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

NCT ID: NCT03752216

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-03
• Study Completion Date: 2022-12-13

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.

Conditions

Ovarian Cancer

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NIRAPARIB

Oral Niraparib Daily

Group Type: EXPERIMENTAL

Niraparib

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

I-13 Participant must have normal blood pressure or adequately treated and controlled hypertension

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tesaro, Inc.

INDUSTRY

Sponsor Role: collaborator

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence JOLY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse 3, avenue du Général Harris 14076 CAEN

Locations

Sainte-Catherine Institut du Cancer Avignon-Provence

Avignon, , France

Centre Hospitalier de la Côte Basque

Bayonne, , France

CHRU Jean Minjoz

Besançon, , France

Clinique Tivoli

Bordeaux, , France

Institut Bergonié

Bordeaux, , France

Hôpital Fleyriat

Bourg-en-Bresse, , France

Centre François Baclesse

Caen, , France

Medipole de Savoie

Challes-les-Eaux, , France

SASU Centre d'Oncologie et Radiothérapie 37

Chambray-lès-Tours, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Georges François Leclerc

Dijon, , France

Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

Grenoble, , France

Les Hôpitaux de Chartres - Hôpital Louis Pasteur

Le Coudray, , France

Hôpital Privé Jean Mermoz

Lyon, , France

ICM Val d'Aurelle

Montpellier, , France

Médipôle de NANCY / Centre d'Oncologie de Gentilly

Nancy, , France

Centre Antoine Lacassagne

Nice, , France

Centre ONCOGARD - Institut de Cancérologie du Gard

Nîmes, , France

Centre Hospitalier Régional d'Orléans

Orléans, , France

Hôpital Cochin

Paris, , France

Groupe Hospitalier Diaconesses-Croix Saint Simon

Paris, , France

Centre CARIO - HPCA

Plérin, , France

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Institut du Cancer Courlancy

Reims, , France

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, , France

CHU de Saint-Etienne - Pôle de Cancérologie

Saint-Priest-en-Jarez, , France

Centre Hospitalier Saint-Malo

St-Malo, , France

Hôpitaux Universitaires de Strasbourg - Institut de Cancérologie Strasbourg Europe

Strasbourg, , France

Clinique Pasteur

Toulouse, , France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39673810 (View on PubMed)

Other Identifiers

2018-002274-44

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GINECO-OV239B

Identifier Type: -

Identifier Source: org_study_id