Clinical trial NCT03752216: NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.
Official title: Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib in Maintenance After Platine-based Chemotherapy for Patients with Ovarian Cancer Late Relapse : the French GINECO - NiQoLe Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Anti-PARP (poly-ADP ribose polymerase)
Late Relapse
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: Tesaro, Inc.
First posted: 2018-11-23
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction).
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported fatigue by patient by FACT-F questionnaire (Functional Assessment of Cancer Therapy General - Fatigue)
timeFrame: Up to 18 months.
measure: Self-reported symptoms and side effects with the NCI PRO-CTCAE
timeFrame: Up to 18 months.
measure: Reasons of the dose modification of Niraparib
timeFrame: Up to 18 months.
measure: General health-related quality of life by FACT-G questionnaire (Functional Assessment of Cancer Therapy General)
timeFrame: Up to 18 months.
measure: Pain related to the treatment by Visual Analogic Scale (VAS)
timeFrame: Up to 18 months.
measure: Side effects of interest (HTA, anemia, thrombocytopenia)
timeFrame: Up to 18 months.
measure: Duration of Niraparib treatment
timeFrame: Up to 18 months.
measure: Time to first subsequent line of anti-cancer therapy
timeFrame: Up to 18 months.
measure: Overall response rate
timeFrame: Up to 18 months.
measure: Initial cognitive functions by FACT-cog (Functional Assessment of Cancer Therapy - Cognitive Function) questionnaire
timeFrame: At the inclusion visit
measure: Plasma level of Niraparib before Niraparib administration
timeFrame: Day 8
measure: Plasma level of Niraparib before Niraparib administration
timeFrame: 3 months
measure: Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])
timeFrame: Up to 6 months.
Other outcomes:
Locations:
city: Avignon
country: France
facility: Sainte-Catherine Institut du Cancer Avignon-Provence
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Besançon
country: France
facility: CHRU Jean Minjoz
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bourg-en-bresse
country: France
facility: Hôpital Fleyriat
city: Caen
country: France
facility: Centre François Baclesse
city: Challes-les-Eaux
country: France
facility: Medipole de Savoie
city: Chambray-lès-Tours
country: France
facility: SASU Centre d'Oncologie et Radiothérapie 37
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
city: Le Coudray
country: France
facility: Les Hôpitaux de Chartres - Hôpital Louis Pasteur
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Nancy
country: France
facility: Médipôle de NANCY / Centre d'Oncologie de Gentilly
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: Centre ONCOGARD - Institut de Cancérologie du Gard
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses-Croix Saint Simon
city: Plérin
country: France
facility: Centre CARIO - HPCA
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Reims
country: France
facility: Institut du Cancer Courlancy
city: Saint-Malo
country: France
facility: Centre Hospitalier Saint-Malo
city: Saint-nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne - Pôle de Cancérologie
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Institut de Cancérologie Strasbourg Europe
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Centre François Baclesse 3, avenue du Général Harris 14076 CAEN
name: Florence JOLY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: