UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002895 |
|---|---|
| Receipt number | R000003527 |
| Scientific Title | nilotinib pharmacokinetics correlation with clinical response and adverse events in chronic myelogenous leukemia |
| Date of disclosure of the study information | 2009/12/14 |
| Last modified on | 2021/06/29 12:36:15 |
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Basic information
Public title
nilotinib pharmacokinetics correlation with clinical response and adverse events in chronic myelogenous leukemia
Acronym
nilotinib pahrmacokinetics in Japanese CML patients
Scientific Title
nilotinib pharmacokinetics correlation with clinical response and adverse events in chronic myelogenous leukemia
Scientific Title:Acronym
nilotinib pahrmacokinetics in Japanese CML patients
Region
| Japan |
Condition
Condition
chronic myelogenous leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Correlate trough levels of nilotinib with clinical response and AE
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
nilotinib pahrmacokinetics in Japanese CML patients
Key secondary outcomes
clinical response
adverse events
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.Chronic myelogenous leukemia in chronic-phase and accerated-phase.
2.Age =>20 year
3.PS 0-2(ECOG)
4.No severe major organ dysfunction (AST,ALT, creatinine <3.0x ULN)
5.Written informed consent
Key exclusion criteria
1.Patients suspected in blast crisis
2.History of a invasive double cancer within 5 years before
3.Pregnant and/or lactating woman
4.Severe psychological disorders
5.Uncontorlled complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Okada |
Organization
Hyogo College of Medicine
Division name
Division of Hematology, Department of Internal Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6886
masaya@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Okada |
Organization
hyogo college of medicine
Division name
Division of Hematology, Department of Internal Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6886
Homepage URL
masaya@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine/Division of Hematology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine/Division of Hematology, Department of Internal 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
Hyogo college of medicine
Address
mukogawa-cho 1-1
Tel
+81798456886
masaya@hyo-med.ac.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
| 2009 | Year | 12 | Month | 14 | 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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The measurement of the nilotonib trolugh level
1.clinical response(3M,6M,12M)
2.point of adverse events
Management information
Registered date
| 2009 | Year | 12 | Month | 14 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003527
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
