UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014019 |
|---|---|
| Receipt number | R000014349 |
| Scientific Title | Phase II Study of Amrubicin and Paclitaxel in Previously Treated Lung Cancer Patients |
| Date of disclosure of the study information | 2014/05/21 |
| Last modified on | 2016/03/28 20:39:16 |
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Basic information
Public title
Phase II Study of Amrubicin and Paclitaxel in Previously Treated Lung Cancer Patients
Acronym
Phase II Study of Amrubicin and Paclitaxel in Previously Treated Lung Cancer Patients
Scientific Title
Phase II Study of Amrubicin and Paclitaxel in Previously Treated Lung Cancer Patients
Scientific Title:Acronym
Phase II Study of Amrubicin and Paclitaxel in Previously Treated Lung Cancer Patients
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine RD of AMR+PTX for LC patients previously treated with chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
RR
Key secondary outcomes
safety, PFS, OS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
AMR 30mg/m2 day1-3, PTX 70mg/m2 day4,11 repeat every 3 weeks for minimum 2 cycles.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 histologically or cytologically confirmed NSCLC
2 recurrent patients treated with 1 or 2 regimens
3 measurable disease
4 life expectancy of at least 3 months.
5 >70 age years >=20
6 performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
7 adequate organ function
adequate bone marrow (leukocyte count 12,000>= >=3,000/mm3, neutrophil count > =1,500/mm3, hemoglobin concentration > =9.5g/dL, platelet count >= 100,000 /mL), kidney (creatinine <= 1.2 mg/dL), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =100, total bilirubin <= 2.0 mg/dL)
Key exclusion criteria
1 active concomitant malignancies,infections
2 symptomatic brain metastases
3 past history of severe allergic reactions to drugs
4 interstitial pneumonia identified by chest X-ray
5 bone metastasis or hypercalcemia required immediate treatment
6 other serious complications, such as uncontrolled angina pectoris,myocardial infarction, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.
7 allergie for PTX
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
hy0522@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Yoshizawa |
Organization
Niigata University Medical and Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL
025-227-2517
Homepage URL
hy0522@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 21 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014349
