UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000071
Receipt number R000000118
Scientific Title Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy
Date of disclosure of the study information 2005/08/22
Last modified on 2015/08/31 15:27:43

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Basic information

Public title

Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy

Acronym

Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy

Scientific Title

Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy

Scientific Title:Acronym

Phase II Study of Amrubicin in Patients with Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy

Region

Japan


Condition

Condition

All patients had histologocally or cytologically confirmed locally advanced (non-irradiated) or metastatic NSCLC, with failure of platinum-based chemotherapy (exception for UFT and gefitinib).

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate safety and efficacy of amrubicin in patients with non-small cell lung cancer who had failed platinum-based chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall response rate (according to RECIST criteria)

Key secondary outcomes



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 was given at 40mg/m2 intravenously over 5 minutes for three consecutive days, every 3 weeks

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

All patients had histologocally or cytologically confirmed locally advanced (non-irradiated) or metastatic NSCLC, with failure of platinum-based chemotherapy (exception for UFT and gefitinib). Before study entry, at least 4 weeks must have elapsed since any prior chemotherapy or radiotherapy. Patients had to have measurable disease, a Eastern Cooporative Oncology Group (ECOG) performance status 0 or 1, and be aged between 20 and 74 years. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.

Key exclusion criteria

The exclusion criteria consisted of pulmonary fibrosis or interstitial pneumonitis with symptoms or apparent abnormalities on chest X-ray, massive pleural effusion, pericardial effusion, or ascites, pregnancy, lactation, symptomatic brain metastases, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, severe superior vena cava syndrome, uncontrollable diabetes mellitus, severe infection, or active peptic ulcer. Patients who have prior receive amrubicin and other anthracycline drugs were excluded, too.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Uejima

Organization

Izumisano Municipal Hospital, Rinku General Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

2-23 Rinkuoraikita, Izumisano, Osaka, 598-0048, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code


Address


TEL

06-6633-7400

Homepage URL


Email

datacenter@wjog.jp


Sponsor or person

Institute

West Japan Oncology 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


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

2005 Year 08 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed?term=19884859

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

2004 Year 12 Month 18 Day

Date of IRB


Anticipated trial start date

2005 Year 02 Month 01 Day

Last follow-up date

2009 Year 02 Month 01 Day

Date of closure to data entry

2009 Year 02 Month 01 Day

Date trial data considered complete

2009 Year 02 Month 01 Day

Date analysis concluded

2009 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 22 Day

Last modified on

2015 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000118


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name