Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.

NCT06614790 | Recruiting DMC

• 2 other identifiers: NIRAPARIBGSK
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 12

Brief 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. 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).

Conditions

Ovarian Cancer

Keywords

maintenance treatment; iPARP; advanced ovarian cancer

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  48 months

Secondary Outcomes (5)

• Chemosensitivity based on KELIM.

  100 days

• OS (Overall Survival).

  48 months

• PFS depending on starting niraparib therapy.

  48 months

• DCR (Disease Control Rate).

  48 months

• TFST (Time to the First Subsequent Therapy).

  48 months

Study Arms (1)

Patients with advanced, high-grade ovarian cancer who respond on the first line therapy (NED, CR,PR)

Drug: Niraparib 200/300 MG

Interventions

Niraparib 200/300 MG DRUG

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

Patients with advanced, high-grade ovarian cancer who respond on the first line therapy (NED, CR,PR)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (12)

Oddział Onkologii Ginekologicznej Białostockiego Centrum Onkologii

Bialystok, Poland

RECRUITING

Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

NOT YET RECRUITING

III Klinika Radioterapii i Chemioterapii Narodowego Instytutu Onkologicznego w Gliwicach

Gliwice, Poland

NOT YET RECRUITING

Świętokrzyskie Centrum Onkologii

Kielce, Poland

NOT YET RECRUITING

Klinika Ginekologii Onkologicznej Narodowego Instytutu Onkologicznego w Krakowie

Krakow, Poland

NOT YET RECRUITING

I Katedra i Klinika Ginekologii Onkologicznej i Ginekologii Uniwersytetu Medycznego w Lublinie

Lublin, Poland

NOT YET RECRUITING

Opolskie Centrum Onkologii

Opole, Poland

NOT YET RECRUITING

Oddział Onkologii Klinicznej i Radioterapii, Siedleckie Centrum Onkologii

Siedlce, Poland

NOT YET RECRUITING

Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM

Szczecin, Poland

NOT YET RECRUITING

Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM

Szczecin, Poland

NOT YET RECRUITING

, Klinika Ginekologii Onkologicznej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie

Warsaw, Poland

NOT YET RECRUITING

Klinika Ginekologii Onkologicznej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie

Warsaw, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 26, 2024
• Study Start: September 2, 2024
• Primary Completion: December 30, 2025
• Study Completion: January 7, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

PL (12)