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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034349
Receipt No. 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

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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
Email 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
Email yosano@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038867

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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