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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002970
Receipt No. R000003603
Scientific Title Genetic polymorphisms of metabolizing enzymes and transporters correlate with pharmacokinetics (PK) and pharmacodynamics (PD) of amrubicin
Date of disclosure of the study information 2010/01/04
Last modified on 2018/10/31

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Basic information
Public title Genetic polymorphisms of metabolizing enzymes and transporters correlate with pharmacokinetics (PK) and pharmacodynamics (PD) of amrubicin
Acronym PK/PD and PGx study of Amrubicin
Scientific Title Genetic polymorphisms of metabolizing enzymes and transporters correlate with pharmacokinetics (PK) and pharmacodynamics (PD) of amrubicin
Scientific Title:Acronym PK/PD and PGx study of Amrubicin
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 pharmacokinetics of amrubicin
Basic objectives2 Others
Basic objectives -Others To assess whether genetic polymorphisms correlate with PK/PD of Amrubicin
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes PK parameter of amrubicin and active metabolite amrubicinol
Key secondary outcomes PK parameters correlate with Hematological toxicity

Genetic polymorphisms correlate with PK/PD

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 patients is recieved amrubicin
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

Not applicable
Gender Male and Female
Key inclusion criteria lung cancer
Informed consent is given
Key exclusion criteria possitive HIV and HCV, and Hbs

Patients whose participation inthe trial is judged to be inappropriate by the attending doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Yamamoto
Organization National Cancer Center Hospital
Division name Department of Pharmacy
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Makino
Organization National Cancer Center Hospital
Division name Department of Pharmacy
Zip code
Address
TEL
Homepage URL
Email ymakino@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization
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
2010 Year 01 Month 04 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
2008 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 08 Month 23 Day
Date analysis concluded
2018 Year 08 Month 23 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 04 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003603

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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