Clinical trial 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
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial Testing Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Asymptomatic or Mildly Symptomatic, Previously Untreated, Metastatic Castrate-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Prostate Cancer
Keywords: Metastatic Castrate-Resistant Prostate Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-03-07
Enrollment: 1101
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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)

Primary outcomes:
measure: Investigator-assessed Radiographic Progression-free Survival (rPFS), Per Prostate Cancer Working Group 3 (PCWG3) Criteria in Phosphatase and Tensin Homolog (PTEN) Loss Population
timeFrame: Up to approximately 32 months
measure: Investigator-assessed rPFS, Per PCWG3 Criteria in ITT Population
timeFrame: Up to approximately 32 months
Secondary outcomes:
measure: Overall Survival (OS) in PTEN-loss Population
timeFrame: Up to approximately 6.5 years
measure: OS in ITT Population
timeFrame: Up to approximately 6.5 years
measure: Time to Pain Progression in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: Time to Pain Progression in ITT Population
timeFrame: Up to approximately 5.5 years
measure: Time to Initiation of Cytotoxic Chemotherapy for Prostate Cancer (PC) in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: Time to Initiation of Cytotoxic Chemotherapy for PC in ITT Population
timeFrame: Up to approximately 5.5 years
measure: Time to Function Deterioration Per European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function (PF) Scale and Role Function (RF) Scale in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: Time to Function Deterioration Per EORTC QLQ-C30 PF Scale and RF Scale in ITT Population
timeFrame: Up to approximately 5.5 years
measure: Time to Prostate-specific Antigen (PSA) Progression, Per the PCWG3 Criteria in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: Time to PSA Progression, Per the PCWG3 Criteria in ITT Population
timeFrame: Up to approximately 5.5 years
measure: Time to First Opioid Use in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: Time to First Opioid Use in ITT Population
timeFrame: Up to approximately 5.5 years
measure: Time to Symptomatic Skeletal Event (SSE) in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: Time to SSE in ITT Population
timeFrame: Up to approximately 5.5 years
measure: Objective Response Rate (ORR) Per RECIST V1.1 and PCWG3 Criteria in Participants With Measurable Disease in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: ORR Per RECIST V1.1 and PCWG3 Criteria in Participants With Measurable Disease in ITT Population
timeFrame: Up to approximately 5.5 years
measure: Duration of Confirmed Response (DOCR) in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: DOCR in ITT Population
timeFrame: Up to approximately 5.5 years
measure: PSA Response Rate in PTEN-loss Population
timeFrame: Up to approximately 5.5 years
measure: PSA Response Rate in ITT Population
timeFrame: Up to approximately 5.5 years
measure: Investigator-assessed rPFS Per PCWG3 Criteria in PTEN-loss Population by Next-generation Sequencing (NGS)
timeFrame: Up to approximately 32 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 28 days after last study drug administration (approximately 6.5 years)
measure: Plasma Concentrations of Ipatasertib at Specified Timepoints
timeFrame: 1-3 hours post-dose (Cycle 1, Day 1; Cycle 1 Day 15 and Cycle 3 Day 1) and pre-dose at steady state (Cycle 1 Day 15, Cycle 3 Day 1, Cycle 6 Day 1) (each cycle length= 28 days)
measure: Plasma Concentrations of Abiraterone at Specified Timepoints
timeFrame: Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days)
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Lynn Cancer Institute/Boca Raton Regional Hospital
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute of Baptist Health, Inc.
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Rockville
country: United States
facility: Associates in Oncology/Hematology P.C.
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute..
state: Michigan
city: Kansas City
country: United States
facility: HCA Midwest Division
state: Missouri
city: Omaha
country: United States
facility: Urology Cancer Center & GU Research Network
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
state: Nevada
city: Hackensack
country: United States
facility: Hackensack Univ Medical Center
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Cancer Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Charleston Oncology, P .A
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: The Woodlands
country: United States
facility: Texas Oncology - Gulf Coast
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Macquarie University
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: EAST Bentleigh
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Eastern Health
state: Victoria
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz Elisabethinen
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Belo Horizonte
country: Brazil
facility: Hospital Luxemburgo
state: Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Câncer
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Vancouver
country: Canada
facility: BCCA-Vancouver Cancer Centre
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Cancer Centre
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sacre-Coeur Research Centre
state: Quebec
city: Quebec
country: Canada
facility: CHU de Québec - Université Laval - Hôtel-Dieu de Québec
city: Beijing Shi
country: China
facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: San Jose
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: San Jose
country: Costa Rica
facility: Clinica CIMCA
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Urologisk Afd. K
city: Odense
country: Denmark
facility: Odense Universitetshospital, Onkologisk Afdeling R
city: Angers
country: France
facility: ICO Paul Papin
city: Caen
country: France
facility: Centre Francois Baclesse
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Lille
country: France
facility: Hopital Claude Huriez
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: Institut de cancerologie du Gard
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Poitiers
country: France
facility: CHU Poitiers
city: Saint-Mande
country: France
facility: Hopital d'Instruction des Armees de Begin
city: Suresnes
country: France
facility: Hopital Foch
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Athens
country: Greece
facility: Alexandras Hospital
city: Athens
country: Greece
facility: IASO General Hospital of Athens
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
city: Budapest
country: Hungary
facility: Semmelwies University of Medicine
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Kórház
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Miskolc
country: Hungary
facility: B-A-Z County Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae Uni Hospital
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Belinson Medical Center, Division of Oncology
city: Ramat Gan
country: Israel
facility: Chaim Sheba medical center, Oncology division
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione G. Pascale
state: Campania
city: Meldola
country: Italy
facility: I.R.S.T Srl IRCCS
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena
state: Emilia-Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Cremona
country: Italy
facility: A.O. Istituti Ospitalieri - Cremona
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int)
state: Lombardia
city: Milano
country: Italy
facility: A.O. San Carlo Borromeo
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Arezzo
country: Italy
facility: Ospedale Area Aretina Nord
state: Toscana
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
state: Toscana
city: Trento
country: Italy
facility: Ospedale di Trento-Presidio Ospedaliero Santa Chiara
state: Trentino-Alto Adige
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Aomori
country: Japan
facility: Hirosaki University Hospital
city: Chiba
country: Japan
facility: National Cancer Center East
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Gunma
country: Japan
facility: Gunma University Hospital
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center
city: Kanagawa
country: Japan
facility: Kitasato University Hospital
city: Kochi
country: Japan
facility: Kochi Medical School Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Yamaguchi
country: Japan
facility: Yamaguchi University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Mexico City
country: Mexico
facility: Hospital Angeles Mocel
state: Mexico CITY (federal District)
city: Culiacan
country: Mexico
facility: Centro Medico Culiacan SA de CV
state: Sinaloa
city: Mérida
country: Mexico
facility: Medical Care & Research
state: Yucatan
city: Durango
country: Mexico
facility: Consultorio de Especialidad en Urologia Privado
city: Grålum
country: Norway
facility: Sykehuset Østfold Kalnes
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus HF
city: ?ód?
country: Poland
facility: Woj. Wielospec. Centrum Onkologii i Traumatologii
city: Opole
country: Poland
facility: SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
city: Wroclaw
country: Poland
facility: Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
city: Coimbra
country: Portugal
facility: HUC
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: IPO do Porto
city: Barnaul
country: Russian Federation
facility: Altai Regional Oncological Center
state: Altaj
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center
state: Moskovskaja Oblast
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsk Regional Medical Center
state: Niznij Novgorod
city: Badalona
country: Spain
facility: Institut Catala d?Oncologia Hospital Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Insititut Catala D'Oncologia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical Uni Chung-Ho Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital-LinKou
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.
city: Chiangmai
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Northwood
country: United Kingdom
facility: Mount Vernon & Watford Trust Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kotani N, Wilkins JJ, Wade JR, Dang S, Sutaria DS, Yoshida K, Sundrani S, Ding H, Garcia J, Hinton H, Sane R, Chanu P. Characterization of exposure-response relationships of ipatasertib in patients with metastatic castration-resistant prostate cancer in the IPATential150 study. Cancer Chemother Pharmacol. 2022 Dec;90(6):511-521. doi: 10.1007/s00280-022-04488-2. Epub 2022 Oct 28.
citation: Sweeney C, Bracarda S, Sternberg CN, Chi KN, Olmos D, Sandhu S, Massard C, Matsubara N, Alekseev B, Parnis F, Atduev V, Buchschacher GL Jr, Gafanov R, Corrales L, Borre M, Stroyakovskiy D, Alves GV, Bournakis E, Puente J, Harle-Yge ML, Gallo J, Chen G, Hanover J, Wongchenko MJ, Garcia J, de Bono JS. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2021 Jul 10;398(10295):131-142. doi: 10.1016/S0140-6736(21)00580-8.