UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034349 |
|---|---|
| Receipt number | R000038867 |
| Scientific Title | Pharmacokinetic study of lenvatinib suspension by a simple suspension method in thyroid cancer patients |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2019/04/02 09:19:16 |
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Basic information
Public title
Pharmacokinetic study of lenvatinib suspension by a simple suspension method in thyroid cancer patients
Acronym
Pharmacokinetic study of lenvatinib suspension
Scientific Title
Pharmacokinetic study of lenvatinib suspension by a simple suspension method in thyroid cancer patients
Scientific Title:Acronym
Pharmacokinetic study of lenvatinib suspension
Region
| Japan |
Condition
Condition
Thyroid cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the pharmacokinetic profiles of cases taking lenvatinib capsules and cases taking lenvatinib suspension using the simple suspension method. In addition, we compare the pharmacokinetic parameters of the two groups, and evaluate the effect of the simple suspension method on the pharmacokinetics of lenvatinib.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetic parameters (AUC, Cmax, Tmax)
Key secondary outcomes
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) Patients diagnosed with unresectable thyroid cancers and treated with lenvatinib
2) Patients with adequate organ (liver and kidney) function for lenvatinib treatment
3) Patients aged 20 years or over
4) Patients with written informed consent
Cohort: Group of patients taking lenvatinib capsules
1) Patients who can take 24 mg lenvatinib capsules
Cohort: Group of patients taking lenvatinib suspension
1) Patients who can take lenvatinib suspension by the simple suspension method due to difficulty in swallowing
Key exclusion criteria
1) Patients known to be positive for human immunodeficiency virus
2) Patients determined difficult to be included in this study based on investigator's judgement
3) Women who are pregnant,possibily pregnant, or breastfeeding
4) Patients with serious psychiatric condition
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Morita |
Organization
National Cancer Center Hospital East
Division name
Department of Pharmacy
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-0882 Japan
TEL
04-7133-1111
toogawa@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Sano |
Organization
National Cancer Center Hospital East
Division name
Department of Pharmacy
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-0882 Japan
TEL
04-7133-1111
Homepage URL
yosano@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Foundation for promotion of cancer research in Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan
Tel
04-7133-1111
ncc@esct.bvits.com
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
国立がん研究センター東病院(千葉県)、神戸大学医学部付属病院(兵庫県)、愛知県がんセンター中央病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | 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 | 08 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate the pharmacokinetic profiles of cases taking lenvatinib capsules and cases taking lenvatinib suspoension using the simple suspension method.
Management information
Registered date
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038867
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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