Status:
TERMINATED
NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Adult Patients With Platinum-sensitive, Relapsed, High Grade Serous Epithelial Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries. Standard treatment for newly diagnosed advanced ova...
Eligibility Criteria
Inclusion
- Patient Study Information and written informed consent
- Social Security Affiliation
- Patient \> 18 years old.
- Ovarian, tubular or peritoneal high-grade epithelial carcinoma, histologically proven. Recommendation of a maintenance treatment with Niraparib at standard dose (200-300mg/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 \< 1.5N
- 6-8 weeks break between last chemotherapy and Niraparib treatment initiation.
- Patient with an effective birth control
Exclusion
- Minor patient
- Patient not able to understand the aim of the study or under curatorship
- Low grade carcinoma
- Pregnant or breastfeeding patient
- Hypersensivity to an active substance present in niraparib
Key Trial Info
Start Date :
May 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04861181
Start Date
May 5 2021
End Date
April 17 2025
Last Update
May 22 2025
Active Locations (1)
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1
Hôpital Lyon sud, Institut de Cancérologie des Hospices Civils de Lyon
Pierre-Bénite, France, 69495