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Spots Global Cancer Trial Database for Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy

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Trial Identification

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

Conditions

Prostate Cancer

Study Description

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in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trials

Affiliation: Genentech, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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