Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,101

Participants

Timeline

Start Date

June 30, 2017

Primary Completion Date

March 16, 2020

Study Completion Date

April 24, 2024

Conditions
Metastatic Prostate Cancer
Interventions
DRUG

Ipatasertib

Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.

DRUG

Abiraterone

Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.

DRUG

Placebo

Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.

DRUG

Prednisone/Prednisolone

Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.

Trial Locations (176)

7

Mater Misericordiae Uni Hospital, Dublin

Mater Private Hospital, Dublin

24

Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital, Dublin

333

Chang Gung Memorial Hospital-LinKou, Taoyuan District

407

Taichung Veterans General Hospital, Taichung

807

Kaohsiung Medical Uni Chung-Ho Hospital, Kaohsiung City

1007

ICIMED Instituto de Investigación en Ciencias Médicas, San José

1082

Semmelwies University of Medicine, Budapest

1122

Orszagos Onkologiai Intezet, Budapest

1145

Budapesti Uzsoki Utcai Kórház, Budapest

1478

Akershus universitetssykehus HF, Lørenskog

1714

Sykehuset Østfold Kalnes, Grålum

2109

Macquarie University Hospital, Macquarie University

3000

Peter Maccallum Cancer Centre, Melbourne

3128

Eastern Health, Melbourne

3526

B-A-Z County Hospital, Miskolc

4000

CHU Sart-Tilman, Liège

4020

Ordensklinikum Linz Elisabethinen, Linz

5000

Odense Universitetshospital, Onkologisk Afdeling R, Odense

5020

Landeskrankenhaus Salzburg, Salzburg

5037

Adelaide Cancer Centre, Kurralta Park

8036

Lkh-Univ. Klinikum Graz, Graz

8200

Aarhus Universitetshospital, Urologisk Afd. K, Aarhus N

8500

AZ Groeninge, Kortrijk

9000

UZ Gent, Ghent

10103

Clinica CIMCA, San José

10330

Chulalongkorn Hospital, Bangkok

10400

Ramathibodi Hospital, Bangkok

10408

National Cancer Center, Gyeonggi-do

10700

Faculty of Med. Siriraj Hosp., Bangkok

11850

Hospital Angeles Mocel, Mexico City

13620

Seoul National University Bundang Hospital, Gyeonggi-do

14004

Hospital Universitario Reina Sofia, Córdoba

14076

Centre Francois Baclesse, Caen

15212

Allegheny Cancer Center, Pittsburgh

19111

Fox Chase Cancer Center, Philadelphia

20007

Georgetown University Medical Center, Washington D.C.

20089

Istituto Clinico Humanitas, Rozzano

20133

Irccs Istituto Nazionale Dei Tumori (Int), Milan

20153

A.O. San Carlo Borromeo, Milan

20850

Associates in Oncology/Hematology P.C., Rockville

26100

A.O. Istituti Ospitalieri - Cremona, Cremona

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

29414

Charleston Oncology, P .A, Charleston

29572

Carolina Urologic Research Center, Myrtle Beach

30029

Institut de cancerologie du Gard, Nîmes

30342

Northside Hospital, Atlanta

31008

Clinica Universitaria de Navarra, Pamplona

33176

Miami Cancer Institute of Baptist Health, Inc., Miami

33486

Lynn Cancer Institute/Boca Raton Regional Hospital, Boca Raton

34000

Consultorio de Especialidad en Urologia Privado, Durango

34298

Institut régional du Cancer Montpellier, Montpellier

38122

Ospedale di Trento-Presidio Ospedaliero Santa Chiara, Trento

41013

Hospital Universitario Virgen del Rocio, Seville

41100

A.O. Universitaria Policlinico Di Modena, Modena

44195

Cleveland Clinic, Cleveland

47014

I.R.S.T Srl IRCCS, Meldola

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48201

Karmanos Cancer Institute.., Detroit

49055

ICO Paul Papin, Angers

50139

Azienda Ospedaliero-Universitaria Careggi, Florence

50200

Maharaj Nakorn Chiangmai Hospital, Chiang Mai

52100

Ospedale Area Aretina Nord, Arezzo

59000

Hopital Claude Huriez, Lille

61615

Illinois Cancer Care, Peoria

63011

Centre Jean Perrin, Clermont-Ferrand

64132

HCA Midwest Division, Kansas City

68130

Urology Cancer Center & GU Research Network, Omaha

75674

Institut Mutualiste Montsouris, Paris

77380

Texas Oncology - Gulf Coast, The Woodlands

80045

University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora

80131

Istituto Nazionale Tumori Irccs Fondazione G. Pascale, Napoli

85025

Mayo Clinic Arizona, Scottsdale

CHD Vendée, La Roche-sur-Yon

85224

Ironwood Cancer & Research Centers, Chandler

86021

CHU Poitiers, Poitiers

89169

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley, Las Vegas

90033

USC Norris Cancer Center, Los Angeles

91010

City of Hope, Duarte

92151

Hopital Foch, Suresnes

92868

UC Irvine Medical Center, Orange

94115

Pacific Hematology Oncology Associates, San Francisco

94160

Hopital d'Instruction des Armees de Begin, Saint-Mandé

94305

Stanford University, Palo Alto

94805

Institut Gustave Roussy, Villejuif

97062

Northwest Cancer Specialists, P.C., Tualatin

97070

Medical Care & Research, Mérida

100050

Beijing Friendship Hospital Affiliated of Capital University of Medical Science, Beijing

115478

Blokhin Cancer Research Center, Moscow

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

200032

Fudan University Shanghai Cancer Center, Shanghai

Zhongshan Hospital Fudan University, Shanghai

210009

Jiangsu Cancer Hospital, Nanjing

210029

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing

603001

Privolzhsk Regional Medical Center, Nizhny Novgorod

656049

Altai Regional Oncological Center, Barnaul

710061

First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an

3109601

Rambam Health Care Campus, Haifa

4428164

Meir Medical Center, Kfar Saba

4941492

Belinson Medical Center, Division of Oncology, Petah Tikva

5262000

Chaim Sheba medical center, Oncology division, Ramat Gan

59040150

Liga Norte Riograndense Contra O Câncer, Natal

06520

Yale Cancer Center, New Haven

02111

Tufts Medical Center, Boston

02215

Dana-Farber Cancer Institute, Boston

07601

Hackensack Univ Medical Center, Hackensack

02903

Rhode Island Hospital, Providence

84132-0001

Huntsman Cancer Institute, Salt Lake City

VIC 3165

Monash Medical Centre, EAST Bentleigh

31190-131

Hospital Luxemburgo, Belo Horizonte

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

V5Z 4E6

BCCA-Vancouver Cancer Centre, Vancouver

L8V 5C2

Hamilton Health Sciences - Juravinski Cancer Centre, Hamilton

L1G 2B9

Lakeridge Health Oshawa, Oshawa

M4N 3M5

Sunnybrook Research Institute, Toronto

M5G 2M9

Princess Margaret Cancer Center, Toronto

H3T 1E2

Jewish General Hospital, Montreal

H4J 1C5

Hopital Sacre-Coeur Research Centre, Montreal

G1J 1Z4

CHU de Québec - Université Laval - Hôtel-Dieu de Québec, Québec

06189

Centre Antoine Lacassagne, Nice

115 28

Alexandras Hospital, Athens

155 62

IASO General Hospital of Athens, Athens

265 04

University Hospital of Patras Medical Oncology, Pátrai

546 29

Papageorgiou General Hospital, Thessaloniki

H4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

DUMMY_VALUE

Cork University Hospital, Cork

Centro Medico Culiacan SA de CV, Culiacán

00152

Azienda Ospedaliera San Camillo Forlanini, Rome

466-8560

Nagoya University Hospital, Aichi

036-8563

Hirosaki University Hospital, Aomori

277-8577

National Cancer Center East, Chiba

285-8741

Toho University Sakura Medical Center, Chiba

371-8511

Gunma University Hospital, Gunma

003-0804

National Hospital Organization Hokkaido Cancer Center, Hokkaido

920-8641

Kanazawa University Hospital, Ishikawa

232-0024

Yokohama City University Medical Center, Kanagawa

252-0375

Kitasato University Hospital, Kanagawa

783-8505

Kochi Medical School Hospital, Kochi

860-8556

Kumamoto University Hospital, Kumamoto

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

951-8520

Niigata University Medical & Dental Hospital, Niigata

589-8511

Kindai University Hospital, Osaka

113-8603

Nippon Medical School Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

160-8582

Keio University Hospital, Tokyo

181-8611

Kyorin University Hospital, Tokyo

755-8505

Yamaguchi University Hospital, Yamaguchi

93-513

Woj. Wielospec. Centrum Onkologii i Traumatologii, ?ód?

45-060

SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego, Opole

02-781

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie, Warsaw

04-073

Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o., Warsaw

53-413

Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii, Wroclaw

3000-075

HUC, Coimbra

1649-035

Hospital de Santa Maria, Lisbon

4200-072

IPO do Porto, Porto

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06273

Gangnam Severance Hospital, Seoul

06351

Samsung Medical Center, Seoul

07014

Hospital Universitario Son Espases, Palma de Mallorca

08916

Institut Catala d?Oncologia Hospital Germans Trias i Pujol, Badalona

08908

Insititut Catala D'Oncologia, L'Hospitalet de Llobregat

08208

Corporacio Sanitaria Parc Tauli, Sabadell

08036

Hospital Clinic i Provincial, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

BB2 3HH

Royal Blackburn Hospital, Blackburn

LE1 5WW

Leicester Royal Infirmary, Leicester

M20 4BX

The Christie NHS Foundation Trust, Manchester

HA6 2RN

Mount Vernon & Watford Trust Hospital, Northwood

SM2 5PT

Royal Marsden Hospital, Sutton

WV10 0QP

Royal Wolverhampton hospital, Wolverhampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03072238 - Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer | Biotech Hunter | Biotech Hunter