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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002306
Receipt No. R000002819
Scientific Title Phase II study of amrubicin for non-small lung cancer after failure of two or three prior chemotherapy regimens
Date of disclosure of the study information 2009/08/07
Last modified on 2012/08/07

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Basic information
Public title Phase II study of amrubicin for non-small lung cancer after failure of two or three prior chemotherapy regimens
Acronym Phase II study of Third-line AMR for NSCLC
Scientific Title Phase II study of amrubicin for non-small lung cancer after failure of two or three prior chemotherapy regimens
Scientific Title:Acronym Phase II study of Third-line AMR for NSCLC
Region
Japan

Condition
Condition NSCLC after failure of two or three prior chemotherapy regimes
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety for NSCLC after failure of two or three prior chemotherapy regimes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease control rate
Key secondary outcomes Overall survival, Progression-free survival, Objective response rate, 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 is administered from day 1 to day 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

Not applicable
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically proven non-small cell lung cancer
2)Failure of two or three prior chemotherapy regimens containing platinum drug (CDDP or CBDCA) combination (including molecular target drug or adjuvant chemotherapy)
3)With measurable lesion
4)ECOG performance status of 0 to 2
5)Under 75 years
6)Adequate bone marrow, lung, liver, renal, and heart functions
WBC >= 3,0000 mm-3
Neutro >= 1,500 mm-3
Hb >= 9 g dL-1
Platlets >= 100,000 mm-3
T-Bil <= 1.5 mg dL-1
AST, ALT <= two times of institutional normal value
Ccr >= 50 mL min-1
PaO2 >= 60torr (or SpO2 >= 95%)
LVEF >= 60%
7)Life expectancy of 3 months or more
8)Written informed consent for participation to this study
Key exclusion criteria 1)Drug allergy career with inappropriateness for participation to this study
2)Infectious disease or fever of >= 38 degrees Celsius that interferes to this treatment
3)Using oral steroid or immunosuppressive drug
4)Serious medical complications (severe heart disease/cerebrovascular disorder, severe hypertension, active digestive ulcer, uncontrolled diabetes mellitus etc.)
5)Interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray film or CT scan
6)Previous amrubicin use
7)Exceeding critical dosage in prior treatment by the drug with cardiac toxicity such as anthracycline drugs
8)Requirement of emergent therapy for pleural effusion, ascites, and pericardial effusion
9)Symptomatic brain metastasis
10)Concomitant malignancy
11)Heart disease that becomes obstacle for this sutdy
12)Psychological/mental illness that becomes obstacle for participation to this sutdy
inappropriateness for participation to this study
13)Pregnant, milk-feeding, possibility becoming pregnant female
14)Other clinical inappropriateness to this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Harada
Organization Hokkaido Social Insurance Hospital
Division name Center of Respiratory Diseases
Zip code
Address 3-18, 1-8, Nakanoshima, Toyohira-ku, Sapporo
TEL 011-831-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Harada
Organization Hokkaido Social Insurance Hospital
Division name Center of Respiratory Diseases
Zip code
Address 3-18, 1-8, Nakanoshima, Toyohira-ku, Sapporo
TEL 011-831-5151
Homepage URL
Email t-harada@hok-shaho-hsp.jp

Sponsor
Institute Hokkaido Lung Cancer Clinical Study Group
Institute
Department

Funding Source
Organization Self funding
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 北海道社会保険病院

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2012 Year 12 Month 31 Day
Date analysis concluded
2012 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 07 Day
Last modified on
2012 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002819

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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