UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046970 |
|---|---|
| Receipt number | R000053258 |
| Scientific Title | An observational study to investigate the safety and efficacy of niraparib for Japanese patients with recurrent ovarian cancer: maintenance therapy for platinum-sensitive recurrent treatment and monotherapy for late-line treatment |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2024/02/27 18:14:23 |
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Basic information
Public title
An observational study to investigate the safety and efficacy of niraparib for Japanese patients with recurrent ovarian cancer: maintenance therapy for platinum-sensitive recurrent treatment and monotherapy for late-line treatment
Acronym
JGOG3031
Scientific Title
An observational study to investigate the safety and efficacy of niraparib for Japanese patients with recurrent ovarian cancer: maintenance therapy for platinum-sensitive recurrent treatment and monotherapy for late-line treatment
Scientific Title:Acronym
JGOG3031
Region
| Japan |
Condition
Condition
Ovarian cancer, fallopian tube cancer, primary peritoneal cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To confirm the safety, efficacy, and treatment details of niraparib therapy in the recurrent treatment of ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of adverse events
Key secondary outcomes
Progression-free survival (PFS) and PFS rate
Response rate in patients with residual disease (ORR)
Overall survival (OS)
Relationship to subsequent therapy, platinum-free interval
Incidence of secondary cancer
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Cohort 1
1.Patients with recurrent ovarian cancer with complete or partial response by the platinum-based combination chemotherapy
2.Patients who started niraparib maintenance therapy after December 2020
3.Japanese female patients aged =>18 years at the time of niraparib administration
Cohort 2
1.Patients with homologous recombination deficiency (HRD)-positive tumors sensitive to their last platinum-based chemotherapy who had received there or more anticancer therapy regimens
2.Japanese female patients aged =>18 years at the time of niraparib administration
Key exclusion criteria
1.Patients with active double cancer
2.Patients judged by the investigator to be inappropriate for participation in this study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Satoe |
| Middle name | |
| Last name | Fujiwara |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Obstetrics and Gynecology
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka, JAPAN
TEL
072-683-1221
satoe.fujiwara@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Satoe |
| Middle name | |
| Last name | Fujiwara |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Obstetrics and Gynecology
Zip code
569-8686
Address
2-7, Daigakumachi, Takatsuki, Osaka, JAPAN
TEL
072-683-1221
Homepage URL
http://jgog.gr.jp/
satoe.fujiwara@ompu.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
Japanese Gynecologic Oncology Group
Address
4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, JAPAN
Tel
03-5206-1982
info@jgog.gr.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
| 2022 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 06 | Month | 30 | Day |
Other
Other related information
Patients background, adverse events and prognosis in patients with recurrent ovarian cancer (including fallopian tube or primary peritoneal cancer) who received niraparib therapy
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053258
