Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
NCT ID: NCT01485861
Last Updated: 2023-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
298 participants
INTERVENTIONAL
2012-01-11
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase Ib: Ipatasertib 400 mg + abiraterone
Participants will receive ipatasertib 400 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Abiraterone
Orally once daily
Ipatasertib
Orally once daily
Prednisone
Orally bid
Prednisolone
Orally bid
Phase Ib: Apitolisib 30 mg + abiraterone
Participants will receive apitolisib 30 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Abiraterone
Orally once daily
Apitolisib
Orally once daily
Prednisone
Orally bid
Prednisolone
Orally bid
Phase II: Ipatasertib 400 mg + abiraterone
Participants will receive Ipatasertib 400 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Abiraterone
Orally once daily
Ipatasertib
Orally once daily
Prednisone
Orally bid
Prednisolone
Orally bid
Phase II: Ipatasertib 200 mg + abiraterone
Participants will receive Ipatasertib 200 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Abiraterone
Orally once daily
Ipatasertib
Orally once daily
Prednisone
Orally bid
Prednisolone
Orally bid
Phase II: Placebo + abiraterone
Participants will receive placebo (for Ipatasertib) once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.
Abiraterone
Orally once daily
Placebo
Orally once daily
Prednisone
Orally bid
Prednisolone
Orally bid
Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone
Participants will receive ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.
Abiraterone
Orally once daily
Ipatasertib
Orally once daily
Prednisone
Orally bid
Prednisolone
Orally bid
Interventions
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Abiraterone
Orally once daily
Apitolisib
Orally once daily
Ipatasertib
Orally once daily
Placebo
Orally once daily
Prednisone
Orally bid
Prednisolone
Orally bid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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 Králové, , Czechia
Urocentrum Praha s.r.o.
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni
Prague, , 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-Mandé, , 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
Pátrai, , 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, Lombardy, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, Italy
Ospedale S. Donato; Divisione Di Reumatologia
Arezzo, Tuscany, Italy
Het Nederlands Kanker Inst
Amsterdam, , Netherlands
Vu Medisch Centrum; Afdeling Longziekten
Amsterdam, , Netherlands
UMC St Radboud
Nijmegen, , Netherlands
Sint Franciscus Gasthuis; Inwendige Geneeskunde
Rotterdam, , Netherlands
MC Haaglanden; Oncologie
The Hague, , 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
Timișoara, , 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, Navarre, 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
Málaga, , 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
Countries
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Other Identifiers
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2011-004126-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO27983
Identifier Type: -
Identifier Source: org_study_id
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