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

NCT03752216 | Completed Phase 4 DMC

• 2 other identifiers: GINECO-OV239B2018-002274-44
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 30

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.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Anti-PARP (poly-ADP ribose polymerase); Late Relapse

Outcome Measures

Primary Outcomes (1)

• Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction).

  Evaluate treatment toxicities

  3 months

Secondary Outcomes (13)

• Self-reported fatigue by patient by FACT-F questionnaire (Functional Assessment of Cancer Therapy General - Fatigue)

  Up to 18 months.

• Self-reported symptoms and side effects with the NCI PRO-CTCAE

  Up to 18 months.

• Reasons of the dose modification of Niraparib

  Up to 18 months.

• General health-related quality of life by FACT-G questionnaire (Functional Assessment of Cancer Therapy General)

  Up to 18 months.

• Pain related to the treatment by Visual Analogic Scale (VAS)

  Up to 18 months.

Study Arms (1)

NIRAPARIB

EXPERIMENTAL

Oral Niraparib Daily

Drug: Niraparib

Interventions

Niraparib DRUG

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.

NIRAPARIB

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I-1 Female patients must be ≥ 18 years of age. I-2 Signed informed consent and ability to comply with treatment and follow-up. I-3 Patients with histologically proved high grade epithelial ovarian cancer or fallopian tube or primary peritoneal adenocarcioma.
• I-4 Platine sensitive and ovarian, fallopian or peritoneal cancer recurrent patients with a complete response or partial response after a line of platine based chemotherapy.
• I-5 Participant must have adequate organ function, defined as follows:
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
• Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN I-6 Patients with an indication of maintenance by Niraparib after platine based chemotherapy according to the labelling (see appendix 17).
• I-7 As this study will include patients in France, a subject will be eligible in this study only if either affiliated to, or a beneficiary of, a social category.
• I-8 Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• I-9 Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
• I-10 Participant must agree to not donate blood during the study or for 90 days after the last dose of Niraparib.
• I-11 Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 1 month after the last dose of study treatment, or is of nonchildbearing potential.
• I-12 Participant must agree to not breastfeed during the study or for 1 month after the last dose of Niraparib.

You may not qualify if:

• E-1 Known hypersensitivity or allergy to active principle or to any components or excipients of the Niraparib formulation.
• E-2 Participant must not be simultaneously enrolled in any interventional clinical trial.
• E-3 Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
• E-4 Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
• E-5 Participant last treatment with platinum-based chemotherapy was ≥12 weeks from initiation of protocol therapy E-6 Participant has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
• E-7 Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks NiQoLe - Study protocol - v3.0 on 08/10/2020 Page 10 on 109 N° EudraCT: 2018-002274-44 prior to initiating protocol therapy. E-8 Participant must not have received colony stimulating factors (e.g., granulocyte colonystimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy. E-9 Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment. E-10 Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). E-11 Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. E-12 Participant must not be deprived of liberty, under guardianship or under trusteeship.

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead
• Tesaro, Inc.: collaborator

Study Sites (30)

Sainte-Catherine Institut du Cancer Avignon-Provence

Avignon, 84918, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, 64109, France

Location

CHRU Jean Minjoz

Besançon, 25030, France

Location

Clinique Tivoli

Bordeaux, 33000, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Hôpital Fleyriat

Bourg-en-Bresse, 01012, France

Location

Centre François Baclesse

Caen, 14000, France

Location

Medipole de Savoie

Challes-les-Eaux, 73190, France

Location

SASU Centre d'Oncologie et Radiothérapie 37

Chambray-lès-Tours, 37170, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Centre Georges François Leclerc

Dijon, 21079, France

Location

Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

Grenoble, 38028, France

Location

Les Hôpitaux de Chartres - Hôpital Louis Pasteur

Le Coudray, 28630, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69373, France

Location

ICM Val d'Aurelle

Montpellier, 34298, France

Location

Médipôle de NANCY / Centre d'Oncologie de Gentilly

Nancy, 54100, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Centre ONCOGARD - Institut de Cancérologie du Gard

Nîmes, 30029, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, 45000, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Groupe Hospitalier Diaconesses-Croix Saint Simon

Paris, 75020, France

Location

Centre CARIO - HPCA

Plérin, 22190, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

Institut du Cancer Courlancy

Reims, 51100, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44600, France

Location

CHU de Saint-Etienne - Pôle de Cancérologie

Saint-Priest-en-Jarez, 42271, France

Location

Centre Hospitalier Saint-Malo

St-Malo, 35400, France

Location

Hôpitaux Universitaires de Strasbourg - Institut de Cancérologie Strasbourg Europe

Strasbourg, 67200, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

Related Publications (1)

• Joly F, Bazan F, Garbay D, Ouldbey Y, Follana P, Champeaux-Orange E, Legouffe E, Brachet PE, Spaeth D, Combe P, Hardy-Bessard AC, Selle F, Grenier J, Lebreton C, Derbel O, Bonnet E, Fournel P, Fernandez Diez Y, Delecroix V, Emambux S, Alexandre J, Grellety T, Mille D, Orfeuvre H, Favier C, Le Roux D, Mouret-Reynier MA, Quesada S, Kurtz JE. Improving real-world evaluation of patient- and physician-reported tolerability: niraparib for recurrent ovarian cancer (NiQoLe). JNCI Cancer Spectr. 2025 Jan 3;9(1):pkae114. doi: 10.1093/jncics/pkae114.

  PMID: 39673810 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Florence JOLY, MD, PhD

  Centre François Baclesse 3, avenue du Général Harris 14076 CAEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 23, 2018
• Study Start: April 3, 2019
• Primary Completion: August 18, 2021
• Study Completion: December 13, 2022
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

FR (30)