Unique ID issued by UMIN | UMIN000003215 |
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Receipt number | R000003807 |
Scientific Title | A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations |
Date of disclosure of the study information | 2010/02/20 |
Last modified on | 2010/02/19 20:22:20 |
A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
YES
Objective of the study is to investigate the efficacy and safety of Erlotinib for patients previously treated with chemotherapy career of 1-3 regimens Non-small cell Lung Cancer with EGFR mutation.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
rseponse rate
Evaluation of safety, Progression free survival, Median survival time
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Single agent chemotherapy with Erlotinib
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients having EGFR mutation, stage IIIB, IV or relapsed NSCLC previously treated with 1-3 regimens of chemotherapy.
2) Patients who has measurable lesion.
3) ECOG performance status (PS): 1 or less
4) Patients aged 20 years or older.
5) Sufficient function of main organ and bone marrow filled the following criteria.
WBC >=3,000/mm3
Neu >=1,500/mm3
PLT >=10x104/mm3
Hb >=9.0g/dL
sCr <=1.5mg/dL
GOT,GPT x 2.5 of upper limit of normal or less
T-Bil <=1.5mg/dL
PaO2 >=70torr
6) Patients who are considered to survive for more than 3 months.
7) Patients providing written informed consent.
1)Active infection (fever)
2)Cases with past history of EGFR-TKI
3)Presence of active interstitial lung disease or pulmonary fibrosis
4)Patients with massive pleural or prericardial effusion or ascites
5)Patients with uncontrollable complications
6)Patients with active double cancer
7)Pregnancy or lactation.
8)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
28
1st name | |
Middle name | |
Last name | Hiroki Sakakibara |
Fujita Health Universty Hospital
Division of Respirology and Allergology
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.470-1192
1st name | |
Middle name | |
Last name | Hiroki Sakakibara, Yuji Saito, Yoshitaka Totani |
Fujita Health Universty Hospital
Division of Respirology and Allergology
0562-93-9241
Fujita Health Universty Hospital Division of Respirology and Allergology
none
Self funding
NO
2010 | Year | 02 | Month | 20 | Day |
Unpublished
Enrolling by invitation
2009 | Year | 09 | Month | 02 | Day |
2009 | Year | 11 | Month | 01 | Day |
2010 | Year | 02 | Month | 19 | Day |
2010 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003807
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