UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis
Title of the study (Brief title)	TDM study of Everolimus
Region	Japan

Condition
Condition	1.advanced renal cell carcinoma 2.renal angiomyolipoma associated with tuberous sclerosis complex
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify the association between evelolimus trough level and its adverse events
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Statistical difference of evelolimus trough level between adverse and non-adverse effect
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Everolimus 5mg/day.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients given oral evelolimus more than 5mg daily
Key exclusion criteria	Pregnancy Interstitial lung marking in chest imaging Infection Liver dysfunction
Target sample size	43

Research contact person
Name of lead principal investigator	Ryuichi Mizuno
Organization	Keio University School of Medicine
Division name	Department of Urology
Address	35 Shinanomachi, Shinjyuku, Tokyo
TEL	03-3353-1211
Email	mizunor@z7.keio.jp

Public contact
Name of contact person	Toshiaki Shinojima
Organization	Keio University School of Medicine
Division name	Department of Urology
Address	35 Shinanomachi, Shinjyuku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	t-shinoj@cd5.so-net.ne.jp

Sponsor
Institute	Department of Urology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	慶應義塾大学病院(東京都）、虎の門病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 08 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 08 Month 22 Day
Last modified on	2018 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013524