Actively Recruiting
Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.
Led by Pomeranian Medical University Szczecin · Updated on 2024-10-23
300
Participants Needed
12
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Niraparib Maintenance Treatment in Patients With Newly Diagnosed Advanced Platinum- Sensitive, OC. The First Poland RWE Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be female, 18 years of age or older, able to understand the study procedures, and provide written informed consent.
- Patients must have a confirmed diagnosis of nonmucinous high-grade epithelial ovarian cancer (serous or endometrial type) at stage III or IV according to FIGO criteria.
- Patients with stage IV disease are eligible, including those with inoperable disease, those who have undergone primary debulking surgery (R0 or macroscopic disease), or those planned for neoadjuvant chemotherapy.
- Patients with stage III disease are eligible if they have residual disease after cytoreductive surgery, have inoperable disease, or have received neoadjuvant chemotherapy.
- Formalin-fixed paraffin-embedded tumor tissue sample must be available for molecular analysis.
- Patients of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment.
- Patients must be postmenopausal, surgically sterilized, willing to use effective contraception, or agree to abstain from pregnancy-risk activities during the study and for 180 days after treatment.
- Patients must have serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥60 mL/min.
- Total bilirubin must be ≤1.5 times the upper limit of normal.
- AST and ALT must be ≤2.5 times the upper limit of normal unless liver metastases are present, in which case ≤5 times the upper limit.
- Patients must have an ECOG performance status of 0 or 1.
- Patients must have normal or controlled hypertension.
- Patients must be able to take oral medication.
You will not qualify if you...
- Patients with mucinous, germ cell, transitional cell, or undifferentiated tumors.
- Patients with low-grade or Grade 1 epithelial ovarian cancer.
- Patients with any condition, therapy, or laboratory abnormality that could interfere with study results or participation.
- Patients who are pregnant, breastfeeding, or planning to conceive during treatment and for 180 days after the last dose.
- Patients with a history or diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Patients with hypersensitivity to niraparib or any of its components, including tartrazine.
- Patients with untreated or uncontrolled hypertension (systolic BP >140 mmHg or diastolic BP >90 mmHg).
- Patients with a prior history of posterior reversible encephalopathy syndrome (PRES).
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Oddział Onkologii Ginekologicznej Białostockiego Centrum Onkologii
Bialystok, Poland
Actively Recruiting
2
Klinika Położnictwa i Ginekologii, Ginekologii Onkologicznej Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Not Yet Recruiting
3
III Klinika Radioterapii i Chemioterapii Narodowego Instytutu Onkologicznego w Gliwicach
Gliwice, Poland
Not Yet Recruiting
4
Świętokrzyskie Centrum Onkologii
Kielce, Poland
Not Yet Recruiting
5
Klinika Ginekologii Onkologicznej Narodowego Instytutu Onkologicznego w Krakowie
Krakow, Poland
Not Yet Recruiting
6
I Katedra i Klinika Ginekologii Onkologicznej i Ginekologii Uniwersytetu Medycznego w Lublinie
Lublin, Poland
Not Yet Recruiting
7
Opolskie Centrum Onkologii
Opole, Poland
Not Yet Recruiting
8
Oddział Onkologii Klinicznej i Radioterapii, Siedleckie Centrum Onkologii
Siedlce, Poland
Not Yet Recruiting
9
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM
Szczecin, Poland
Not Yet Recruiting
10
Klinika Ginekologii Operacyjnej i Onkologii Ginekologicznej Dorosłych i Dziewcząt PUM
Szczecin, Poland
Not Yet Recruiting
11
, Klinika Ginekologii Onkologicznej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie
Warsaw, Poland
Not Yet Recruiting
12
Klinika Ginekologii Onkologicznej, Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie
Warsaw, Poland
Not Yet Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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