UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014685 |
|---|---|
| Receipt number | R000017073 |
| Scientific Title | A prospective study comparing the pharmacokinetics, efficacy, and side effects of sunitinib in patients with advanced renal cell carcinoma |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2018/08/02 07:28:09 |
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Basic information
Public title
A prospective study comparing the pharmacokinetics, efficacy, and side effects of sunitinib in patients with advanced renal cell carcinoma
Acronym
Pharmacokinetics of sunitinib in patients with advanced renal cell carcinoma
Scientific Title
A prospective study comparing the pharmacokinetics, efficacy, and side effects of sunitinib in patients with advanced renal cell carcinoma
Scientific Title:Acronym
Pharmacokinetics of sunitinib in patients with advanced renal cell carcinoma
Region
| Japan |
Condition
Condition
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 sunitinib in patients with advanced renal cell carcinoma
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between trough concentrations of sunitinib and side effects
Key secondary outcomes
Relationship between trough concentrations of sunitinib and efficacy
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
Patients with advanced renal cell carcinoma are treated with sunitinib for one year.
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 treated with sunitinib
2. Keeping major organ function
3. Taking agreement by document regarding participation for this clinical study
Key exclusion criteria
1. Patients with serious illness in kidney, liver, heart, or hematogenous function
2. Disqualified by a medical doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Nishimura |
Organization
Osaka International Cancer Institute
Division name
Department of Urology
Zip code
Address
3-1-69 Otemae, Chio-ku, Osaka, Japan
TEL
06-6945-1181
nisimura-ka2@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Nakayama |
Organization
Osaka International Cancer Institute
Division name
Department of Urology
Zip code
Address
3-1-69 Otemae, Chio-ku, Osaka, Japan
TEL
06-6945-1181
Homepage URL
nakayama-ma@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Urology, Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Osaka International Cancer Institute
Organization
Division
Category of Funding Organization
Self funding
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
大阪国際がんセンター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017073
