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.
Key facts
- Who runs it
- Hospices Civils de Lyon
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 4
- People taking part
- 12 people enrolled
- Started
- 5 May 2021
- Ended
- 17 Apr 2025
- Type of study
- Interventional
- Treatments tested
- Pharmacokinetics, Dosage of Niraparib
- Record updated
- 22 May 2025
- Why it stopped
- End of inclusion period.
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries.
Read full original descriptionShow less
Standard treatment for newly diagnosed advanced ovarian cancer consist of cytoreductive surgery and platinum-based chemotherapy with or without concurrent and maintenance bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor.
A majority of women with epithelial ovarian cancer respond well to first-line platinum-based chemotherapy. There is however a high rate of relapse/recurrence (disease progression ranging from 10 to 26 months).
Poly ADP ribose polymerase inhibitors (PARPi), a new class of therapeutic molecules have recently revolutionized this paradigm, demonstrating progression-free survival (PFS) advantages in several trials.
The PARPi molecule Niraparib has obtained its market authorization after the NOVA trial as second maintenance treatment line, irrespectively of patients' BRCA-mutated gene or HR status.
Since, results of the Phase III trial PRIMA, have demonstrated that Niraparib can also provided a significant PFS increase as first line maintenance treatment, for adult patients with platinum-sensitive, relapsed, high grade serous epithelial ovarian cancer who are in response (complete response or partial response) to platinum-based chemotherapy, irrespectively of their BRCA-mutated gene or HR status.
However, despite its high therapeutic potential, Niraparib at standard dose (200 or 300mg/day) is known to lead to hematologic toxicity and/or nephrotoxicity. This was demonstrated during the NOVA trial (the dose of Niraparib having to be reduced in 80% of the patients to reduce toxicity).
A retrospective study of the NOVA trial indicates that 2 predictive factors leading to hematologic toxicity were a weight <77kg and an initial platelet count <175 G/L. However, it seems more complex as 50% of patients with an initial weight between 58 and 77kg have not reported thrombocytopenia. Same for platelet count. Creatinine clearance below 60ml/min and an hypoalbuminemia <35 g/l have also been identified in another study as predictive factors to thrombocytopenia.
The inter-individual heterogeneity in terms of toxicity regarding Niraparib is high and still not well understood.
The aim of our study is therefore to better identify which clinical, biological and pharmacokinetic metrics can be considered as toxicity induction causes when Niraparib is used as maintenance treatment (200 or 300mg/day) for ovarian cancer patients.
The group in the trial
- Pharmacokinetics, Dosage of NiraparibTreatment being tested
Patients received 3 cycles of Niraparib (200 mg or 300 mg/day). Each cycle lasts 28 days. Serum niraparib assays will be performed for all patients over 3 courses immediately prior to treatment (Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1). Close-up kinetic measurements will also be taken at 1 Hour, 2 Hours, 4 Hours, 6 Hours and 24 Hours at Cycle 1 Day 15.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment (300mg or 200 mg/Day) for Ovarian Cancer Patients.
- Record updated
- 22 May 2025