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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009340
Receipt No. R000010775
Scientific Title Phase II Feasibility study of Weekly Amrubicin in Patients with Previously Treated Non-small Cell Lung Cancer
Date of disclosure of the study information 2012/11/15
Last modified on 2012/11/13

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Basic information
Public title Phase II Feasibility study of Weekly Amrubicin in Patients with Previously Treated Non-small Cell Lung Cancer
Acronym Weekly Amrubicin in Previously Treated Non-small Cell Lung Cancer
Scientific Title Phase II Feasibility study of Weekly Amrubicin in Patients with Previously Treated Non-small Cell Lung Cancer
Scientific Title:Acronym Weekly Amrubicin in Previously Treated Non-small Cell Lung Cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of weekly amrubicin previously treated non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Adverse events
Key secondary outcomes Disease control rate
Progression-free survival
Overall survival

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 is administered intravenously at a dose of 35 mg/m2/day on days 1,8 and 15 every 4 weeks
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Previously Treated Non-small Cell Lung Cancer
(2) ECOG performance status (PS): 0-2
(3) Sufficient function of main organ and bone marrow filled the following criteria:
Neutrophil counts, 1,000/mm3 or over
Platelets, 50,000/mm3 or over
Hemoglobin, 8.0g/dL or over
AST and ALT, ULN x 3 or less
Serum bilirubin, ULN x 1.5 or less
Serum creatinin, x 1.5mg/dL or less
Adequate heart function by ECG
LVEF (echocardiography), 60% or over
SpO2, 93% or over
(4) Written informed consent from the patients
Key exclusion criteria (1)Patients with active severe infections
(2) Patients with cardiac infarction or necessary cardiac function abnormality of the treatment
(3) Patients with active interstitial pneumonia recognized by chest X-ray or chest CT
(4) Received the maximum allowed cumulative dose of cardiotoxic drugs such as anthracycline derivatives in prior therapy
(5) Inappropriate patients for this study judged by the physicians
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Inagaki
Organization Tsuchiura Kyodo General Hospital
Division name Department of Thoracic Surgery
Zip code
Address 11-7 Manabe-shinmachi, Tsuchiura, Ibaraki, JAPAN
TEL 029-823-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaharu Inagaki
Organization Tsuchiura Kyodo General Hospital
Division name Department of Thoracic Surgery
Zip code
Address 11-7 Manabe-shinmachi, Tsuchiura, Ibaraki, JAPAN
TEL 029-823-3111
Homepage URL
Email masaharu_inagaki@yahoo.co.jp

Sponsor
Institute Tsuchiura Kyodo General 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 総合病院土浦協同病院(茨城県)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 15 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 Open public recruiting
Date of protocol fixation
2012 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 15 Day
Last modified on
2012 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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