Etude : NIQOLE /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : NIQOLE

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 06/08/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude longitudinale évaluant, en conditions réelles d’utilisation, la tolérance du Niraparib en maintenance après une chimiothérapie à base de platine chez des patientes atteintes d’un cancer de l’ovaire en rechute tardive

Spécialité : Seins, organes génitaux de la femme
Localisation : C56 - Tumeur maligne de l'ovaire
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.
he aim of NiQoLe 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 data 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.

Experimental: NIRAPARIB
Oral Niraparib Daily
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.

Phase : IV

Stade : Localisé à Métastatique

1, 2, 3, 4, X
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Female patients must be ≥ 18 years of age.
- Signed informed consent and ability to comply with treatment and follow-up.
- Patients with histologically proved high grade epithelial ovarian cancer or fallopian tube or primary peritoneal adenocarcinoma.
- Patients who relapse at least 6 months after the last dose of platine based chemotherapy (with no limitation of numbers of previous lines of chemotherapy).
- Platine sensitive patients with a complete response or partial response after a line of platine based chemotherapy.
- Participant must have adequate organ function
- Patients with an indication of maintenance by Niraparib after platine based chemotherapy according to the labelling.
- 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.
- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
- Participant must agree to not donate blood during the study or for 90 days after the last dose of Niraparib.
- 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 non-childbearing potential.
- Participant must agree to not breastfeed during the study or for 1 month after the last dose of Niraparib.

Critères de non-inclusion : - Known hypersensitivity or allergy to active principle or to any components or excipients of the Niraparib formulation.
- Participant must not be simultaneously enrolled in any interventional clinical trial.
- Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- 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.
- Participant last treatment with platinum-based chemotherapy was ≥ 12 weeks from initiation of protocol therapy
- 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. - - - - -
- Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
- Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
- 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.
- Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- 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.
- Participant must not be deprived of liberty, under guardianship or under trusteeship.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03752216
Promoteur :
ARCAGY-GINECO
Type de sponsor : Institutionnel
75004 PARIS 04

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Pierre-Emmanuel BRACHET

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Ouverture de l'essai : OUVERT

MAJ : 15/04/2019