UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011559 |
|---|---|
| Receipt number | R000013524 |
| Scientific Title | Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2018/02/24 09:34:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis
Acronym
TDM study of Everolimus
Scientific Title
Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ryuichi Mizuno |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
03-3353-1211
mizunor@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Shinojima |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
03-3353-1211
Homepage URL
t-shinoj@cd5.so-net.ne.jp
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013524
