Etude : OREO /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


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

Nom :

Traitement : Adjuvant

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 28/11/2017
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase IIIb, multicentrique, randomisée, en double aveugle contre placebo, de l'Olaparib en traitement d'entretien chez des patientes atteintes de cancer épithélial de l'ovaire précédemment traité par iPARP et répondant à une nouvelle chimiothérapie à base de platine

Spécialité : Seins, organes génitaux de la femme
Localisation : C56 - Tumeur maligne de l'ovaire

Spécialité : Tissu mésothélial et tissus mous
Localisation : C48 - Tumeur maligne du rétropéritoine et du péritoine
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy.

2 arms:
- Experimental: Active Comparator: Olaparib
Olaparib 300mg tablets administered orally twice daily continuously.
- Placebo Comparator: Placebo Comparator: Placebo
Matching placebo 300mg tablets administered orally twice daily continuously.

Phase : IIIb

Stade : I à IV

2, 3, 4
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Provision of informed consent prior to any study specific procedures
- Female patients ≥18 years of age, with histologically diagnosed relapsed non-mucinous EOC (including primary peritoneal and/or fallopian tube cancer)
- Documented BRCA1/2 status.
- Patients must have received one prior PARPi therapy or blinded treatment in a trial with a PARPi as the experimental arm.
- Patients must have normal organ and bone marrow function measured within 28 days of randomization.
- Eastern Cooperative Oncology Group performance status 0-1.
- Patients must have a life expectancy ≥16 weeks.
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment.
- A formalin fixed, paraffin embedded (FFPE) tumour sample from the cancer of sufficient quantity and quality (as specified in the Central Laboratory Services Manual) must be available for future central testing of tumour genetic status.
- For inclusion in the optional biomarker research, patients must sign an informed consent for biomarker research.

Critères de non-inclusion : - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous randomisation in the present study.
- -Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation.
- Other malignancy within the last 5 years except the ones detailed in the exclusion criteria section of study protocol.
- Resting electrocardiogram (ECG) with corrected QT interval (QTc) >470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative radiotherapy) within 3 weeks prior to study treatment.
- Concomitant use of known strong cytochrome P450 (CYP) subfamily 3A (CYP3A) inhibitors or moderate CYP3A inhibitors.
- Concomitant use of known strong or moderate CYP3A inducers.
- Persistent toxicities (Common Terminology Criteria for Adverse Event [CTCAE] grade 2 or higher) caused by previous cancer therapy, excluding alopecia.
- Patients with current or previous myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML.
- Patients with symptomatic uncontrolled brain metastases.
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- Breast feeding women.
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
- Patients with a known hypersensitivity to Olaparib or any of the excipients of the product.
- Patients with a known previous allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT) and also patient with active hepatitis (i.e., Hepatitis B or C) and hypersensitivity to Olaparib.
- Whole blood transfusions in the last 120 days prior to randomisation to the study (packed red blood cells and platelet transfusions are acceptable).
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
AstraZeneca
Type de sponsor : Industriel
00000 HORS FRANCE

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 :
Florence JOLY

TEC / ARC / IDE :
Astrid LETIEMBRE
a.letiembre@
baclesse.unicancer.fr

Ouverture de l'essai : OUVERT

MAJ : 02/02/2018