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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000141
Receipt No. R000000209
Scientific Title A phase II study of Amrubicin in patients with previously treated small cell lung cancer
Date of disclosure of the study information 2005/09/08
Last modified on 2005/09/08

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Basic information
Public title A phase II study of Amrubicin in patients
with previously treated small cell lung cancer
Acronym A phase II study of Amrubicin in patients
with previously treated small cell lung cancer
Scientific Title A phase II study of Amrubicin in patients
with previously treated small cell lung cancer
Scientific Title:Acronym A phase II study of Amrubicin in patients
with previously treated small cell lung cancer
Region
Japan

Condition
Condition small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of amrubicin in the patients with previously treated small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
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 40 mg/m2 on days 1, repeated every 21 days.
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 Histologically or cytologically confirmed SCLC
Stage IIIB/IV
Prior one or two regimens
Measurable disease
ECOG PS 0-1
Adequate organ function
Age 20-74
Written informed consent
Key exclusion criteria Pregnancy or breast feeding
Past history of drug hypersensitivity
SVC syndrome
Pleural or pericardial effusion that required drainage
Active infection
Interstitial pneumonia or active lung fibrosis
Symptomatic brain metastasis
Active concomitant malignancy
Uncontrolled diabetes
Uncontrolled heart disease

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isamu Okamoto
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama,
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University School of Medicine
Division name Department of Medical Oncology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kinki University School of Medicine
Institute
Department

Funding Source
Organization Department of Medical Oncology,
Kinki University School of Medicine
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 09 Month 08 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
Date of protocol fixation
2005 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 09 Month 08 Day
Last modified on
2005 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000209

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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