Prostate Cancer Clinical Trial

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

Summary

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Collaborative Oncology Group (ECOG) performance status of 0 or 1 at screening
Adequate hematologic and organ function within 28 days before the first study treatment
Ability to comply with the study protocol, in the investigator's judgment
Willingness and ability of participants to use the electronic device to report selected study outcomes; Caregivers and site staff can assist with patient diary input but patient must be able to independently comprehend and answer the questionnaires
Life expectancy of at least 6 months
Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
For enrollment into the China extension cohort, residence in the People's Republic of China

Disease-specific Inclusion Criteria:

Histologically confirmed prostate adenocarcinoma without neuroendocrine differentiation or small-cell features
Consent to provide a formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) or a minimum of 15 (20 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue accompanied by an associated pathology report (with tumor content information, Gleason score, and disease staging) for PTEN IHC and NGS testing and for other protocol-mandated secondary and exploratory assessments. If only 12-14 slides are available, the patient may still be eligible for the study, after discussion with and approval by the Medical Monitor. Cytologic or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases is not acceptable
A valid PTEN IHC result (testingcentral laboratory tested with results directly sent to IxRS) (e.g., participants with an "invalid" or "failed" PTEN IHC result are not permitted to enroll)
Metastatic disease documented prior to randomization by clear evidence of bone lesions on bone scan and/or measurable soft tissue disease by computed tomography (CT) and/or magnetic resonance imaging (MRI) (at least one target lesion) according to RECIST v1.1
Asymptomatic or mildly symptomatic form of prostate cancer
Progressive disease before initiating study treatment
Ongoing androgen deprivation with gonadotropin-releasing hormone (GnRH) analog or bilateral orchiectomy, with serum testosterone <= 50 ng/dL (<= 1.7 nmol/L) within 28 days before randomization

Exclusion Criteria:

Inability or unwillingness to swallow whole pills
History of malabsorption syndrome or other condition that would interfere with enteral absorption
Clinically significant history of liver disease consistent with Child-Pugh Class B or C, including cirrhosis, current alcohol abuse, or current known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
Need of more than 10 mg/day of prednisone or an equivalent dose of other anti-inflammatory corticosteroids as a current systemic corticosteroid therapy to treat a chronic disease (e.g., rheumatic disorder)
Active infection requiring intravenous (IV) antibiotics within 14 days before Day 1, Cycle 1
Immunocompromised status because of current known active infection with HIV or because of the use of immunosuppressive therapies for other conditions
Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of the need for major surgery during study treatment
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), untreated coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), myocardial infarction or atrial thrombotic events within the past 6 months, severe unstable angina, New York Heart Association Class III and IV heart disease or depressed left ventricular ejection fraction (LVEF; previously documented LVEF < 50% without documentation of recovery), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome
History of another malignancy within 5 years prior to randomization, except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta, and low grade T1 tumors), or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of <5% at 5 years
Any other diseases, cardiovascular, pulmonary, or metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participants at high risk from treatment complications.

Disease-Specific Exclusion Criteria:

Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate
Any therapy including chemotherapy (e.g., docetaxel) or biological therapy (e.g., vaccine, immunotherapy) for the treatment of castration-resistant prostate cancer. Previous treatment with flutamide, steroidal anti-androgens, androgens, estrogens, bicalutamide, nilutamide, or 5-α reductase inhibitor is permitted.
Use of opioid medications for cancer-related pain, including codeine and dextropropoxyphene, currently or any time within 4 weeks of Day 1, Cycle 1
Prior treatment with abiraterone or other known potent CYP17 inhibitors (e.g., ketoconazole, orteronel) or investigational agents that block androgen synthesis. Previous treatment with itraconazole and fluconazole is permitted.
Prior treatment with enzalutamide or other potent androgen-receptor blockers, approved or experimental (e.g., ARN-509, ODM-201, or galeterone)
Prior treatment with flutamide (Eulexin®), steroidal anti-androgens (e.g., cyproterone acetate, chlormadinone acetate), androgens, or estrogens treatment within 4 weeks of Cycle 1, Day 1
Prior treatment with bicalutamide (Casodex®) or nilutamide (Nilandron®) within 6 weeks of Cycle 1, Day 1
Prior treatment with 5-alpha reductase inhibitors within 4 weeks of Cycle 1, Day 1
Prior treatment with systemic radiopharmaceuticals (e.g., radium-223 and strontium-89). Radiopharmaceuticals for the purpose of imaging are permitted. Focal palliative radiation to treat cancer-related pain is permitted provided that the last treatment with radiation is at least 14 days prior to Cycle 1, Day 1.
Prior treatment with approved or experimental therapeutic agents with known inhibition of the PI3K pathway, including PI3K inhibitors, AKT inhibitors, and mTOR inhibitors
Administration of an investigational therapeutic agent within 28 days of Cycle 1, Day 1
Known untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsant medications or corticosteroids for symptomatic control); a CT or MRI scan of the brain will be performed at screening if required by the local health authority
Any chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or inhibitors or sensitive substrates of CYP3A or CYP2D6 with a narrow therapeutic window

Abiraterone-Specific Exclusion Criteria:

Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg)
History of pituitary or adrenal dysfunction
Any ongoing cardiac arrhythmias (including atrial fibrillation) that require medical therapy

Ipatasertib-Specific Exclusion Criteria:

Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis), active bowel inflammation (e.g., diverticulitis)

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1101

Study ID:

NCT03072238

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 179 Locations for this study

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Ironwood Cancer & Research Centers
Chandler Arizona, 85224, United States
Mayo Clinic Arizona
Scottsdale Arizona, 85025, United States
USC/Westside Cancer Ctr
Beverly Hills California, 90211, United States
City of Hope
Duarte California, 91010, United States
Kaiser Permanente San Diego - Los Angeles
Los Angeles California, 90027, United States
USC Norris Cancer Center
Los Angeles California, 90033, United States
UC Irvine Medical Center
Orange California, 92868, United States
Stanford University
Palo Alto California, 94305, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Lynn Cancer Institute/Boca Raton Regional Hospital
Boca Raton Florida, 33486, United States
Miami Cancer Institute of Baptist Health, Inc.
Miami Florida, 33176, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
Associates in Oncology/Hematology P.C.
Rockville Maryland, 20850, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute..
Detroit Michigan, 48201, United States
HCA Midwest Division
Kansas City Missouri, 64132, United States
Urology Cancer Center & GU Research Network
Omaha Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas Nevada, 89169, United States
Hackensack Univ Medical Center; John Theurer Cancer Ctr
Hackensack New Jersey, 07601, United States
Cleveland Clinic
Cleveland Ohio, 44106, United States
Northwest Cancer Specialists, P.C.
Tigard Oregon, 97223, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Allegheny Cancer Center
Pittsburgh Pennsylvania, 15212, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Charleston Oncology, P .A
Charleston South Carolina, 29414, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Texas Oncology - Memorial City
Houston Texas, 77024, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Macquarie University Hospital
Macquarie Park New South Wales, 2109, Australia
Adelaide Cancer Centre
Kurralta Park South Australia, 5037, Australia
Monash Medical Centre; Oncology
Clayton Victoria, 3168, Australia
Peter Maccallum Cancer Centre
Melbourne Victoria, 3000, Australia
Eastern Health; GU - Oncology
Melbourne Victoria, 3128, Australia
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
Graz , 8036, Austria
Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
Linz , 4020, Austria
Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
Salzburg , 5020, Austria
UZ Gent
Gent , 9000, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Hospital Luxemburgo; Oncologia
Belo Horizonte MG, 31190, Brazil
Liga Norte Riograndense Contra O Câncer
Natal RN, 59040, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 91350, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
BCCA-Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
Sunnybrook Research Institute
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Hopital Sacre-Coeur Research Centre
Montreal Quebec, H4J 1, Canada
CHU de Québec - Université Laval - Hôtel-Dieu de Québec
Quebec , G1J 1, Canada
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing Shi , 10005, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing City , 21000, China
Jiangsu Cancer Hospital
Nanjing City , 21110, China
Fudan University Shanghai Cancer Center
Shanghai City , 20012, China
Zhongshan Hospital Fudan University
Shanghai , 20003, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an , 71006, China
Clinica CIMCA
San José , 10103, Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José , 10108, Costa Rica
Aarhus Universitetshospital, Urologisk Afd. K
Aarhus N , 8200, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C , 5000, Denmark
ICO Paul Papin; Oncologie Medicale.
Angers , 49055, France
Centre Francois Baclesse; Oncologie
Caen , 14076, France
Centre Jean Perrin
Clermont Ferrand , 63011, France
CHD Vendée
La Roche Sur Yon , 85025, France
Hopital Claude Huriez; Urologie
Lille , 59000, France
Institut régional du Cancer Montpellier
Montpellier , 34298, France
Centre Antoine Lacassagne
Nice , 06189, France
Institut de cancerologie du Gard
Nimes , 30029, France
Institut Mutualiste Montsouris; Oncologie
Paris , 75674, France
CHU Poitiers
Poitiers , 86021, France
Hopital d'Instruction des Armees de Begin
Saint-Mande , 94160, France
Hopital Foch; Oncologie
Suresnes , 92151, 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
IASO General Hospital of Athens
Athens , 155 6, Greece
University Hospital of Patras Medical Oncology
Patras , 265 0, Greece
Papageorgiou General Hospital; Medical Oncology
Thessaloniki , 564 2, Greece
Semmelwies University of Medicine; Urology Dept.
Budapest , 1082, Hungary
Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
Budapest , 1122, Hungary
Uzsoki Utcai Korhaz
Budapest , 1145, Hungary
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen , 4032, Hungary
B-A-Z County Hospital
Miskolc , 3526, Hungary
Cork University Hospital
Cork , , Ireland
Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
Dublin , 24, Ireland
Mater Misericordiae Uni Hospital; Oncology
Dublin , 7, Ireland
Mater Private Hospital
Dublin , 7, Ireland
Rambam Health Care Campus; Oncology
Haifa , 31096, Israel
Meir Medical Center; Oncology
Kfar-Saba , 44281, Israel
Belinson Medical Center, Division of Oncology
Petach Tikva , 49414, Israel
Chaim Sheba medical center, Oncology division
Ramat Gan , 52620, Israel
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
Napoli Campania, 80131, Italy
I.R.S.T Srl IRCCS; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
A.O. Universitaria Policlinico Di Modena; Oncologia
Modena Emilia-Romagna, 41100, Italy
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
Roma Lazio, 00152, Italy
A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
Cremona Lombardia, 26100, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano Lombardia, 20133, Italy
A.O. San Carlo Borromeo; U.O.C. Oncologia
Milano Lombardia, 20153, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano Lombardia, 20089, Italy
Ospedale Area Aretina Nord; U.O.C. Oncologia
Arezzo Toscana, 52100, Italy
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
Firenze Toscana, 50139, Italy
Ospedale di Trento-Presidio Ospedaliero Santa Chiara; Oncologia Medica
Trento Trentino-Alto Adige, 38122, Italy
Nagoya University Hospital
Aichi , 466-8, Japan
Hirosaki University Hospital
Aomori , 036-8, Japan
National Cancer Center East
Chiba , 277-8, Japan
Toho University Sakura Medical Center
Chiba , 285-8, Japan
Gunma University Hospital
Gunma , 371-8, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido , 003-0, Japan
Kanazawa University Hospital
Ishikawa , 920-8, Japan
Yokohama City University Medical Center
Kanagawa , 232-0, Japan
Kitasato University Hospital
Kanagawa , 252-0, Japan
Kochi Medical School Hospital
Kochi , 783-8, Japan
Kumamoto University Hospital
Kumamoto , 860-8, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto , 602-8, Japan
Niigata University Medical & Dental Hospital
Niigata , 951-8, Japan
Kindai University Hospital
Osaka , 589-8, Japan
Toranomon Hospital
Tokyo , 105-8, Japan
Nippon Medical School Hospital
Tokyo , 113-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Keio University Hospital
Tokyo , 160-8, Japan
Kyorin University Hospital
Tokyo , 181-8, Japan
Yamaguchi University Hospital
Yamaguchi , 755-8, Japan
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Gangnam Severance Hospital
Seoul , 06273, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Centro Medico Culiacan SA de CV; Consultorio Medico 303 B
Culiacan Sinaloa, , Mexico
Medical Care & Research
Mérida Yucatan, 97070, Mexico
Consultorio de Especialidad en Urologia Privado
Durango , 34000, Mexico
Hospital Angeles Mocel
Mexico City , 11850, Mexico
Sykehuset Østfold Kalnes; Onkologisk seksjon
Grålum , 1714, Norway
Akershus universitetssykehus HF
Lørenskog , 1478, Norway
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
Opole , 45-06, Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego
Warszawa , 02-78, Poland
Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.
Warszawa , 04-07, Poland
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
Wrocław , 53-41, Poland
Woj. Wielospec. Centrum Onkologii i Traumatologii
Łódź , 93-51, Poland
HUC; Servico de Urologia e Transplantacao Renal
Coimbra , 3000-, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisboa , 1649-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Altai Regional Oncological Center
Barnaul , 65604, Russian Federation
Blokhin Cancer Research Center; Urological Dept
Moscow , 11547, Russian Federation
Russian Scientific Center of Roentgenoradiology
Moscow , 11799, Russian Federation
P.A. Herzen Oncological Inst. ; Oncology
Moscow , 12528, Russian Federation
Privolzhsk Regional Medical Center
Nizhny Novgorod , 60300, Russian Federation
Institut Catala d´Oncologia Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Insititut Catala D'Oncologia
Hospitalet de Llobregat Barcelona, 08908, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 8208, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Hospital Universitario Son Espases; Servicio de Oncologia
Palma De Mallorca Islas Baleares, 07014, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital Clinic i Provincial; Servicio de Urología
Barcelona , 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona , 08041, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
KAOHSIUNG MEDICAL UNI CHUNG-HO HOSPITAL; Dept. Of Urology
Kaohsiung , 807, Taiwan
China Medical University Hospital; Urology
Taichung , 40447, Taiwan
Taichung Veterans General Hospital; Division of Urology
Taichung , 407, Taiwan
Chang Gung Memorial Hospital-LinKou; Urology
Taoyuan , 333, Taiwan
Chulalongkorn Hospital; Medical Oncology
Bangkok , 10330, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok , 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok , 10700, Thailand
Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
Chiangmai , 50200, Thailand
Royal Blackburn Hospital
Blackburn , BB2 3, United Kingdom
Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
Cambridge , CB2 0, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology
Northwood , HA6 2, United Kingdom
Royal Marsden Hospital; Institute of Cancer Research
Sutton , SM2 5, United Kingdom
Royal Wolverhampton hospital; McHale Building
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1101

Study ID:

NCT03072238

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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