Ovarian, tubular or peritoneal high-grade epithelial carcinoma, histologically proven. Recommendation of a maintenance treatment with Niraparib at standard dose (200-300mg/day) MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ZEJULA 100mg gélule
Pharmaceutical Form: Capsule
INN or Proposed INN: NIRAPARIB
Other descriptive name: ZEJULA 100mg
Concentration unit: millilitre(s)/gram
Concentration type: equal
Concen
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient Study Information and written informed consent • Social Security Affiliation • Patient > 18 years old. • Ovarian, tubular or peritoneal high-grade epithelial carcinoma, histologically proven. - Patients who already received 4 to 6 cures of Platinum-based chemotherapy and with recommendation of a maintenance treatment with Niraparib at standard dose (300mg/day) or at a reduced dose (200mg/day) • glomerular filtration rate with standardized serum creatinine values using CKD-EPI formula = 30ml/min/1.73m2 (https://www.kidney.org/professionals/kdoqi/gfr_calculator) • Normal liver function with bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Miner patient • Pregnant or lactating woman • Patient not able to understand the aim of the study or under curatorship • Low grade carcinoma • hypersensitivity to active substance or any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Identification of clinical/biological/therapeutic or niraparib pharmacokinetic factors that induces hematologic toxicity or nephrotoxicity when it is used according to the Market authorization at the 300mg/day dose or the reduced 200mg/day dose commonly prescribed for high grade serous epithelial ovarian cancer irrespectively of their BRCA-mutated gene or HR status).;Secondary Objective: Identification of clinical and biological/therapeutic/dietary factors that influence Niraparib pharmacokinetic parameters Determination of the existence of a causative link between pharmacokinetics parameters and Niraparib efficacy;Primary end point(s): Identification of clinical/biological/therapeutic and pharmacokinetic factors that induces hematologic toxicity or nephrotoxicity;Timepoint(s) of evaluation of this end point: Visits n°2, 3, 4 and end of research | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison between clinical and biological/therapeutic/dietary factors and Niraparib pharmacokinetic parameters Determination of the existence of a causative link between pharmacokinetics parameters and progresion free Survival at 24 months ;Timepoint(s) of evaluation of this end point: Visits n°2, 3, 4 and end of research In medical chart : After 24 months of treatment | — |
Countries
France
Contacts
Public ContactRegulatory Project Manager
Hospices Civils de Lyon
Outcome results
None listed