UMIN-CTR Clinical Trial

Basic information
Public title	Phase II trial of amrubicin treatment as palliative-intended chemotherapy for previously treated malignant pleural mesothelioma
Acronym	Phase II study of amrubicin for previously treated malignant pleural mesothelioma
Scientific Title	Phase II trial of amrubicin treatment as palliative-intended chemotherapy for previously treated malignant pleural mesothelioma
Scientific Title:Acronym	Phase II study of amrubicin for previously treated malignant pleural mesothelioma
Region	Japan

Condition
Condition	malignant pleural mesothelioma
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate for efficacy and toxicities of amrubicin monotherapy for previously treated 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, toxicities, number of cycles

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/m^2 (day 1-3) every 3-weeks until tumor progression and unacceptable toxicities
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Definitively diagnosed with having previously untreated advanced non-small cell lung cancer by the specimens histologically or cytologically. 2) Age of more than 70 years-old 3) With adequate organ function of bone marrow reserve, liver, and kidney. (1) PS 0-1 (2) neutrophil count => 1,500/mm^3 (3) platelet => 100,000/mm^3 (4) hemoglobin => 9.0g/dL (5) AST/ALT < 2.5 times less than ULN (6) T.Bil <= 1.5mg/dL (7) serum creatinine <= 1.5mg/dL (8) ECG: without clinically problematic abnorbomalities (9) Peripheral neuropathy <= Grade 1 (10) SpO2 (room air) more than 92% 4) With the status of below previous treatment at the time of beginning of chemotherapy. (1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation (2) Surgical procedure, including pleurodesis or pleural drainage * more than 8 weeks with lobectomy * more than 4 weeks without lobectomy, including exploratory thoracotomy * more than 2 weeks after completing procedure (pleurodesis or pleural drainage) 5) With expected prognosis more than 12 weeks 6) With written informed consent
Key exclusion criteria	1) The age of less than 70 years-old 2) Previously treated with chemotherapy 3) With uncontrolled brain metastasis 4) With clinically active infection 5) With severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 6) With uncontrolled pleural effusion 7) With active other organ cancer 8) With the history of severe drug allergy 9) With the history of hypersensivity for paclitaxel, albumin-containing agents 10) With the history of hypersensitivity for platinum agents 11) With uncontrolled digestive ulcer 12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	26

Research contact person
Last name of lead principal investigator	1st name Yukio Middle name Last name Hosomi
Organization	Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Zip code	113-8677
Address	22, Honkomagome, Bunkyo Tokyo
TEL	03-3823-2101
Email	yhosomi@cick.jp

Public contact
1st name of contact person	1st name Yusuke Middle name Last name Okuma
Organization	Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Division name	Department of Thoracic Oncology and Respiratory Medicine
Zip code	113-8677
Address	3-18-22, Honkomagome, Bunkyo Tokyo
TEL	03-3823-2101
Homepage URL
Email	y-okuma@cick.jp

Sponsor
Institute	Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
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	Ethics committee of Tokyo Metropolitan Komagome Hospital
Address	Honkomagome 3-18-22, Bunkyo, Tokyo
Tel	03-3823-2101
Email	rinri@cick.jp

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	2013 Year 05 Month 16 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	6
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	Terminated
Date of protocol fixation	2013 Year 06 Month 25 Day
Date of IRB	2013 Year 06 Month 25 Day
Anticipated trial start date	2013 Year 06 Month 25 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 05 Month 16 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012544