NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.

PHASE4CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

April 3, 2019

Primary Completion Date

August 18, 2021

Study Completion Date

December 13, 2022

Conditions
Ovarian Cancer
Interventions
DRUG

Niraparib

"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."

Trial Locations (30)

14000

Centre François Baclesse, Caen

21079

Centre Georges François Leclerc, Dijon

22190

Centre CARIO - HPCA, Plérin

25030

CHRU Jean Minjoz, Besançon

28630

Les Hôpitaux de Chartres - Hôpital Louis Pasteur, Le Coudray

30029

Centre ONCOGARD - Institut de Cancérologie du Gard, Nîmes

31076

Clinique Pasteur, Toulouse

33000

Clinique Tivoli, Bordeaux

33076

Institut Bergonié, Bordeaux

34298

ICM Val d'Aurelle, Montpellier

35400

Centre Hospitalier Saint-Malo, St-Malo

37170

SASU Centre d'Oncologie et Radiothérapie 37, Chambray-lès-Tours

38028

Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard, Grenoble

42271

CHU de Saint-Etienne - Pôle de Cancérologie, Saint-Priest-en-Jarez

44600

Clinique Mutualiste de l'Estuaire, Saint-Nazaire

45000

Centre Hospitalier Régional d'Orléans, Orléans

51100

Institut du Cancer Courlancy, Reims

54100

Médipôle de NANCY / Centre d'Oncologie de Gentilly, Nancy

54519

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

63000

Centre Jean Perrin, Clermont-Ferrand

64109

Centre Hospitalier de la Côte Basque, Bayonne

67200

Hôpitaux Universitaires de Strasbourg - Institut de Cancérologie Strasbourg Europe, Strasbourg

69373

Hôpital Privé Jean Mermoz, Lyon

73190

Medipole de Savoie, Challes-les-Eaux

75014

Hôpital Cochin, Paris

75020

Groupe Hospitalier Diaconesses-Croix Saint Simon, Paris

84918

Sainte-Catherine Institut du Cancer Avignon-Provence, Avignon

86000

Centre Hospitalier Universitaire de Poitiers, Poitiers

01012

Hôpital Fleyriat, Bourg-en-Bresse

06189

Centre Antoine Lacassagne, Nice

All Listed Sponsors
collaborator

Tesaro, Inc.

INDUSTRY

lead

ARCAGY/ GINECO GROUP

OTHER

NCT03752216 - NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib. | Biotech Hunter | Biotech Hunter