Unique ID issued by UMIN | UMIN000006381 |
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Receipt number | R000005953 |
Scientific Title | Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma |
Date of disclosure of the study information | 2011/09/21 |
Last modified on | 2020/05/28 19:20:41 |
Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma
Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma
Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma
Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma
Japan |
Malignant pleural mesothelioma
Pneumology |
Malignancy
YES
To evaluate the efficacy and the safety of amrubicin therapy in pleviously treated patients with malignant pleural mesothelioma
Safety,Efficacy
Response rate
Progression-free survival
Overall survival
safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Amrubicin 35mg/m2 on day1-3
20 | years-old | <= |
Not applicable |
Male and Female
1.Histologically or cytologically proven malignant pleural mesothelioma
2.Patients who were not candidates for curative surgery
3.Previously treated with chemotherapy
4.A life expectancy of 12 weeks or more
5.Measurable by RECST criteria
6.Age: >=20 years old
7.ECOG performance status of 0 or 1
8.Adequate bone marrow, liver and renal functions
WBC >4000/mm3, Hb > 9.0g/dl, PLT >100,000/mm3, Total bilirubin < 1.5mg/dl, GOT,GPT < 2x upper normal limit, Serum creatinine ≤ upper normal limit
9.Written informed consent
1.Symptomatic pericardial effusion
2.Symptomatic SVC syndrome required emergency radiation
3.Serious medical complications
4.Uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure
5.Uncontrolled diabetes mellitus, hypertension, infection
6.Pulmonary fibrosis detectable on chest X ray films
7.Concomitant malignancy
8.Pregnant or milk-feeding female
9.Symptomatic brain metastasis
10.Other clinical difficulties to this study
32
1st name | |
Middle name | |
Last name | Yoichi Nakamura |
Nagasaki University Hospital
Second department of Internal Medicine
1-7-1 Sakamoto, Nagasaki, Japan
1st name | |
Middle name | |
Last name |
Nagasaki University Hospital
Second department of Internal Medicine
1-7-1 Sakamoto, Nagasaki, Japan
Nagasaki University Hospital
none
Self funding
NO
2011 | Year | 09 | Month | 21 | Day |
Unpublished
Completed
2011 | Year | 08 | Month | 20 | Day |
2011 | Year | 12 | Month | 12 | Day |
2011 | Year | 09 | Month | 01 | Day |
2017 | Year | 11 | Month | 01 | Day |
2020 | Year | 05 | Month | 28 | Day |
2011 | Year | 09 | Month | 21 | Day |
2020 | Year | 05 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005953
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