UMIN ID: UMIN000002306
Registered date:07/08/2009
Phase II study of amrubicin for non-small lung cancer after failure of two or three prior chemotherapy regimens
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | NSCLC after failure of two or three prior chemotherapy regimes |
Date of first enrollment | 2009/08/01 |
Target sample size | 40 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Amrubicin 35mg/m2 is administered from day 1 to day 3 |
Outcome(s)
Primary Outcome | Disease control rate |
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Secondary Outcome | Overall survival, Progression-free survival, Objective response rate, Safety |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1)Drug allergy career with inappropriateness for participation to this study 2)Infectious disease or fever of >= 38 degrees Celsius that interferes to this treatment 3)Using oral steroid or immunosuppressive drug 4)Serious medical complications (severe heart disease/cerebrovascular disorder, severe hypertension, active digestive ulcer, uncontrolled diabetes mellitus etc.) 5)Interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray film or CT scan 6)Previous amrubicin use 7)Exceeding critical dosage in prior treatment by the drug with cardiac toxicity such as anthracycline drugs 8)Requirement of emergent therapy for pleural effusion, ascites, and pericardial effusion 9)Symptomatic brain metastasis 10)Concomitant malignancy 11)Heart disease that becomes obstacle for this sutdy 12)Psychological/mental illness that becomes obstacle for participation to this sutdy inappropriateness for participation to this study 13)Pregnant, milk-feeding, possibility becoming pregnant female 14)Other clinical inappropriateness to this study |
Related Information
Primary Sponsor | Hokkaido Lung Cancer Clinical Study Group |
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Secondary Sponsor | |
Source(s) of Monetary Support | Self funding |
Secondary ID(s) |
Contact
public contact | |
Name | Toshiyuki Harada |
Address | 3-18, 1-8, Nakanoshima, Toyohira-ku, Sapporo Japan |
Telephone | 011-831-5151 |
t-harada@hok-shaho-hsp.jp | |
Affiliation | Hokkaido Social Insurance Hospital Center of Respiratory Diseases |
scientific contact | |
Name | Toshiyuki Harada |
Address | 3-18, 1-8, Nakanoshima, Toyohira-ku, Sapporo Japan |
Telephone | 011-831-5151 |
Affiliation | Hokkaido Social Insurance Hospital Center of Respiratory Diseases |