UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026520 |
|---|---|
| Receipt number | R000030378 |
| Scientific Title | The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer |
| Date of disclosure of the study information | 2017/03/15 |
| Last modified on | 2020/03/16 15:17:19 |
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Basic information
Public title
The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Acronym
The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Scientific Title
The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Scientific Title:Acronym
The efficacy and safety of enzalutamide in patients with non-muscle invasive bladder cancer
Region
| Japan |
Condition
Condition
non-muscle invasive bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-tumor effect of enzalutamide against non-muscle invasive bladder cancer and to evaluate the safety of enzalutamide in patients with non-muscle invasive bladder cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Tumor shrinkage 4 weeks after administration
Key secondary outcomes
safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
enzalutamide administration for four weeks
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
Key inclusion criteria
pathologically diagnosed non-muscle invasive bladder cancer patients
Key exclusion criteria
history of androgen deprivation therapy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Kojima |
Organization
Tsukuba University Hospital
Division name
Urology
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3223
tkojima@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kawahara |
Organization
Tsukuba University Hospital
Division name
Urology
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3223
Homepage URL
tkawahar99@gmail.com
Sponsor or person
Institute
Urology department of Tsukuba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University Hospital
Address
2-1-1, Amakubo,Tsukuba city
Tel
029-853-3914
rinshokenkyu@un.tsukuba.ac.jp
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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030378
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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