IRAPK: Study of the relationships between pharmacokinetic properties (PK) and hematological toxicity of niraparib in ovarian cancer
- Conditions
- Patients with high-grade serous epithelial ovarian, tubal or primary peritoneal cancersMedDRA version: 20.0Level: PTClassification code: 10061328Term: Ovarian epithelial cancer Class: 100000004864Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2024-513856-14-00
- Lead Sponsor
- Hospices Civils De Lyon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 42
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method