Etude : ODENZA /



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 : ODENZA

Nom :

Traitement : Métastasique ou localement avancé

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 06/08/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A study of patient preference between ODM-201 and Enzalutamide in men with metastatic castrate-resistant prostate cancer

Spécialité : Organes génitaux masculins
Localisation : C61 - Tumeur maligne de la prostate
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Prospective, randomized, open-label, multicenter, cross-over phase II trial

- Enzalutamide 160 mg/day (4 x 40 mg tablets) taken once a day preferably with food, preferably in the evening (Enzalutamide can generally be given with or without food, but in the present trial, it is preferable that it is given with food, to be consistent with ODM-201 intake).
- ODM-201 1200 mg/day (2 x 300 mg tablets x 2/day) taken twice a day (in the morning and evening in a 12-hour interval) with food.

Phase : II

Stade : Métastatique

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : · Male patients older than 18 years
· Histologically confirmed adenocarcinoma of the prostate
· Evidence of metastatic disease (imaging can include bon scan, CT scan, PET choline, PET PSMA and MRI)
· Continued androgen deprivation therapy (ADT) either with LHRH agonists/antagonists or bilateral orchiectomy
· Serum testosterone <0.50 ng/ml (1.7 nmol/L)
· Progressive disease (PSA progression or radiological progression or clinical progression) as per PCWG3 criteria
· ECOG 0-1 (2 is accepted if the impairement is not due to prostate cancer)
· Asymptomatic or mildly symptomatic (Brief Pain Inventory<4) prostate cancer
· Information imparted to the patient and the informed consent form signed by the patient or his legal representative
· Ability to comply with the protocol procedures
· Patient affiliated to a social security system or beneficiary of the same
· Sexually active male subjects unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the study treatment and for 3 months after the end of the treatment
· adequate organ or bone marrow function as evidenced by:
o Hemoglobin < 9 g/dL
o Absolute neutrophil count <1.5 x 109/L,
o Platelet count <100 x 109/L, (subject must not have received any growth factor within 4 weeks or blood transfusion within 7 days of the hematology laboratory sample obtained at screening)
o AST/SGOT and/or ALT/SGPT >1.5 x ULN;
o Total bilirubin >1.5 x ULN, (except subjects with a diagnosis of Gilbert’s disease),
o Serum creatinine >2 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to the CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded.

Critères de non-inclusion : · Prior treatment with abiraterone, enzalutamide, ODM-201, ARN-509 or any other next-generation AR axis-targeting drug
· Prior treatment with a taxane for CRPC (prior treatment with a taxane for castration-sensitive or castration-naïve prostate cancer is allowed)
· Prior treatment with radium-223
· Patients receiving an investigational drug within 4 weeks prior to enrolment (approved drugs with a long history of use such as aspirin, statins, heparins, or metformin, even used in an experimental setting are accepted)
· Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization
· Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
· Acute toxicities of prior treatments and procedures not resolved to grade <=1 or baseline before randomisation.
· Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association (NYHA) Class III or IV)
· Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal medical management
· Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥5 years before randomization and from which the subject has been disease-free
· A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment
· An active viral hepatitis, active human immunodeficiency infection (HIV), or chronic liver disease with a need for treatment.
· Any other serious or unstable illness or infection, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his compliance with study procedures, or may interfere with the subject’s participation in the study or evaluation of the study results
· Inability to swallow oral medications
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03314324
Promoteur :
Unicancer (IGR)
Type de sponsor : Institutionnel
94800 VILLEJUIF

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 :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Ouverture de l'essai : OUVERT

MAJ : 21/02/2018