UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002306 |
|---|---|
| Receipt number | 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 14:30:02 |
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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
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
t-harada@hok-shaho-hsp.jp
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002819
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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