Unique ID issued by UMIN | UMIN000013350 |
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Receipt number | R000015578 |
Scientific Title | Phase 2 study of amrubicin plus bevacizumab in patients with previously treated advanced non-sq NSCLC |
Date of disclosure of the study information | 2014/03/06 |
Last modified on | 2014/03/06 11:02:28 |
Phase 2 study of amrubicin plus bevacizumab in patients with previously treated advanced non-sq NSCLC
Phase 2 study of amrubicin plus bevacizumab in patients with previously treated advanced non-sq NSCLC
Phase 2 study of amrubicin plus bevacizumab in patients with previously treated advanced non-sq NSCLC
Phase 2 study of amrubicin plus bevacizumab in patients with previously treated advanced non-sq NSCLC
Japan |
Non small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate the efficacy and safety of amrubicin plus bevacizumab in patients with previously treated advanced non-sq NSCLC.
Safety,Efficacy
Progression free survival
Overall Response Rate
Disease Control Rate
Overall Survival
Safety, Toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Amurubicin 35mg/m2 day1-3
Bevacizumab 15mg/kg day1 q3w
20 | years-old | <= |
Not applicable |
Male and Female
1.Histologically and/or cytologically proven nonsquamous NSCLC
2.Unresectable clinical stage IV
3.Patients who have previously treated with chemotherapy (within 2 rejimens included bevacizumab. Prior EGFR TKI and ALK inhibitor treatment are not counted for 1 rejimen.)
4. Measurable or evaluable disease for RECIST 1.1.
1. Symptomatic brain metastases
2. History of bleeding
3. Patient with active infection
4. Fever over 38
5. Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc)
6. Obvious interstitial pneumonia , fibroid lung confirmed by CT.
7.Patient with much ascetic fluid, pleural effusion, cardiac effusion.
8. Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ)
9. History of severe drug allergy
10.Patient with gastrointestinal perforation within 1 year.
11. Patient thought as of high risk of bleeding (Obvious tumor invasion to main thoracic vessel and cavity) and of thromboembolizm.
12. Receiving anticoagulant therapy. (Aspirin 325mg or less to allow)
13. History of amurubicin treatment, or other anthracycline treatment within upper limit cardiac toloreated dose(daunorubicin: 25mg/kgdoxorubicin: 500mg/m2, Epilbicine: 900mg/m2: pirarubicin: 900mg/m2, etc)
14. Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities.
15. Considered to be interfere to the agreement or understanding the protocol by attening doctor.
16. Patient with impaired mental status.
17. Pregnancy
18. Other ineligible status judged by attending doctor.
40
1st name | |
Middle name | |
Last name | Kyouichi Kaira |
Gunma University Graduate School of Medicine
Oncology Clinical Development
3-39-15, Shouwa-town, Maebashi-city, Gunma
027-220-8136
kkaira1970@yahoo.co.jp
1st name | |
Middle name | |
Last name | Kyouichi Kaira |
Gunma University Graduate School of Medicine
Oncology Clinical Development
3-39-15, Shouwa-town, Maebashi-city, Gunma
027-220-8136
kkaira1970@yahoo.co.jp
Gunma University Graduate School of Medicine
none
Other
NO
2014 | Year | 03 | Month | 06 | Day |
Unpublished
Open public recruiting
2014 | Year | 01 | Month | 25 | Day |
2014 | Year | 02 | Month | 10 | Day |
2014 | Year | 03 | Month | 06 | Day |
2014 | Year | 03 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015578
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