Title A Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
Protocole ID IND.234B
ClinicalTrials.gov ID NCT03385655
Cancer Type(s) Prostate
Phase Phase II
Stage
Study Type
Drug Savolitinib
Institution CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
City Montréal
Principal Investigator Dr. Fred Saad
Coordinator Amal Nadiri
514-890-8000 poste 26074
Status Recruiting
Activation Date
Eligibility Criteria 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.
Exclusion Criteria