UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009340 |
|---|---|
| Receipt number | 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 20:52:18 |
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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
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
masaharu_inagaki@yahoo.co.jp
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010775
