Prostate Cancer Clinical Trial

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

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in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy(prior docetaxel is not required for the safety cohort)
Two rising PSA levels greater than or equal to (>/=) 2 ng/mL measured >/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening
Adequate hematologic and organ function
Documented willingness to use an effective means of contraception
Safety cohort only: agreement to use CGM for first cycle of treatment

Exclusion Criteria:

History of Type I or Type II diabetes mellitus requiring insulin; safety cohort: patients who are receiving any pharmacologic treatment for diabetes are not eligible
New York Heart Association Class III or IV heart failure or Left ventricular ejection fraction < 50% or ventricular arrhythmia requiring medication
Significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident within 6 months prior to Day 1
Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy
Clinically significant history of liver disease
History of adrenal insufficiency or hyperaldosteronism
Phase II only: Previous therapy for prostate cancer with 17 alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone
Phase II only: Previous treatment for prostate cancer with Protein kinase B phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors
Need for chronic corticosteroid therapy of >/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

273

Study ID:

NCT01485861

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 59 Locations for this study

See Locations Near You

HonorHealth Research Institute - Bisgrove
Scottsdale Arizona, 85258, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Fort Myers Florida, 33901, United States
Florida Cancer Specialists; Sarasota
Sarasota Florida, 34232, United States
Kaiser Permanente Medical Ctr
Honolulu Hawaii, 96819, United States
Johns Hopkins Univ; Bunting Blaustein Cancer Center
Baltimore Maryland, 21231, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Urology Cancer Center & GU Research Network
Omaha Nebraska, 68130, United States
New York Cancer and Blood Specialists - Setauket Medical Oncology
East Setauket New York, 11733, United States
Weill Cornell Medical College
New York New York, 10065, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville Tennessee, 37203, United States
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie
Hradec Kralove , 50012, Czechia
Urocentrum Praha s.r.o.
Praha 2 , 120 0, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni
Praha , 140 5, Czechia
ICO Paul Papin; Oncologie Medicale.
Angers , 49055, France
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon , 69008, France
Hia Du Val De Grace
Paris , 75230, France
Institut Curie; Oncologie Medicale
Paris , 75231, France
GH Paris Saint Joseph; Hopital De Jour Oncologie
Paris , 75674, France
Hopital d'Instruction des Armees de Begin
Saint-Mande , 94160, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif , 94805, France
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
Athens , 115 2, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion , 711 1, Greece
University Hospital of Patras Medical Oncology
Patras , 265 0, Greece
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus , 185 4, Greece
University Hospital of Larissa; Oncology
Λαρισα , 413 3, Greece
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Azienda Ospedaliera Istituti Ospitalieri
Cremona Lombardia, 26100, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milano Lombardia, 20132, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano Lombardia, 20133, Italy
Ospedale S. Donato; Divisione Di Reumatologia
Arezzo Toscana, 52100, Italy
Het Nederlands Kanker Inst
Amsterdam , 1066 , Netherlands
Vu Medisch Centrum; Afdeling Longziekten
Amsterdam , 1081 , Netherlands
MC Haaglanden; Oncologie
Den Haag , 2512 , Netherlands
UMC St Radboud
Nijmegen , 6525 , Netherlands
Sint Franciscus Gasthuis; Inwendige Geneeskunde
Rotterdam , 3045 , Netherlands
Sf. Constantin Hospital; Oncology
Brasov , 50001, Romania
Prof. Dr. Th. Burghele Clin Urology Hosp
Bucharest , 05065, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca , 40001, Romania
ONCOMED - Medical Centre
Timisoara , 30023, Romania
Municipal Hosp Turdal; Oncology
Turda , 40110, Romania
Hospital General Universitario de Elche; Servicio de Oncologia
Elche Alicante, 03203, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona Barcelona, 08916, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 8208, Spain
Clinica Universitaria de Navarra
Pamplona Navarra, 31008, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Madrid Norte Sanchinarro
Madrid , 28050, Spain
Hospital Clinico Universitario Virgen de la Victoria
Malaga , 29010, Spain
Queen Elizabeth Hospital; Centre for Clinical Haematology
Birmingham , B15 2, United Kingdom
Gartnavel General Hospital
Glasgow , G12 0, United Kingdom
St. James University Hospital; Pharmacy Department
Leeds , LS9 7, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool , L7 8Y, United Kingdom
Sarah Cannon Research Institute
London , W1G 6, United Kingdom
The Royal Marsden Hospital
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

273

Study ID:

NCT01485861

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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