20 T790M
6)Active double cancer
7)Digestive disease influencing absorption of afatinib
8)Oral feeding difficulty
9)Patients whose attending doctor consider as inappropriate for this study
35
1st name | |
Middle name | |
Last name | Oizumi Satoshi |
Hokkaido Cancer Center
Respiratory Medicine
Kikusui4, West 2, Shiroishi-ku, Sapporo
011-811-9111
soizumi@sap-cc.go.jp
1st name | |
Middle name | |
Last name | Hidenori Mizugaki |
Hokkaido University Hospital
First department of medicine
North 14, West 5, Kita-ku, Sapporo
011-706-5911
mhide@med.hokudai.ac.jp
Hokkaido University Hospital, First department of medicine
Cancer Fundation
Japanese Governmental office
National Cancer Center
NO
2015 | Year | 04 | Month | 10 | Day |
Unpublished
Completed
2015 | Year | 03 | Month | 04 | Day |
2015 | Year | 07 | Month | 14 | Day |
2015 | Year | 07 | Month | 15 | Day |
2019 | Year | 02 | Month | 28 | Day |
2019 | Year | 07 | Month | 31 | Day |
2015 | Year | 04 | Month | 05 | Day |
2019 | Year | 04 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019762
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |