UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059331 |
|---|---|
| Receipt number | R000066915 |
| Scientific Title | Special drug use-results survey on BALVERSA |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 12:12:06 |
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Basic information
Public title
Special drug use-results survey on BALVERSA
Acronym
BAL1L
Scientific Title
Special drug use-results survey on BALVERSA
Scientific Title:Acronym
BAL1L
Region
| Japan |
Condition
Condition
unresectable urothelial carcinoma with FGFR3 gene mutations or fusion genes that has progressed after cancer chemotherapy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the occurrence of eye disorders (excluding retinal detachment and corneal disorder) and severe skin disorders (excluding hand and foot syndrome) in patients with radically unresectable urothelial carcinoma with FGFR3 gene mutation or fusion gene who have progressed after cancer chemotherapy (Hereinafter referred to as this drug) under actual use conditions.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1_Occurrence of adverse reactions included in safety specifications
2_Occurrence status of adverse reactions of eye disorder, skin disorder, and skin disorder (excluding hand and foot syndrome)
3_Factors that may affect adverse reactions in the safety specifications (e.g., occurrence by patient background) *
4_Factors that may affect adverse reactions of eye disorders, skin disorders, and skin disorders (excluding hand and foot syndrome) (e.g., occurrence status by patient background) *
*: Tabulation and analysis will be performed when there are more than 5 cases.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable urothelial carcinoma with FGFR3 gene mutation or fusion that has progressed after cancer chemotherapy who have received BALVERSA for the first time will be included.
Key exclusion criteria
Patients with a history of the use of BALVERSA
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Koyama |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Delivery Unit
Zip code
101-0065
Address
5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
TEL
080-1288-9551
tkoyama4@its.jnj.com
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Harada |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Delivery Unit
Zip code
101-0065
Address
5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
TEL
080-1288-9551
Homepage URL
sharada8@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Janssen Pharmaceutical K.K.
Address
Janssen Pharmaceutical K.K.
Tel
080-1288-9551
sharada8@its.jnj.com
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
| 2025 | Year | 10 | Month | 08 | 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
| 2024 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066915
