UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043039 |
|---|---|
| Receipt number | R000049134 |
| Scientific Title | A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study) |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2022/01/19 09:08:45 |
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Basic information
Public title
A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Acronym
A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Scientific Title
A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Scientific Title:Acronym
A Multicenter, Open-label, Uncontrolled Phase II study of ONO-4538 [immune-checkpoint inhibitor] for cutaneous angiosarcoma ( Angio Check Study)
Region
| Japan |
Condition
Condition
Cutaneous angiosarcoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Multicenter study to evaluate the efficacy and safety of ONO-4538 in the treatment of advanced/recurrent cutaneous angiosarcoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Disease control rate, overall survival, progression free survival, time to response, duration of response
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
ONO-4538(Nivolumab) 480mgQ4w
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
Patients who have been confirmed by histology or cytology to be cutaneous angiosarcoma and cannot be cured by surgery and radiation therapy
Patients who have received prior chemotherapy with paclitaxel, which is the standard treatment for the target disease
Key exclusion criteria
Patients with a current history of autoimmune disease or past history of chronic or recurrent autoimmune disease.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Fujisawa |
Organization
University of Tsukuba
Division name
Dermatology
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3128
fujisan@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Hashimoto |
Organization
University of Tsukuba
Division name
T-CReDO
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
029-853-3326
Homepage URL
koichi.hashimoto@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ono pharmaceutical
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
University of Tsukuba
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3326
kimizuka.hiroe.ga@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT2031200020
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | 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
23
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2022 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049134
