UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002970 |
|---|---|
| Receipt number | 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 11:38:43 |
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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
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
ymakino@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003603
