UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035292 |
|---|---|
| Receipt number | R000040208 |
| Scientific Title | A Multicenter study on the proper use and safety of ponatinib based on PK/PD/PGx |
| Date of disclosure of the study information | 2018/12/17 |
| Last modified on | 2019/06/13 11:52:04 |
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Basic information
Public title
A Multicenter study on the proper use and safety of ponatinib based on PK/PD/PGx
Acronym
A Multicenter study on the proper use and safety based on PK/PD/PGx
Scientific Title
A Multicenter study on the proper use and safety of ponatinib based on PK/PD/PGx
Scientific Title:Acronym
A Multicenter study on the proper use and safety based on PK/PD/PGx
Region
| Japan |
Condition
Condition
chronic myeloid leukemia, Ph1 positive acute lymphoblastic leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore the predictive factors of adverse events for the patients who receive ponatinib by PK/PD/PGx analysis
Basic objectives2
Others
Basic objectives -Others
Feasibility Study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to vascular occlusive event
Key secondary outcomes
Complete hematologic response, Complete cytogentic response, Major molecular response, Drug concentration
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patient has been diagnosed with any of the following by chtomosome or genetic test:i)CML-CP,ii)CML-AP,iii)CML-BC,iv)Ph+ALL.
2) Patient who has been registered to post marketing surveillance of ponatinib.
3) Age at registration is of 20 years or older.
4) Written informed consent is taken.
Key exclusion criteria
None
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yousuke |
| Middle name | |
| Last name | Minami |
Organization
National Cancer Center Hospital East
Division name
Department of Hematology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shiChiba, Japan, 277-8577
TEL
0471331111
yominami@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Miyamoto |
Organization
National Cancer Center Hospital East
Division name
Department of Hematology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shiChiba, Japan, 277-8577
TEL
0471331111
Homepage URL
kenmiyam@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba
Tel
04-7133-1111
IRBsupport@east.ncc.go.jp
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
| 2018 | Year | 12 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040208
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
