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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004832
Receipt No. R000005753
Scientific Title Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer
Date of disclosure of the study information 2011/01/06
Last modified on 2011/11/07

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Basic information
Public title Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer
Acronym Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer
Scientific Title Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer
Region
Japan

Condition
Condition Lung Squamous Cell Carcinoma
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of Amrubicin in patients with previously treated Squamous Cell Lung Cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease Control Rate (DCR)
Key secondary outcomes Overall survival (OS)
Progression-free survival (PFS)
Response Rate (RR)
Toxicity profiles

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 1-3 every 3 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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven squamous cell lung cancer.
2) Stage III/IV without indication for curative resection and post-operative recurrent disease
3) Patients who have previously treated with plutimun doublet chemotherapy.
4) Target lesion is measurable(RECISTver1.1)
5) More than 28 days after last chemotherapy and more than 28 days rest period after radiation
6) ECOG performance status 0-1
7) Patients aged 20-74 years
8) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment:
Leukocyte counts, 4,000/mm3 to 12,000/mm3.
Neutrophil counts, 2,000/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.5g/dL or over
AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
Serum bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
Arterial oxygen partial pressure 60 Torr or above.
Adequate heart function by ECG.
LVEF, 60% or over.
9) Written informed consent from the patients
Key exclusion criteria 1) Patients who have previously treated with chemotherapy containing amrubicin.
2) Patients with symptomatic brain metastasis.
3) Patients with massive uncontrolled pleural or pericardial effusion ,or ascites.
4) Patients with active severe infections
5) Patients with double cancer within 5 years.
6) Patients with active interstitial pneumonia recognized by chest X-ray.
7) Patients with serious drug allergic reactions.
8) Patients with active concomitant pregnancy.
9) Patients with cardiac infarction or
unstable angina within 12 months.
Patients need to recieve medications for their bad heart function.
10) Patients who have previously treated with a cumulative daunorubicin dose > 25 mg/kg, doxorubicin >500 mg/m2, epirubicin >900mg/m2, pirarubicin > 950mg/m2.
11) a serious or uncontrolled concomitant systematic disorder (active gastric or duodenal ulcer, uncontrolled diabetes mellitus, or cerebral infarction
within 6 months.)
12) Inappropriate patients for this study judged by the physicians
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name FUNAI Kazuhito
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address 1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code
Address 1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
Homepage URL
Email

Sponsor
Institute First Department of Surgery, Hamamatsu University School of Medicine
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 01 Month 06 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
2010 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 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
2011 Year 01 Month 06 Day
Last modified on
2011 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005753

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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