UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003282 |
|---|---|
| Receipt number | R000003973 |
| Scientific Title | Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2010/03/03 |
| Last modified on | 2016/05/17 12:02:47 |
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Basic information
Public title
Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer
Acronym
Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer
Scientific Title
Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer
Scientific Title:Acronym
Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non-Small-Cell Lung Cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine MTD and to assess the efficacy and safety of amrubicin and nedaplatin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
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
Nedaplatin 100mg/m^2 on day 1, Amrubicin 25-40mg/m^2 on day 1,2 and 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.Stage IIIB and Stage IV postoperative recurrence
3.no previous chemotherapy
4.a life expectancy of 12 weeks or more
5.Measurable by RECST criteria (Phase 2)
6.age range under 75 years
7.ECOG performance status of 0 or 1
8.adequate bone marrow, liver, and renal functions
WBC > 4000 mm-3
Hb > 9.0 g/dL-1
T-Bil< 1.5 mg dL-1
AST, ALT< 2x upper normal limit
s-Cr < upper normal limit
9.Written informed consent
Key exclusion criteria
1.Symptomatic pericardial effusion
2.Symptomatic SVC syndrome required emergency radiation
3.Serious medical complications
4.uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure.
5.Uncontrolled diabetes mellitus, hypertension, infection
6.Pulmonary fibrosis detectable on chest X-ray films
7.Concomitant malignancy
8.Pregnant or milk-feeding female
9.Symptomatic brain metastasis
10.Other clinical difficulties to this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Nakamura |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL
095-819-7273
bomb0416@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daiki Ogawara |
Organization
Nagasaki Goto Chuoh Hospital
Division name
Internal Medicine
Zip code
Address
205 Yoshikugityo, Goto city, Nagasaki
TEL
0959-72-3181
Homepage URL
bomb0416@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University 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
none
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
長崎大学病院(長崎県)、日赤長崎原爆病院(長崎県)、長崎県島原病院(長崎県)、長崎県五島中央病院(長崎県)、佐世保市立総合病院(長崎県)、国立長崎医療センター(長崎県)、嬉野医療センター(佐賀県)、健康保険諫早総合病院(長崎県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 03 | 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 02 | Day |
Last modified on
| 2016 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003973
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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