UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001752
Receipt number R000002111
Scientific Title A phase II study of amrubicin for previously treated small cell lung cancer
Date of disclosure of the study information 2009/03/05
Last modified on 2014/03/06 10:04:40

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Basic information

Public title

A phase II study of amrubicin for previously treated small cell lung cancer

Acronym

Amrubicin for previously treated small cell lung cancer

Scientific Title

A phase II study of amrubicin for previously treated small cell lung cancer

Scientific Title:Acronym

Amrubicin for previously treated small cell lung cancer

Region

Japan


Condition

Condition

For patients with recurrent small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safty of amrubicin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Safety, Overall survival, Progression-free 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 from day 1 to day 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically proven small cell lung cancer
2)age range from 20 years
3)ECOG performance status of 0 or 2
4)a life expectancy of 8 weeks or more
5)Measurable by RECST criteria
6)Previous treatment with two regimens is allowed.
7)adequate bone marrow, liver, and renal functions
WBC > 4000 mm-3
Neutro > 2000 mm-3
Platlets > 100000 mm-3
Hb > 9 g dL-1
T-Bil< 1.5 mg dL-1
AST, ALT<100IU/L
s-Cr < 1.5 mg dL-1
CCr > 60 mL min-1
PaO2>60torr
8)Written informed consent

Key exclusion criteria

1)Pulmonary fibrosis detectable on chest X-ray films
2)Massive pleural effusion, ascites and pericardial effusion required drainage
3)Concomitant malignancy
4)Serious medical complications: uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infection (ileus, bleeding, superior vena cava syndrome
5)Symptomatic brain metastasis
6)Pregnant or milk-feeding female. Intention to be pregnant in the future
7)With severe allergy
8)Other clinical difficulties to this study

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Sunaga

Organization

Gunma University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

3-39-15 showa-machi, Maebashi, Gunma 371-0014, Japan

TEL

027-220-7111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Sunaga

Organization

Gunma University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

3-39-15 showa-machi, Maebashi, Gunma 371-0014, Japan

TEL

027-220-7111

Homepage URL


Email

nsunaga@showa.gunma-u.ac.jp


Sponsor or person

Institute

Gunma 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


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



Other administrative information

Date of disclosure of the study information

2009 Year 03 Month 05 Day


Related information

URL releasing protocol


Publication of results

Published


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

2007 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2007 Year 10 Month 01 Day

Last follow-up date

2010 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2012 Year 11 Month 22 Day


Other

Other related information



Management information

Registered date

2009 Year 03 Month 04 Day

Last modified on

2014 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002111


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name