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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021999
Receipt No. R000025350
Scientific Title Personalized therapy for pazopanib
Date of disclosure of the study information 2016/04/20
Last modified on 2016/04/20

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Basic information
Public title Personalized therapy for pazopanib
Acronym Personalized therapy for pazopanib
Scientific Title Personalized therapy for pazopanib
Scientific Title:Acronym Personalized therapy for pazopanib
Region
Japan

Condition
Condition Malignant soft tissue tumor
Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the pharmacokinetics, efficacy, and side effects of pazopanib in patients with malignant soft tissue tumor or renal cell carcinoma
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare blood concentration, efficy and adverse events of pazopanib
Key secondary outcomes To evaluate factors that affect the blood concentration of pazopanib

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 Patients receiving pazopanib for malignant soft tissue tumor or renal cell carcinoma
Key exclusion criteria No
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nariyasu Mano
Organization Tohoku university hospital
Division name Department of pharmaceutical sciences
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
TEL 022-717-7525
Email mano@hosp.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Yamaguchi
Organization Tohoku university hospital
Division name Department of pharmaceutical sciences
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
TEL 022-717-7528
Homepage URL
Email yamaguchi@hosp.tohoku.ac.jp

Sponsor
Institute Department of pharmaceutical sciences, Tohoku university hospital
Institute
Department

Funding Source
Organization Management expenses grants
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of urology, Tohoku university hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 04 Month 20 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
2016 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 Patients who were admitted to our hospital urology, met the selection criteria on or after April 1, 2016

Management information
Registered date
2016 Year 04 Month 20 Day
Last modified on
2016 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025350

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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