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Brief Title: Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
Official Title: A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Study ID: NCT01485861
Brief Summary: This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
HonorHealth Research Institute ? Bisgrove, Scottsdale, Arizona, United States
Pacific Hematology Oncology Associates, San Francisco, California, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct), Fort Myers, Florida, United States
Florida Cancer Specialists; Sarasota, Sarasota, Florida, United States
Kaiser Permanente Medical Ctr, Honolulu, Hawaii, United States
Johns Hopkins Univ; Bunting Blaustein Cancer Center, Baltimore, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Urology Cancer Center & GU Research Network, Omaha, Nebraska, United States
New York Cancer and Blood Specialists - Setauket Medical Oncology, East Setauket, New York, United States
Weill Cornell Medical College, New York, New York, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc, Nashville, Tennessee, United States
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie, Hradec Kralove, , Czechia
Urocentrum Praha s.r.o., Praha 2, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni, Praha, , Czechia
ICO Paul Papin; Oncologie Medicale., Angers, , France
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes, Lyon, , France
Hia Du Val De Grace, Paris, , France
Institut Curie; Oncologie Medicale, Paris, , France
GH Paris Saint Joseph; Hopital De Jour Oncologie, Paris, , France
Hopital d'Instruction des Armees de Begin, Saint-Mande, , France
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, , France
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine, Athens, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
University Hospital of Larissa; Oncology, Larissa, , Greece
University Hospital of Patras Medical Oncology, Patras, , Greece
Metropolitan Hospital; 2Nd Oncology Clinic, Piraeus, , Greece
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
Azienda Ospedaliera Istituti Ospitalieri, Cremona, Lombardia, Italy
Irccs Ospedale San Raffaele;Oncologia Medica, Milano, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy
Ospedale S. Donato; Divisione Di Reumatologia, Arezzo, Toscana, Italy
Het Nederlands Kanker Inst, Amsterdam, , Netherlands
Vu Medisch Centrum; Afdeling Longziekten, Amsterdam, , Netherlands
MC Haaglanden; Oncologie, Den Haag, , Netherlands
UMC St Radboud, Nijmegen, , Netherlands
Sint Franciscus Gasthuis; Inwendige Geneeskunde, Rotterdam, , Netherlands
Sf. Constantin Hospital; Oncology, Brasov, , Romania
Prof. Dr. Th. Burghele Clin Urology Hosp, Bucharest, , Romania
Prof. Dr. I. Chiricuta Institute of Oncology, Cluj Napoca, , Romania
ONCOMED - Medical Centre, Timisoara, , Romania
Municipal Hosp Turdal; Oncology, Turda, , Romania
Hospital General Universitario de Elche; Servicio de Oncologia, Elche, Alicante, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Madrid Norte Sanchinarro, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria, Malaga, , Spain
Queen Elizabeth Hospital; Centre for Clinical Haematology, Birmingham, , United Kingdom
Gartnavel General Hospital, Glasgow, , United Kingdom
St. James University Hospital; Pharmacy Department, Leeds, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
The Royal Marsden Hospital, Sutton, , United Kingdom
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR