UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052336 |
|---|---|
| Receipt number | R000059652 |
| Scientific Title | Libtayo Intravenous Infusion 350 mg Special Drug-use Results Survey for Cervical Cancer |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/07/23 18:57:12 |
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Basic information
Public title
Libtayo Intravenous Infusion 350 mg Special Drug-use Results Survey for Cervical Cancer
Acronym
Libtayo Intravenous Infusion 350 mg Special Drug-use Results Survey for Cervical Cancer
Scientific Title
Libtayo Intravenous Infusion 350 mg Special Drug-use Results Survey for Cervical Cancer
Scientific Title:Acronym
Libtayo Intravenous Infusion 350 mg Special Drug-use Results Survey for Cervical Cancer
Region
| Japan |
Condition
Condition
Advanced or recurrent cervical cancer with disease progression after chemotherapy
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This surveillance will be conducted in order to collect information on the safety of cemiplimab under actual use conditions in patients with advanced or recurrent cervical cancer with disease progression after chemotherapy and to understand the following topics.
(1) The frequency and severity of the safety specifications.
(2) Factors that may affect the safety of cemiplimab.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence proportion of adverse drug reactions to safety specifications during the observation period
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 newly treated with cemiplimab according to the dosage and administration of the drug for the approved indication of advanced or recurrent cervical cancer with disease progression after chemotherapy in Japan.
Key exclusion criteria
NA
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Saito |
Organization
Global Patient Safety
Division name
Global Patient Safety
Zip code
100-0005
Address
Tekko building 4F, 1-8-2 Marunouchi, Chiyoda-ku, Tokyo
TEL
09087282970
kazuhiro.saito@regeneron.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Emoto |
Organization
Global Patient Safety
Division name
Global Patient Safety
Zip code
100-0005
Address
Tekko building 4F, 1-8-2 Marunouchi, Chiyoda-ku, Tokyo
TEL
09087250671
Homepage URL
ayumi.emoto@regeneron.com
Sponsor or person
Institute
Regeneron Japan KK
Institute
Department
Personal name
Funding Source
Organization
Regeneron Japan KK
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
Japan Conference of Clinical Research
Address
1-13-23, Minamiikebukuro, Toshima-ku, Tokyo
Tel
0368687022
jccr-info@jccr.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Significant difference test to identify patient background factors for occurrence of adverse reactions of safety specifications.
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059652
