Ovarian CancerNIRAPARIBNCT06614790
Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.
An observational study of Ovarian Cancer, run by Pomeranian Medical University Szczecin at 12 sites in Poland.
Trial summary
The study is observational, not interventional. The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program, and who are currently being treated under the B.50 drug program, funded by the National Health Fund. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Niraparib 200/300 MG
- How many people
- 300 participants
- Where
- 12 sitesPoland
- Study dates
- 2 Sep 2024to 7 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who complete the Chemotherapy Treatment Period without progressive disease (CR, PR, NED) will start Maintenance Treatment with niraparib after Cycle 6 up to 12 weeks after completion of the chemotherapy. Prior to receiving oral maintenance treatment, patients must have a CBC that demonstrates adequate recovery from hematologic toxicity from chemotherapy: * Absolute neutrophil count ≥1,500 cells/μL * Platelet count ≥100,000 cells/μL * Hemoglobin ≥10 g/dl
Who may be able to join
- Patients must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
- Patients with a histologically confirmed diagnosis of nonmucinous high - grade epithelial ovarian cancer (serous, endometrial) that is stage III or IV according to the FIGO criteria.
- All patients with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo PDS (R0 or macroscopic disease), or those for whom NACT is planned.
- Patients with Stage III are eligible if they meet the following criteria:
- All FIGO III patients in spite of residual disease and cytoreductive surgery.
- All patients with inoperable Stage III disease.
Show all 16Show fewer
- All Stage III patients after NACT chemotherapy.
- FFPE tumor tissue sample must be available for molecular analysis.
- Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 72 hours prior to receiving the first dose of study treatment.
- Patients must be postmenopausal, free from menses for >1 year, surgically sterilized, or willing to use highly effective contraception to prevent pregnancy (see 0) or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 180 days after the last dose of study treatment.
- Serum creatinine ≤1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation
- Total bilirubin ≤1.5 × ULN or direct bilirubin ≤1.5 × ULN
- AST and ALT ≤2.5 × ULN unless liver metastases are present, in which case they must be ≤5 × ULN
- Patients must have an ECOG score of 0 or 1.
- Patients must have normal BP or adequately treated and controlled hypertension.
- Patients must be able to take oral medication.
Who cannot join
- Patient has mucinous, germ cell, transitional cell, or undifferentiated tumor.
- Patient has low-grade or Grade 1 epithelial ovarian cancer.
- Patient has a known condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment in the opinion of the Investigator.
- Patient is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Patient is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use, during niraparib treatment and for 30 days after receiving the final dose of study treatment).
- Patient has any known history or current diagnosis of MDS or AML.
- Hypersensitivity to the active substance or to any of the excipients including tartrazine.
- Hypertension-Participants have systolic BP >140 mmHg or diastolic BP >90 mmHg that has not been adequately treated or controlled.
- Patients with prior history of PRES.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Poland12 sites, 12 recruiting
- Recruiting
Oddział Onkologii Ginekologicznej Białostockiego Centrum Onkologii
Bialystok
Beata Maćkowiak-Matejczyk, dr n. med., +48 85 66 46 885, kancelaria@onkologia.bialystok.pl
- Not yet recruiting
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej Uniwersyteckie Centrum Kliniczne
Gdansk
Dariusz Wydra, Prof. Dr hab. n med.
- Not yet recruiting
III Klinika Radioterapii i Chemioterapii Narodowego Instytutu Onkologicznego w Gliwicach
Gliwice
Rafał Tarnowski, prof. dr hab. n. med.
- Not yet recruiting
Świętokrzyskie Centrum Onkologii
Kielce
Stanisław Góźdź, PROF. DR HAB. N. MED.
- Not yet recruiting
Klinika Ginekologii Onkologicznej Narodowego Instytutu Onkologicznego w Krakowie
Krakow
Rafał Blecharz, prof. dr hab. n. med.
- Not yet recruiting
I Katedra i Klinika Ginekologii Onkologicznej i Ginekologii Uniwersytetu Medycznego w Lublinie
Lublin
Rafał Tarkowski, Prof. Dr hab. n med
- Not yet recruiting
Opolskie Centrum Onkologii
Opole
Joanna Tomiczek-Szwiec, dr n. med.
- Not yet recruiting
Oddział Onkologii Klinicznej i Radioterapii, Siedleckie Centrum Onkologii
Siedlce
Lubomir Bodnar, dr hab. n. med.
- Not yet recruiting
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM
Szczecin
Kaja Michalczyk
- Not yet recruiting
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM
Szczecin
Anita Chudecka-Głaz, dr hab. n. med.
- Not yet recruiting
, Klinika Ginekologii Onkologicznej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie
Warsaw
Anna Dańska-Bidzińska, dr n. med.
- Not yet recruiting
Klinika Ginekologii Onkologicznej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie
Warsaw
Mariusz Bidziński, prof. dr hab. n. med.
About this study
Official title: Patient Outcomes and Safety of Niraparib as Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, Ovarian Cancer. The First Real-World Evidence Study From Poland.
The study is observational, not interventional. The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program, and who are currently being treated under the B.50 drug program, funded by the National Health Fund.
Only patients currently being treated in the B.50 program at 10 selected centers listed on this site may be included in the study.
Of course, any patient in Poland eligible for maintenance treatment with niraparib can receive the drug, regardless of participation in this RWE study.The treatment involves administering niraparib as maintenance therapy for 3 years after the completion of chemotherapy, provided that the patient has responded to systemic treatment (NED, CR, PR).
Read the detailed description
Although over the last 2 decades the surgical management of ovarian cancer has improved with more chemotherapy options are available, however 5-year survival rates have remained relatively stable at 25 to 40% (36) The proposed real-life observation study can deliver valuable real-world information about niraparib patient outcomes and safety complementing the results of the PRIMA and PRIME clinical trials. This will also include establishing the importance of KELIM as a predictor of maintenance therapy choices. The multicenter design of the study will allow collection of data from a relatively large and representative group of patients within the Polish Drug program B.50. To this time, no study has been published about niraparib patient outcomes and safety in Poland.
This study will also include evaluation of patient outcomes when initiating therapy up to 4, 8, 12 weeks after completion of platinum based chemotherapy.
The population of patients included in the study will come from two programs: EAP and B.50.
EAP is an early access program sponsored by GSK, which has been operating in Poland since 2021 Jan. The inclusion criteria for EAP contained the same measurable parameters as the B.50 drug program offers.
The B.50 drug program is a ministerial program guaranteeing the Polish patients with advanced ovarian cancer access to approved medicines like maintenance treatment with PARP inhibitors, including niraparib.
The B.50 and EAP inclusion criteria are in accordance with the study protocol.
Primary Objective
- Primary objectives will be to describe patient and disease characteristics for patients receiving niraparib treatment in Poland.
- To quantify PFS: the primary PFS analysis will be based upon the Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, Appendix 2. The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 1.1 criteria
- PFS measured from the time of the first dose of niraparib.
- Primary objectives will also estimate safety and tolerability of niraparib treatment in Poland. Strict monitoring of safety profile (e.g. blood test is performed every 7 days during first month of treatment and after each changing of dose, blood pressure is performed every 7 days within the first two months then every month within the first year).
Secondary Objectives
- OS (Overall Survival)
- Chemosensitivity based on KELIM as a surrogate marker for platinum sensitivity to assess for niraparib response as a standard procedure due to the B.50 drug program
- Evaluation of outcomes of including patients in therapy up to 4, 8, 12 weeks after completion of platinum-based chemotherapy
- TFST (Time to the First Subsequent Therapy)
- DCR (Disease Control Rate).
INVESTIGATIONAL PLAN
Overall Study Design Patients who complete the Chemotherapy Treatment Period without progressive disease (CR, PR, NED) will start Maintenance Treatment with niraparib after Cycle 6 up to 12 weeks after completion of the chemotherapy.
Prior to receiving oral maintenance treatment, patients must have a CBC that demonstrates adequate recovery from hematologic toxicity from chemotherapy:
- Absolute neutrophil count ≥1,500 cells/μL
- Platelet count ≥100,000 cells/μL
- Hemoglobin ≥10 g/dl
Number of Patients and Study Design We expect to enroll approximately 300 patients from about 10 sites. Treatment part of study.
Part I- looking retrospectively at the time period JAN 2021-MAR 2023. The retrospective data will include patients who are enrolled in niraparib treatment:
- under the EAP (started in JAN 2021, in continuation)
- under the B.50 drug program, which began in January 2022 Of note, the retrospective multi-center observational study will involve about 30 patients treated with niraparib in EAP (FIGO III R0 after PDS included) and patients who were treated with niraparib before starting RWE (about 120 pts) (JAN 2021- MAR 2023) by the drug program B.50 which has been started to adapt on 1st of Jan, 2022.
FIGO III PDS to R0 patients are included to this study. Part II- looking prospectively at the time period APR 2023 to DEC 2025. The prospective data will include patients who are enrolled in niraparib treatment under the B.50 drug program.
The prospective multi-center observational study will involve about 150 patients with ovarian cancer (OC) who have been treated in about 10 OC gyn- oncocenters in Poland (OCgoC) (APR 2023- DEC 2025).
Study follow up Part III- survival follow up after treatment part of study (from JAN 2026 - DEC 2026).
Chemotherapy Treatment Period Not covered by the study protocol.
Maintenance Treatment Period All the patients will be given a sequential number by the system. Additionally, each patient from the EAP will have individual number which was given to them. In the CRF there will be additional information that there is a patient in the EAP phase of the study. Patients who have responded to first-line chemotherapy (NED, CR, PR) and with recovery to baseline of any hematologic toxicities will enter the Maintenance Treatment Period. Oral niraparib will be dispensed to patients on Day 1 of every 28-day cycle beginning with Cycle 1 of the Maintenance Treatment Period for up to 3 years in the absence of PD, unacceptable toxicity, or patient withdrawal, or based on Investigator's decision.
The recommended dose is 200 mg per day (2 capsules). Patients with a baseline body weight of ≥77 kg and baseline platelet count of ≥150,000 cells/μL will take 3 capsules of 100 mg strength (300 mg/day) at each dose administration.
Dose modifications will not be based upon changes in the patient's actual body weight during their study participation.
The inclusion criteria, the way of monitoring, both in a prospective and a retrospective cohort, will be followed by the B.50 drug program criteria. For that reason CA125 measurements necessary for KELIM as well as RECIST data are available in both cohorts during the whole period of time.
Duration of Treatment Patients may continue niraparib treatment for up to 3 years according to the B.50 drug program.
- Conditions
- Ovarian Cancer
- Being tested
- Niraparib 200/300 MG
- Keywords
- maintenance treatment, iPARP, advanced ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib 200/300 MGDrug
We expect to enroll approximately 300 patients from about 10 sites. Treatment part of study.
Part I- looking retrospectively at the time period JAN 2021-MAR 2023. The retrospective data will include patients who are enrolled in niraparib treatment:
- under the EAP (started in JAN 2021, in continuation)
- under the B.50 drug program, which began in January 2022 Of note, the retrospective multi-center observational study will involve about 30 patients treated with niraparib in EAP (FIGO III R0 after PDS included) and patients who were treated with niraparib before starting RWE (about 120 pts) (JAN 2021- MAR 2023) by the drug program B.50 which has been started to adapt on 1st of Jan, 2022.
FIGO III PDS to R0 patients are included to this study. Part II- looking prospectively at the time period APR 2023 to DEC 2025. The prospective data will include patients who are enrolled in niraparib treatment under the B.50 drug program.
The prospective multi-center observational study will i
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced, high-grade ovarian cancer who respond on the first line therapy (NED, CR,PR) | Not described Receives: Drug: Niraparib 200/300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability.
Safety and tolerability of niraparib treatment in Poland. Strict monitoring of safety profile (e.g. blood test is performed every 7 days during first month of treatment and after each changing of dose, blood pressure is performed every 7 days within the first two months then every month within the first year).
Measured: 27 months
PFS measured from the time of the first dose of niraparib.
The primary PFS analysis will be based upon the Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, Appendix 2. The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 1.1 criteria. PFS is defined as the time from first dose of niraparib starting until objective tumor progression or death.
Measured: 48 months
Secondary outcomes (5)
Chemosensitivity based on KELIM.
Chemosensitivity based on KELIM as a surrogate marker for platinum sensitivity to assess for niraparib response as a standard procedure due to the B.50 drug program.I will be measured after the chemotherapy based on CA125 making during the first 100 days of treatment.
Measured: 100 days
OS (Overall Survival).
Overall survival is defined as the time from the start of therapy to the day of patient's death to any cause.
Measured: 48 months
PFS depending on starting niraparib therapy.
Evaluation of outcomes of including patients in therapy up to 4, 8, 12 weeks after completion of platinum-based chemotherapy
Measured: 48 months
DCR (Disease Control Rate).
Disease control rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response, and stable disease to the niraparib intervention.
Measured: 48 months
TFST (Time to the First Subsequent Therapy).
TFST is defined as the time from initiation of first-line chemotherapy until the start of subsequent therapy or death.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start2 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion7 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614790
- Sponsor's protocol ID
- NIRAPARIB
- Other IDs
- GSK
- Acronym
- NIRAPARIB
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Outcomes and Safety of Niraparib as Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, Ovarian Cancer. The First Real-World Evidence Study From Poland.
- ClinicalTrials.gov ID
- NCT06614790
- Acronym / sponsor ID
- NIRAPARIB / NIRAPARIB
- Conditions
- Ovarian Cancer
- Keywords
- maintenance treatment, iPARP, advanced ovarian cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 7 Jan 2026 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is observational, not interventional. The study will include patients with advanced ovarian cancer who have been treated in Poland based on a previous early access program, and who are currently being treated under the B.50 drug program, funded by the National Health Fund.
Only patients currently being treated in the B.50 program at 10 selected centers listed on this site may be included in the study.
Of course, any patient in Poland eligible for maintenance treatment with niraparib can receive the drug, regardless of participation in this RWE study.The treatment involves administering niraparib as maintenance therapy for 3 years after the completion of chemotherapy, provided that the patient has responded to systemic treatment (NED, CR, PR).
Detailed description
Although over the last 2 decades the surgical management of ovarian cancer has improved with more chemotherapy options are available, however 5-year survival rates have remained relatively stable at 25 to 40% (36) The proposed real-life observation study can deliver valuable real-world information about niraparib patient outcomes and safety complementing the results of the PRIMA and PRIME clinical trials. This will also include establishing the importance of KELIM as a predictor of maintenance therapy choices. The multicenter design of the study will allow collection of data from a relatively large and representative group of patients within the Polish Drug program B.50. To this time, no study has been published about niraparib patient outcomes and safety in Poland.
This study will also include evaluation of patient outcomes when initiating therapy up to 4, 8, 12 weeks after completion of platinum based chemotherapy.
The population of patients included in the study will come from two programs: EAP and B.50.
EAP is an early access program sponsored by GSK, which has been operating in Poland since 2021 Jan. The inclusion criteria for EAP contained the same measurable parameters as the B.50 drug program offers.
The B.50 drug program is a ministerial program guaranteeing the Polish patients with advanced ovarian cancer access to approved medicines like maintenance treatment with PARP inhibitors, including niraparib.
The B.50 and EAP inclusion criteria are in accordance with the study protocol.
Primary Objective
- Primary objectives will be to describe patient and disease characteristics for patients receiving niraparib treatment in Poland.
- To quantify PFS: the primary PFS analysis will be based upon the Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, Appendix 2. The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 1.1 criteria
- PFS measured from the time of the first dose of niraparib.
- Primary objectives will also estimate safety and tolerability of niraparib treatment in Poland. Strict monitoring of safety profile (e.g. blood test is performed every 7 days during first month of treatment and after each changing of dose, blood pressure is performed every 7 days within the first two months then every month within the first year).
Secondary Objectives
- OS (Overall Survival)
- Chemosensitivity based on KELIM as a surrogate marker for platinum sensitivity to assess for niraparib response as a standard procedure due to the B.50 drug program
- Evaluation of outcomes of including patients in therapy up to 4, 8, 12 weeks after completion of platinum-based chemotherapy
- TFST (Time to the First Subsequent Therapy)
- DCR (Disease Control Rate).
INVESTIGATIONAL PLAN
Overall Study Design Patients who complete the Chemotherapy Treatment Period without progressive disease (CR, PR, NED) will start Maintenance Treatment with niraparib after Cycle 6 up to 12 weeks after completion of the chemotherapy.
Prior to receiving oral maintenance treatment, patients must have a CBC that demonstrates adequate recovery from hematologic toxicity from chemotherapy:
- Absolute neutrophil count ≥1,500 cells/μL
- Platelet count ≥100,000 cells/μL
- Hemoglobin ≥10 g/dl
Number of Patients and Study Design We expect to enroll approximately 300 patients from about 10 sites. Treatment part of study.
Part I- looking retrospectively at the time period JAN 2021-MAR 2023. The retrospective data will include patients who are enrolled in niraparib treatment:
- under the EAP (started in JAN 2021, in continuation)
- under the B.50 drug program, which began in January 2022 Of note, the retrospective multi-center observational study will involve about 30 patients treated with niraparib in EAP (FIGO III R0 after PDS included) and patients who were treated with niraparib before starting RWE (about 120 pts) (JAN 2021- MAR 2023) by the drug program B.50 which has been started to adapt on 1st of Jan, 2022.
FIGO III PDS to R0 patients are included to this study. Part II- looking prospectively at the time period APR 2023 to DEC 2025. The prospective data will include patients who are enrolled in niraparib treatment under the B.50 drug program.
The prospective multi-center observational study will involve about 150 patients with ovarian cancer (OC) who have been treated in about 10 OC gyn- oncocenters in Poland (OCgoC) (APR 2023- DEC 2025).
Study follow up Part III- survival follow up after treatment part of study (from JAN 2026 - DEC 2026).
Chemotherapy Treatment Period Not covered by the study protocol.
Maintenance Treatment Period All the patients will be given a sequential number by the system. Additionally, each patient from the EAP will have individual number which was given to them. In the CRF there will be additional information that there is a patient in the EAP phase of the study. Patients who have responded to first-line chemotherapy (NED, CR, PR) and with recovery to baseline of any hematologic toxicities will enter the Maintenance Treatment Period. Oral niraparib will be dispensed to patients on Day 1 of every 28-day cycle beginning with Cycle 1 of the Maintenance Treatment Period for up to 3 years in the absence of PD, unacceptable toxicity, or patient withdrawal, or based on Investigator's decision.
The recommended dose is 200 mg per day (2 capsules). Patients with a baseline body weight of ≥77 kg and baseline platelet count of ≥150,000 cells/μL will take 3 capsules of 100 mg strength (300 mg/day) at each dose administration.
Dose modifications will not be based upon changes in the patient's actual body weight during their study participation.
The inclusion criteria, the way of monitoring, both in a prospective and a retrospective cohort, will be followed by the B.50 drug program criteria. For that reason CA125 measurements necessary for KELIM as well as RECIST data are available in both cohorts during the whole period of time.
Duration of Treatment Patients may continue niraparib treatment for up to 3 years according to the B.50 drug program.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced, high-grade ovarian cancer who respond on the first line therapy (NED, CR,PR) | – | Drug: Niraparib 200/300 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who complete the Chemotherapy Treatment Period without progressive disease (CR, PR, NED) will start Maintenance Treatment with niraparib after Cycle 6 up to 12 weeks after completion of the chemotherapy. Prior to receiving oral maintenance treatment, patients must have a CBC that demonstrates adequate recovery from hematologic toxicity from chemotherapy: * Absolute neutrophil count ≥1,500 cells/μL * Platelet count ≥100,000 cells/μL * Hemoglobin ≥10 g/dl
Key inclusion criteria (16 listed)
- Patients must be female, ≥18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
- Patients with a histologically confirmed diagnosis of nonmucinous high - grade epithelial ovarian cancer (serous, endometrial) that is stage III or IV according to the FIGO criteria.
- All patients with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo PDS (R0 or macroscopic disease), or those for whom NACT is planned.
- Patients with Stage III are eligible if they meet the following criteria:
- FFPE tumor tissue sample must be available for molecular analysis.
Key exclusion criteria (8 listed)
- Patient has mucinous, germ cell, transitional cell, or undifferentiated tumor.
- Patient has low-grade or Grade 1 epithelial ovarian cancer.
- Patient has a known condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment in the opinion of the Investigator.
- Patient is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Patient is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use, during niraparib treatment and for 30 days after receiving the final dose of study treatment).
- Patient has any known history or current diagnosis of MDS or AML.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraparib 200/300 MGWe expect to enroll approximately 300 patients from about 10 sites. Treatment part of study. Part I- looking retrospectively at the time period JAN 2021-MAR 2023. The retrospective data will include patients who are enrolled in niraparib treatment: * under the EAP (started in JAN 2021, in continuation) * under the B.50 drug program, which began in January 2022 Of note, the retrospective multi-center observational study will involve about 30 patients treated with niraparib in EAP (FIGO III R0 after PDS included) and patients who were treated with niraparib before starting RWE (about 120 pts) (JAN 2021- MAR 2023) by the drug program B.50 which has been started to adapt on 1st of Jan, 2022. FIGO III PDS to R0 patients are included to this study. Part II- looking prospectively at the time period APR 2023 to DEC 2025. The prospective data will include patients who are enrolled in niraparib treatment under the B.50 drug program. The prospective multi-center observational study will i | Drug | Patients with advanced, high-grade ovarian cancer who respond on the first line therapy (NED, CR,PR) |
Primary outcome
Safety and tolerability.
Time frame: 27 months
Safety and tolerability of niraparib treatment in Poland. Strict monitoring of safety profile (e.g. blood test is performed every 7 days during first month of treatment and after each changing of dose, blood pressure is performed every 7 days within the first two months then every month within the first year).
PFS measured from the time of the first dose of niraparib.
Time frame: 48 months
The primary PFS analysis will be based upon the Investigator's assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria, Appendix 2. The day considered as disease progression is the day of the CT examination on which progression was found according to RECIST 1.1 criteria. PFS is defined as the time from first dose of niraparib starting until objective tumor progression or death.
5 secondary outcomes
Chemosensitivity based on KELIM.
Time frame: 100 days
OS (Overall Survival).
Time frame: 48 months
PFS depending on starting niraparib therapy.
Time frame: 48 months
DCR (Disease Control Rate).
Time frame: 48 months
TFST (Time to the First Subsequent Therapy).
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oddział Onkologii Ginekologicznej Białostockiego Centrum Onkologii
Bialystok, Poland
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Pomeranian Medical University Szczecin at 12 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability. (time frame: 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.