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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003282
Receipt No. 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

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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
Email 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
Email bomb0416@yahoo.co.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003973

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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