Unique ID issued by UMIN | UMIN000015552 |
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Receipt number | R000018071 |
Scientific Title | The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation |
Date of disclosure of the study information | 2014/10/28 |
Last modified on | 2014/10/28 19:57:08 |
The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation
The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation
The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation
The feasibility study and biomarker research of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To investigate the efficacy and safety of afatinib in patients with previously treated advanced NSCLC harboring EGFR mutation, and to analyze the biomarker of afatinib
Safety,Efficacy
Phase II
Response rate (RR)
Disease control rate (DCR), Progression free survival (PFS), Overall survival (OS), Safety and Biomarker research of afatinib
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Afatinib 40mg/day
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically and/or cytologically proven NSCLC
2) Unresectable clinical stage IIIB/IV
3) Patients who have sensitive EGFR mutation (exon19 deletion, exon21 L858R)
4) Previous treated with platinum combination chemotherapy and EGFR-TKI (gefitinib or erlotinib), or the platinum combination chemotherapy is unacceptable
5) Measurable or evaluable disease for RECIST
6) Age: over 20
7) PS (ECOG): 0-2
8) Adequate organ functions judged by laboratory tests
9) Life expectancy: over 3 months
10) Written informed consent
1) Patient with serious disease condition (interstitial pneumonia, lung fibrosis, pneumoconiosis, drug-induced pneumonia, radiation pneumonitis)
2) Patient with much ascetic fluid, pleural effusion, cardiac effusion.
3) Patient with active infection
4) Pregnancy
5) Symptomatic brain metastases
6) Patient with active double cancer
7) Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities.
8) Considered to be interfere to the agreement or understanding the protocol by attending doctor.
45
1st name | |
Middle name | |
Last name | Yoshiki Ishii |
Dokkyo Medical University
Department of Pulmonary Medicine and Clinical Immunology
880 Kitakobayashi, Mibu, Tochigi, Japan
0282-87-2151
ishiiysk@dokkyomed.ac.jp
1st name | |
Middle name | |
Last name | Ryo Arai |
Dokkyo Medical University
Department of Pulmonary Medicine and Clinical Immunology
880 Kitakobayashi, Mibu, Tochigi, Japan
0282-87-2151
r-arai@dokkyomed.ac.jp
Dokkyo Medical University
Dokkyo Medical University
Self funding
Tochigi-kitakan Thoracic Oncology Research Organization (TOTORO)
NO
2014 | Year | 10 | Month | 28 | Day |
Unpublished
Open public recruiting
2014 | Year | 08 | Month | 01 | Day |
2014 | Year | 10 | Month | 28 | Day |
2014 | Year | 10 | Month | 28 | Day |
2014 | Year | 10 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018071
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