The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer
Conditions: Epithelial Ovarian Cancer
Sponsor: Asan Medical Center

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The Real world Efficacy and saFety of nIrapaRib in Korean women with priMary and 
recurrent epithelial ovarian cancer  
(REFIRM) 
 
 
 
 
 
 
Protocol 
NCT number : NCT06086665 
 
 
Seoul Asan Medical Center 
Jeong-Yeol Park 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SUMMARY 
 
Study Title  
The real world efficacy and safety of niraparib in Korean women with 
primary and recurrent epithelial ovarian cancer(REFIRM) 
Principal 
Investigator 
Jeong-Yeol Park, MD, PhD 
Professor, Department of Obstetrics and Gynecology, University of Ulsan 
College of Medicine, Asan Medical Center, Seoul, Republic of Korea 
Study funding 
institution 
Takeda Pharmaceuticals Korea co., Ltd 
 
Objectives 
 To evaluate the efficacy and safety of niraparib in Korean women with 
primary and recurrent epithelial ovarian cancer who underwent niraparib 
maintenance therapy 
 To evaluate the efficacy and safety of salvage niraparib therapy in Korean 
women with heavily pretreated epithelial ovarian cancer. 
Study  Design 
Multicenter, retrospective cohort and chart-review  study 
Duration of study 
 2023.04.01 – 2024.06.30 
Study drug 
Niraparib 
Study subjects  
(study drug, and 
etc )  
 
• Study population: Patients with epithelial ovarian cancer of any 
histological type   
 
 
Cohorts 
• Observation cohort (Cohort A) : All patients who did not receive any kind 
of maintenance therapy for primary epithelial ovarian cancer from Dec 
2019 to Oct 2022  
• Treatment cohort (Cohort B-D) : Epithelial ovarian cancer patients who 
treated with niraparib from Dec 2019 to Oct 2022  
 
Cohort B: All patients who received or who are receiving 
niraparib maintenance therapy for primary epithelial ovarian 
cancer in 1st line setting.  
 
Cohort C: All patients who received or who are receiving 
niraparib maintenance therapy for recurrent epithelial ovarian 
cancer in 2nd or 3rd line setting.  
 
Cohort D: All patients who received or who are receiving 
salvage niraparib therapy for recurrent epithelial ovarian 
cancer in 4th line or more line setting.  
Vulnerable subjects 
Not applicable 
Study methods 
This study is a multicenter, retrospective cohort and comparative study in 
Korea.  

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Clinical information will be collected and analyzed through medical records 
of 12 centers.  
Efficacy evaluation 
Progression-free survival analysis 
- 
Obtain a survival curve using the Kaplan-Meir method, and 
compare the survival rates between groups using the log-rank test. 
Multivariate survival analysis is performed using Cox's proportional 
hazard model. 
Safety evaluation 
The fraction that adverse events occurred, the fraction that dose 
modification occurred, the fraction that dose delay occurred, and the fraction 
that treatment discontinuation occurred will be calculated, respectively. The 
comparison of the fractions between groups will be done by the Chi-square 
test or the Fisher exact test according to the fraction and sample size of 
data. Comparison of means between groups will be done by Student t test 
or Mann-Whitney U test. Also Student T test or Mann Whitney U test will be 
used to compare the means between groups according to the fraction and 
sample size of data. 
Expected outcomes 
Throughout this study, we expect to confirm the real world efficacy and 
safety of Niraparib in maintenance and salvage therapy for Korean ovarian 
cancer patients. 
In addition, this study is a multicenter study in Korea, so we aim to obtain 
clinical information of 700 primary and recurrent epithelial ovarian cancer 
patients. This is a first large size of Korea study for ovarian cancer patients. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Protocol 
 
1. Title 
The real world efficacy and safety of niraparib in Korean women with primary and recurrent 
epithelial ovarian cancer(REFIRM) 
 
2. Name of sites 
 
Total 12 sitesAsan Medical Center, Seoul (Jeong-yeol* Park)  
 
Samsung Medical Center (Byunggi Kim*) 
 
Seoul National University Hospital (Kim Jae-won*) 
 
National Cancer Center (Myong Cheol Lim) 
 
Severance Hospital (Lee Jeong-yoon) 
 
Keimyung University Hospital (Shin Sojin) 
 
Kyungpook national university Chilgok Hospital (Dae Gy Hong) 
 
Seoul St. Mary's Hospital (Keun Ho Lee) 
 
Pusan National University Yangsan Hospital.(Yong Jung Song) 
 
Inje University haeundae paik hospital (Yong Il Ji) 
 
Pusan National University hospital (Ki Hyung Kim) 
 
Inje University Busan Paik Hospital (Dae Hoon Jeong) 
 
3. Principal investigator and co-investigators 
1) Principal investigator 
Jeong-Yeol Park, MD, PhD 
Professor, Department of Obstetrics and Gynecology, University of Ulsan College of 
Medicine, Asan Medical Center, Seoul, Republic of Korea 
e-mail : catgut1-0@hanamil.nat / obgyjypark@amc.seoul.kr / obgyjypark@gmail.com  
Tel : +82-2-3010-3646 
 
2) Investigators  
• 
Samsung Medical Center (Byunggi Kim*) 
• 
Seoul National University Hospital (Kim Jae-won*) 

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• 
National Cancer Center (Myong Cheol Lim) 
• 
Severance Hospital (Lee Jeong-yoon) 
• 
Keimyung University Hospital (Shin Sojin) 
• 
Kyungpook national university Chilgok Hospital (Dae Gy Hong) 
• 
Seoul St. Mary's Hospital (Keun Ho Lee) 
• 
Pusan National University Yangsan Hospital.(Yong Jung Song) 
• 
Inje University haeundae paik hospital (Yong Il Ji) 
• 
Pusan National University hospital (Ki Hyung Kim) 
• 
Inje University Busan Paik Hospital (Dae Hoon Jeong) 
 
3) Main study researcher 
Dr. Ok-Ju Kang 
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, 
Asan Medical Center, Seoul, Republic of Korea 
lalala1301@gmail.com 
02-3010-0011 
 
4. Name and location of study funding institution  
Takeda Pharmaceuticals Korea co., Ltd 
37F, Lotte World Tower, Olympic-Ro 300, Songpa-gu, Seoul 0551, Korea (05551) 
 
5. Duration of study 
 2023.04.01 – 2024.06.30 
6. Target disease 
Primary and recurrent epithelial ovarian cancer  
 
7. Study background and rationale 
1) Background 
It has been three years since niraparib was introduced into Korea, and about 600 Korean 
patients with epithelial ovarian cancer have been treated with this drug. The efficacy and 
safety of niraparib in primary and recurrent epithelial ovarian cancer were well 
demonstrated in the NOVA trial and the PRIMA trial, and the efficacy and safety of 
niraparib in heavily pretreated epithelial ovarian cancer patients were confirmed in the -
QUADRA trial. However, safety and efficacy data in Korean women are still scanty. The 

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purpose of this study was to evaluate the safety and efficacy of niraparib in Korean women 
with primary and recurrent epithelial ovarian cancer.  
 
2) Study rationale 
The pivotal clinical trials of niraparib in primary and recurrent epithelial ovarian cancer, 
PRIMA, NOVA, and -QUADRA trials, did not include Korean women with epithelial ovarian 
cancer. Therefore, the efficacy and safety of niraparib in Korean women with epithelial 
ovarian cancer have not yet been properly evaluated or reported. However, the use of 
niraparib in Korean women with epithelial ovarian cancer is rapidly increasing, and a lot 
of experience in drug use is accumulating. To confirm that the efficacy and safety of 
niraparib used in the actual treatment process in Korean women are similar to the clinical 
trial results, and to prepare a plan to maximize niraparib compliance by effectively 
controlling the dosing schedule change and side effects in Korean women, it is very 
important to analyze the clinical results of Korean women with epithelial ovarian cancer 
using niraparib. 
 
8. Study method 
1) Inclusion and Exclusion criteria 
 Inclusion criteria:  
• 
Patients were diagnosed with all histologic type of epithelial ovarian cancer 
• 
Observation cohort (Cohort A): All patients who did not receive any kind of maintenance 
therapy for primary epithelial ovarian cancer from Dec 2019 to Oct 2022 
• 
Treatment cohort: Epithelial ovarian cancer patients who treated with niraparib as 
maintenance treatment in any line from Dec 2019 to Oct 2022 
- 
Cohort B: All patients who received or who are receiving niraparib maintenance 
therapy for primary epithelial ovarian cancer in 1st line setting 
- 
Cohort C: All patients who received or who are receiving niraparib maintenance 
therapy for recurrent epithelial ovarian cancer in 2nd or 3rd line setting  
- 
Cohort D: All patients who received or who are receiving salvage niraparib therapy for 
recurrent epithelial ovarian cancer in 4th line or more line setting 
 
 Exclusion criteria: 
• 
Borderline ovarian tumor 
• 
Malignant ovarian germ cell tumor 
• 
Malignant sex-cord stroma tumor 
• 
Other malignancy within 5 years of diagnosis of epithelial ovarian cancer excluding 
carcinoma in situ of uterine cervix, endometrium, bladder, stomach, papillary thyroid 
cancer, and non-melanoma skin cancer 
 
2) Total # of Subjects :  

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 
Sample size of target population from real practice is not known a priori. All eligible patient 
records available in sites meeting the inclusion criteria will be analysed. 
 
Estimated numbers of patients in each cohort are below.  
- 
Observation cohort/Cohort A : approximately 350 patients 
- 
Cohort B: approximately 350 patients  
- 
Cohort C: approximately 150 patients  
- 
Cohort D: approximately 15 patients  
 
 
Total target number of subjects in Asan medical center: approximately 200 patients 
 
3) Sample size determination 
Considering the nature of retrospective study, sample size cannot be calculated based on 
reference. We have a plan to collect the patient data as much as possible from multi-centers.  
 
4) Informed Consent  
As this is a retrospective cohort study using medical records, we plan to get approval on 
consent exemption. 
 
5) Study process 
(1) IRB approval from each site 
(2) In each site, investigator and study team will investigate the medical records from patients 
diagnosed with primary and recurrent epithelial ovarian cancers based on 
inclusion/exclusion criteria and collect the clinical information and result of laboratory, 
pathology, imaging and treatment records including response, retrospectively.  
(3) (Expected period of medical records: 1st December 2019 – 31st October 2022) 
(4) Each site will assign a subject number for each patient. Patient number will consist with 
site number and number of patient’s order. Site number will be used with abbreviation of 
hospital name in English.  Subject sequence numbers are assigned sequentially, 
starting with 001. 
(5) Each site will secure the files related to the subject number and information 
confidentially. 
(6) Each site will transmit the data to Seoul Asan Medical Center.  
(7) Asan medical center will analyze data.  
Our data will not be exported outside the AMC, instead AMC will collect and analyze the data while 
other institutions will only be involved in data collection. Takeda Product will only use statistical 
results from the data. Data collection  
Clinical demographics of patients will be collected, which include biochemical test results, 

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histologic results, imaging test results, treatment, recurrence status, and survival/death follow-up. 
All data will be collected based on medical cords  
(1) Basic information 
Age at diagnosis, date at diagnosis, height, body weight, BMI 
(2) Stage and pathological test  
Primary/recurrent, tissue type, stage, pelvic lamp node metastasis, aortic lymph node 
metastasis  
(3) Genetic test (if implemented) 
Germline BRCA1/2 mutation status 
Somatic BRCA1/2 mutation status 
(4) Treatment history  
Advanced chemotherapy, previous history of chemotherapy, date of 1st cytoreductive 
surgery, blood loss during surgery, residual tumor status, CA-125 before treatment, 
residual tumor status after treatment, total number of chemotherapy cycles, duration of 
treatment, date of discontinuation, reason for discontinuation 
(5) Recurrence history  
Date of recurrence (confirmed with image-based RECIST version1.1) 
age at recurrence, performance status, CA-125, ascites status, location and size of 
recurrent lesions 
(6) Treatment with niraparib as maintenance treatment  
Type of anti-cancer drug, number of chemotherapy cycles, initial dose of Niraparib, dose 
modification schedule, number of days of administration, date of discontinuation, reason 
for discontinuation, image is discontinued due to disease progression   
(7) Treatment with niraparib as salvage therapy  
Initial dose of Niraparib, dose modification schedule, number of days of administration, 
date of discontinuation, reason for discontinuation 
(8) Follow-up  
Survival/death, last visit date, date of death 
patients’ deaths will be collected through medical records  
6) Management and Reporting of adverse events  
(1) Definitions 
1.1.  Adverse Events 
An adverse event (AE) is any untoward medical occurrence in a subject 
administered a medicinal product and which does not necessarily have to have a 
causal relationship with this treatment. An AE can therefore be any unfavorable 
and unintended sign (including an abnormal laboratory finding), symptom, a new 
disease or worsening in severity or frequency of a concomitant disease, temporally 

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associated with the use of a medicinal product, whether or not the event is 
considered causally related to the use of the product. 
 
Although abnormal laboratory values are typically not considered AEs, the following 
considerations may result in an abnormal laboratory value being considered an AE: 
• 
A laboratory test result that meets the criteria for an SAE 
• 
A laboratory test result that requires the subject/patient to receive 
specific corrective therapy 
• 
A laboratory abnormality that leads to discontinuation of therapy 
• 
A laboratory abnormality that the healthcare provider considers to be clinically 
significant 
 
1.2. Serious Adverse Events 
 
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: 
• 
Results in death. Note that death is an outcome of an event. The event(s) 
causing death should be recorded. 
• 
In the view of the Healthcare provider, places the subject/patient at 
immediate risk of death (a life-threatening event); however, this does not 
include an event that, had it occurred in a more severe form, might have 
caused death 
• 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• 
Results in persistent or significant disability/incapacity 
• 
Results in a congenital anomaly/birth defect 
• 
An SAE may also be any other medically important event that, in the opinion of 
the Healthcare provider, may jeopardize the subject/patient or may require 
intervention to prevent one of the other outcomes listed in the definition above. 
(Examples of such medical events include allergic bronchospasm requiring 
intensive treatment in an emergency room or convulsions occurring at home 
that do not require an inpatient hospitalization). 
 
1.3. Adverse Drug Reactions 
An adverse drug reaction (ADR) is an AE for which there is at least a reasonable 
suspicion of a causal relationship between an AE and a suspected medicinal 
product. 
 
1.4. Product Quality Complaints 
A Product Quality Complaint is any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, strength, 
purity, effectiveness, or performance of a product or device and combination 
product after it is released for distribution. 
 

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1.5. Special Situation Reports 
A Special Situation Report (SSR) includes any of the following events: 
• 
Pregnancy: Any case in which a pregnancy patient is exposed to a Takeda 
Product or in which a female patient or female partner of a male patient becomes 
pregnant following treatment with Takeda Product. Exposure is considered either 
through maternal exposure or via semen following paternal exposure. 
• 
Breastfeeding: Infant exposure from breast milk 
• 
Overdose: All information of any accidental or intentional overdose 
• 
Drug abuse, misuse, or medication error: All information on medicinal product 
abuse, misuse or medication error (potential or actual) 
• 
Suspected transmission of an infectious agent: Suspected (in the sense of 
confirmed or potential) transmission of an infectious agent by a medicinal product. 
• 
Lack of efficacy of Takeda Product 
• 
Accidental/Occupational exposure 
• 
Use outside the terms of the marketing authorization, also known as “off-label” 
• 
Use of falsified medicinal product 
• 
Use of counterfeit medicinal product 
• 
Drug-drug interactions and drug-food interactions 
• 
Inadvertent or accidental exposure with or without an AE 
• 
Unintended benefit  
 
An SSR should be reported even if there is no associated AE. 
 
1.6 Relationship of an AE to studied drug(s) 
• 
Related (Yes): An AE that follows a reasonable temporal sequence from administration of 
the medication, vaccine or device (including the course after withdrawal of the medication), 
and for which a causal relationship is at least a reasonable possibility, i.e., the relationship 
cannot be ruled out, although factors other than the medication, vaccine or device, such as 
underlying diseases, complications, concomitant drugs and concurrent treatments, may 
also have contributed. 
• 
Not related (No): An AE that does not follow a reasonable temporal sequence from 
administration of the medication, vaccine or device and/or that can reasonably be 
explained by other factors, such as underlying disease, complications, concomitant drugs 
and concurrent treatments. 
The assessment of the relationship of an AE to the studied drug(s) should be based on 
the Investigator’s consideration of all available information about the event, including 
temporal relationship to drug administration, recognized association with drug 
product/class, pharmacological plausibility, and alternative etiology (e.g. underlying 
illness, concurrent conditions, concomitant treatments). 
 

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(2) Collection and notifying of Adverse Events, Special Situation Reports and Product Quality 
Complaints to Takeda Pharmacovigilance 
• SAEs, AEs, ADRs, SSRs and PQCs in the healthcare record or other applicable 
source data that are part of the study objectives or endpoints. Events/complaints 
which are part of the study objectives or endpoints will be systematically identified 
and collected from healthcare records or other applicable source records and 
summarized as part of any interim analysis and in the final study report. 
Such events do not need to be notified as individual reports to Takeda  
                 
Pharmacovigilance. 
 
• SAEs, AEs, SSRs and PQCs in the healthcare records or other applicable source 
data that are not part of the study objectives and endpoints. 
Events/complaints which are not part of the study objectives and endpoints will not be 
abstracted or collected from medical records or other applicable source records. 
 
(3) Reporting of adverse drug reactions and special situation reports to regulatory agencies.  
• The Institution/Investigator is solely responsible for reporting all Adverse Events and 
Serious Adverse Events to regulatory authorities, investigators, IRBs or IECs and 
Takeda, as applicable, in accordance with national regulations in the countries where 
the study is conducted. 
 
 
9. Data and Statistical analysis method  
1) Progression-free survival  
Obtain a survival curve using the Kaplan-Meir method in all cohorts, and compare the survival 
rates between cohort A vs cohort B in total patients, BRCA WT and mutation patients using 
the log-rank test. Multivariate survival analysis will be performed using Cox's proportional 
hazard model. 
2) Safety analysis 
The fraction that adverse events occurred, the fraction that dose modification occurred, the fraction 
that dose delay occurred, and the fraction that treatment discontinuation occurred were calculated, 
respectively. The comparison of the fractions between groups will be done by the Chi-square test 
or the Fisher exact test. Comparison of means between groups will be done by Student t test or 
Mann-Whitney U test. 
- The data for SAEs, AEs with grade>=3, and AEs with fatal outcome will be analyzed 
-The important risks (eg, hematological toxicities, second primary malignancies will be particularly 
evaluated/analyzed 
3) Overall survival analysis  
Obtain a survival curve using the Kaplan-Meir method in all cohorts, and compare the survival 
rates between cohort A vs cohort B in total patients, BRCA WT and mutation patients using the 
log-rank test. Multivariate survival analysis is performed using Cox's proportional hazard model. 
 Statistical analysis will be performed using IBM SPSS version 21, and p < 0.05 (two-sided test) 
will be recognized as a statistically significant difference. 

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 
In Multivariate survival analysis, we will consider the factors including germline BRCA 
mutational status, tumor HRD status, previous neoadjuvant chemotherapy, and response 
to first-line platinum chemotherapy, residual disease status following cytoreductive 
surgery, stage at diagnosis, and whether a patient received neoadjuvant chemo with IDS 
or PDS followed by adjuvant chemo, if possible. 
 
10. Expected outcomes  
Throughout this study, we expect to confirm the real world efficacy and safety of Niraparib in 
maintenance and salvage therapy for Korean ovarian cancer patients. 
In addition, this study is a multicenter study in Korea, so we aim to obtain clinical information of 
700 primary and recurrent epithelial ovarian cancer patients. This is a first large size of Korea 
study for ovarian cancer patients. 
 
11. Subject Data and Safety Protection 
1) Ethical principles of the study  
This study will be adopted by the principles of the 18th World Medical Assembly (the declaration 
of Helsinki) and conducted in accordance with Good Clinical Practice (GCP), International 
Conference on Harmonization (ICH) guidelines, and the applicable country’s regulatory 
requirements and laws. In addition, this study will be initiated after IRB approval.  
2) Personal information protection  
The patients’ medical number and pathology number will be stored as a separate file under the 
responsibility of Principal investigator, and will be coded and managed so that personal 
identification cannot be verified through research data.   
All data will be stored with a password protected file and stored in a locked laboratory. Only a 
single computer will be used for data collection and analysis, and this hardware will be under 
surveillance controlled by institution’s web security program.  
Only the registered research personnel are allowed to view the data, and these files will not be 
open to anyone other than listed in our study documents 
 According to article 15 of the Bioethics and Safety act, medical records and data related to the 
research will be kept for 3 years from the time the study is completed. Documents including  
personal information will be disposed after storge period in accordance with article 16 of the 
Enforcement Decree of the Personal Information Protection Act. 
 
12. Archiving of study documents and Disposal 
The estimated research period is around 1 year from the date of IRB approval. The collected data 
of subjects will be stored as separate file under the responsibility of Principal investigator, coded, 
managed so that personal identification cannot be verified through research data, stored and used, 
and research data will be stored with password and in a locked laboratory. 
According to article 15 of the Bioethics and Safety act, records related to the research will be kept 
for 3 years from the time the study is completed. Privacy information(ex. E-CRF, any documented 

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information about the patients) will be destroyed thereafter according to the study site destruction 
process in accordance with article 16 of the Enforcement Decree of the Personal Information 
Protection Act. The instructions about data destruction will be stored as a file signed by both the 
principal- and co-investigators. 
 
13. Preservation and Discarding of Human Materials  
Not applicable 
 
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