Completed
PHASE4
INTERVENTIONAL
NCT03752216
NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to 141 patients with ovarian cancer in late relapse treated with niraparib according to the labelling In France.
Detailed Description
The aim of NiQoLe, phase IV study is to evaluate tolerability of Niraparib and the management by the physicians of the side-effects in real life in France. The study will also generate complementary data of NOVA trial on longitudinal follow up of closed symptoms and side effects reported by the patients especially with the NCI PRO (Patient-Reported Outcome)-CTCAE system. Specific oncogeriatric data will be collected among on a subgroup of elderly patients.
Interventions
Name:
Niraparib
Type:
DRUG
Description:
Two different doses of Niraparib can be administrated:
For patient who had at baseline (T0) a body weight ≥ 77 kg and a platelet count ≥ 150 000/µL, Niraparib will be administrated at a dose of 300 mg daily. The planned dose of 300 mg daily will be made up of three 100 mg capsules.
For patient who had at baseline (T0) a body weight \< 77 kg or a platelet count \<150 000/µL, Niraparib will be administrated at a dose of 200 mg daily. The planned dose of 200 mg daily will be made up of two 100 mg capsules.
Patient should continue to receive study treatment until disease progression as per RECIST as assessed by the investigator or they do not meet any other discontinuation criteria.
Primary Outcomes
Measure:
Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction).
TimeFrame:
3 months
Description:
Evaluate treatment toxicities
Trial Information
NCT ID
NCT03752216
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
ARCAGY/ GINECO GROUP
Last Updated
December 15, 2025