UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoichi Nakamura
Organization	Nagasaki University Hospital
Division name	Second Department of Internal Medicine
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	095-819-7273
Email	bomb0416@yahoo.co.jp

Public contact
Name of contact person	Daiki Ogawara
Organization	Nagasaki Goto Chuoh Hospital
Division name	Internal Medicine
Address	205 Yoshikugityo, Goto city, Nagasaki
TEL	0959-72-3181
Homepage URL
Email	bomb0416@yahoo.co.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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