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NIRAPK: Study of the relationships between pharmacokinetic properties (PK) and hematological toxicity of niraparib in ovarian cancer
EU CTIS ID: 2024-513856-14-00
What this study is testing
Determination of the existence of links between patient-specific clinical/biological/therapeutic covariates and/or pharmacokinetic parameters of niraparib on the occurrence of hematological and/or renal toxicity(s) when used within the framework of its Marketing Authorization or ATU at 300 mg/day or at 200 mg/day in a reduced dose commonly prescribed, as maintenance treatment for high-grade serous ovarian cancer BRCA mutated or not.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women aged over 18
- Histologically proven high grade serous epithelial ovarian, tubal or primary peritoneal cancer
- Patient who has already received 4 to 6 courses of platinum-based chemotherapy and for whom there is an indication for maintenance treatment with niraparib at a standard dose of 300 mg/day, or at a reduced dose of 200 mg/day at investigator's choice
- Initial glomerular filtration rate according to CKD-EPI formula adjusted for cystatin C ≥ 30ml/min/1.73m2 ((https://www.kidney.org/professionals/kdoqi/gfr_calculator)
- Normal liver function with bilirubinemia < 1.5N
- Interval of 6 to 8 weeks between the last course of platinum-based chemotherapy and the start of treatment with niraparib
You likely can't join if
- Minor patients
- Pregnant or breastfeeding patients
- Patients unable to understand the protocol, or under guardianship-curatorship
- Low grade carcinoma
- Hypersensitivity to the active substance of niraparib or one of these excipients
See the full eligibility criteria
- Women aged over 18
- Histologically proven high grade serous epithelial ovarian, tubal or primary peritoneal cancer
- Patient who has already received 4 to 6 courses of platinum-based chemotherapy and for whom there is an indication for maintenance treatment with niraparib at a standard dose of 300 mg/day, or at a reduced dose of 200 mg/day at investigator's choice
- Initial glomerular filtration rate according to CKD-EPI formula adjusted for cystatin C ≥ 30ml/min/1.73m2 ((https://www.kidney.org/professionals/kdoqi/gfr_calculator)
- Normal liver function with bilirubinemia < 1.5N
- Interval of 6 to 8 weeks between the last course of platinum-based chemotherapy and the start of treatment with niraparib
- For women of childbearing age: contraception deemed effective during treatment and up to 6 months after stopping treatment (hormonal contraception inhibiting ovulation (estrogen + progesterone or progesterone alone), IUD, tubal ligation, abstinence sexual, vasectomy spouse).
- Patient having been informed and having given signed informed consent
- Patient affiliated to a social security scheme or beneficiary of such a scheme
- Minor patients
- Pregnant or breastfeeding patients
- Patients unable to understand the protocol, or under guardianship-curatorship
- Low grade carcinoma
- Hypersensitivity to the active substance of niraparib or one of these excipients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.