Unique ID issued by UMIN | UMIN000004207 |
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Receipt number | R000005056 |
Scientific Title | A Phase II Study of Erlotinib monotherapy for patients with non-small cell lung cancer wihtout EGFR mutation |
Date of disclosure of the study information | 2010/09/17 |
Last modified on | 2012/08/01 10:40:31 |
A Phase II Study of Erlotinib monotherapy for patients with non-small cell lung cancer wihtout EGFR mutation
A phase II study of Erlotinib for NSCLC wihtout EGFR mutation
A Phase II Study of Erlotinib monotherapy for patients with non-small cell lung cancer wihtout EGFR mutation
A phase II study of Erlotinib for NSCLC wihtout EGFR mutation
Japan |
Non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
YES
TO evaluate efficacy and safety of erlotinib in pretreated patients with NSCLC harboring EGFR wlid type tumor
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Disease contorol rate
Response rate
Overall survival
Progression free survival
Safety
Time to treatment failure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Erlotinib 150 mg/day
20 | years-old | <= |
Not applicable |
Male and Female
1) Hitologically proven NSCLC
2) Patient with recurrent NSCLC of stage IV or after surgery who did not respond to or replapsed prior chemotherapy (<=3).
3) Patients harboring EGFR mutation negative tumor.
4) patients whose tumor tissue are available for EGFR gene copy number, Kras, and cMet.
5) Patients who treated with standard chemotherapy.
6) No prior therapywith EGFR tyrosine kinase inhibitor.
7) ECOG performance status 0-2
8) Patients who have one or more measurable lesion by RECIST.
9) Patiens who ar able to receive treatment by hospitalization for at least 2-4 weeks or under equivalent condition.
10) Age >= 20years at the time ofregestration.
11) adequate organ fuction.
12) Patients who are considered to survive for more than 12 weeks.
13) Patients with written informed consent.
1) severe interstitial lung disease or pulmonary fibrosis.
2) patient with history of drug-related lung disease.
3) Severe drug allrgy.
4) Patients with complication of infectious disease.
5) patients with Severe diarrhea
6) Patients with clinically significant ball disease.
7) patients with clinically significant opthalmologic disorder.
8) patients with complication or hisotry of gastrointestinal perforation.
9) Uncontrolable GI ulcer.
10) Brain metastasis with symptoms
11) Active multiple cancer.
12) patients with clinically significant heart disease.
13) Patients with clinically siginificant psychologic disease.
14) Patients with lactation or pregnancy.
15) patients who are considered ineligible based on decision of a reasonable investigator.
120
1st name | |
Middle name | |
Last name | Kazuo Kasahara |
Kanazawa University Hospital
Respiratory Medicine
Takara-machi, 13-1, Kanazawa, Ishikawa ,920-8641,Japan
076-265-2273
1st name | |
Middle name | |
Last name | Takashi Sone |
Kanazawa University Hospital
Respiratory Medicine
Takara-machi, 13-1, Kanazawa, Ishikawa ,920-8641,Japan
076-265-2273
Hokuriku Lung Cancer Study Group
None
Self funding
NO
2010 | Year | 09 | Month | 17 | Day |
Unpublished
patients are recruiting
Open public recruiting
2010 | Year | 07 | Month | 29 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 14 | Day |
2012 | Year | 08 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005056
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