Prostate

TITRE Étude de phase II portant sur le Savolitinib, un inhibiteur du CMET, chez des patients qui ont un cancer de la prostate métastatique résistant à la castration.
PROTOCOLE ID IND.234B
CLINICAL TRIAL.gov ID NCT03385655
TYPE(S) DE CANCER Prostate
PHASE Phase II
TYPE D'ÉTUDE
INSTITUTION CHUM
1051 rue Sanguinet
(514) 890-8000
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Fred Saad
COORDONATEUR(RICE) Amal Nadiri
amal.nadiri.chum@ssss.gouv.qc.ca
514-890-8000 poste 26074
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ

Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234.

  • Men of childbearing potential must have agreed to use a highly effective contraceptive method during Study Drug treatment and for 6 months after stopping treatment and should not father a child or donate sperm during this period.
  • Patients with significantly abnormal liver diseases including viral/other hepatitis, current alcohol abuse or cirrhosis are not eligible.
  • Patients in whom strong inducers or inhibitors of CYP3A4 and strong inhibitors of CYP1A2 cannot be discontinued within 2 weeks before the first dose of savolitinib (3 weeks for St John's Wort) are not eligible.
CRITÈRES D'EXCLUSION (EN)