UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma
Acronym	Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma
Scientific Title	Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma
Scientific Title:Acronym	Phase 2 study of amrubicin in previously treated patients with malignant pleural mesothelioma
Region	Japan

Condition
Condition	Malignant pleural mesothelioma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of amrubicin therapy in pleviously treated patients with malignant pleural mesothelioma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression-free survival Overall survival safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Amrubicin 35mg/m2 on day1-3
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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 &#8804; upper normal limit 9.Written informed consent
Key exclusion criteria	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
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoichi Nakamura
Organization	Nagasaki University Hospital
Division name	Second department of Internal Medicine
Zip code
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Nagasaki University Hospital
Division name	Second department of Internal Medicine
Zip code
Address	1-7-1 Sakamoto, Nagasaki, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 09 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 20 Day
Date of IRB	2011 Year 12 Month 12 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2017 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 05 Month 28 Day

Other
Other related information

Management information
Registered date	2011 Year 09 Month 21 Day
Last modified on	2020 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005953