Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer (IPATential150)

• ClinicalTrials.gov Identifier: NCT03072238
• Recruitment Status: Active, not recruiting
• First Posted: March 7, 2017
• Results First Posted: April 10, 2023
• Last Update Posted: April 16, 2024
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Metastatic Prostate Cancer	Drug: Ipatasertib; Drug: Abiraterone; Drug: Placebo; Drug: Prednisone/Prednisolone	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 30, 2017
• Actual Primary Completion Date: March 16, 2020
• Estimated Study Completion Date: April 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Placebo + Abiraterone; Participants received Placebo plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles.	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.
Experimental: Ipatasertib + Abiraterone; Participants received Ipatasertib plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles.	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: Prednisone/Prednisolone; Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.

Outcome Measures

Primary Outcome Measures :

1. Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (PTEN Loss Population) [ Time Frame: Up to approximately 31 months ]
   Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in participants with phosphatase and tensin homolog (PTEN) - loss tumors (using the Ventana PTEN immunohistochemistry (IHC) assay).
2. Investigator-Assessed Radiographic Progression-Free Survival (rPFS) Per PCWG3 Criteria (Intent-To-Treat (ITT) Population) [ Time Frame: Up to approximately 31 months ]
   Radiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Disease progression for soft tissue is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm in the sum of diameters of target lesions; progression of non target lesions; the appearance of one or more new lesions. Disease progression for bone lesions is defined as 2 or more new lesions compared to baseline followed by a confirmatory bone scan at least 6 weeks later. rPFS will be analyzed in the Intent-to-Treat (ITT) population.

Secondary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: Up to approximately 7 years ]
   Overall Survival (OS) is defined as the time from randomization to death due to any cause. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
2. Time to Pain Progression [ Time Frame: Up to approximately 7 years ]
   Time to pain progression was defined as the time from randomization to the first occurrence of confirmed clinically meaningful cancer-related pain progression event. Cancer-related pain progression refers to pain onset for participants who are asymptomatic at baseline or pain worsening for those who are mildly symptomatic at baseline. Pain severity will be graded on a 10-point scale, with 0=no pain and 10=severe pain. Pain severity progression is defined as a ≥ 2-point absolute increase from baseline. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
3. Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: Up to approximately 7 years ]
   Time to initiation of cytotoxic chemotherapy is defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for prostate cancer. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
4. Time to Function Deterioration [ Time Frame: Up to approximately 7 years ]
   Time to function deterioration was defined as the time from the date of randomisation to the date of 10-point or more decrease on either the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) PF (Physical Functioning) or RF (Role Functioning) scale scores (range, 0-100) held for two consecutive assessments, or a 10 point or more score decrease followed by death (any cause) within 28 days, whichever occurs first. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
5. Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: Up to approximately 7 years ]
   Time to PSA progression is defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria. PSA progression is defined as a PSA increase that is ≥ 25% and ≥ 2 ng/mL above the baseline or the nadir, which is confirmed by a second value ≥ 3 weeks later. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
6. Time to First Opioid Use [ Time Frame: Up to approximately 7 years ]
   Time to first opioid use is defined as the documentation of the first opioid prescription for cancer-related pain followed by the participant's record of opioid intake or availability of an Analgesic Quantification Algorithm (AQA) daily score. Participants reporting use of opioid for cancer-related pain at baseline will be excluded from the analysis. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
7. Time to Symptomatic Skeletal Event (SSE) [ Time Frame: Up to approximately 7 years ]
   Time to SSE is defined as the time interval from the date of randomization to the date of an SSE. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
8. Objective Response Rate (ORR) [ Time Frame: Up to approximately 7 years ]
   An objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator using RECIST v1.1 and PCWG3 criteria, in participants with measurable disease at baseline. Participants without a post-baseline tumor assessment will be considered non-responders. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
9. PSA Response Rate [ Time Frame: Up to approximately 7 years ]
   PSA response rate is defined as the percentage of participants achieving a PSA decline ≥50% from baseline. Participants without a post-baseline PSA assessment will be considered non-responders. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
10. Investigator-Assessed rPFS Per PCWG3 Criteria in Participants With PTEN-Loss Tumors by Next-Generation Sequencing (NGS) [ Time Frame: Up to approximately 7 years ]
    Investigator-assessed rPFS is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first and will be analyzed in participants with PTEN-loss tumors by NGS. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
11. Duration of Response (DOR) [ Time Frame: Up to approximately 7 years ]
    Duration of Response (DOR) is defined as the time from first occurrence of a documented confirmed objective response until the time of documented disease progression as determined by the investigator using RECIST v1.1 and PCWG3 criteria, or death from any cause, whichever occurs first. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
12. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up until 28 days after the last dose of study drug or initiation of subsequent lines of anti-cancer therapy, whichever occurs first (up to a maximum of 7 years). ]
    An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events. Data collection is still ongoing and the results will be disclosed within 1 year from the Study Completion Date.
13. Plasma Concentrations of Ipatasertib at Specified Timepoints [ Time Frame: 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) ]
    Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.
14. Plasma Concentrations of Abiraterone at Specified Timepoints [ Time Frame: Pre-dose at steady state in Cycle 1, Day 15 and Cycle 3 Day 1 (each cycle length= 28 days) ]
    Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Arizona

Ironwood Cancer & Research Centers

Chandler, Arizona, United States, 85224

Mayo Clinic Arizona

Scottsdale, Arizona, United States, 85025

United States, California

USC/Westside Cancer Ctr

Beverly Hills, California, United States, 90211

City of Hope

Duarte, California, United States, 91010

Kaiser Permanente San Diego - Los Angeles

Los Angeles, California, United States, 90027

USC Norris Cancer Center

Los Angeles, California, United States, 90033

UC Irvine Medical Center

Orange, California, United States, 92868

Stanford University

Palo Alto, California, United States, 94305

Pacific Hematology Oncology Associates

San Francisco, California, United States, 94115

United States, Colorado

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States, 80045

United States, Connecticut

Yale Cancer Center

New Haven, Connecticut, United States, 06520

United States, District of Columbia

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

United States, Florida

Lynn Cancer Institute/Boca Raton Regional Hospital

Boca Raton, Florida, United States, 33486

Miami Cancer Institute of Baptist Health, Inc.

Miami, Florida, United States, 33176

United States, Georgia

Northside Hospital

Atlanta, Georgia, United States, 30342

United States, Illinois

Illinois Cancer Care

Peoria, Illinois, United States, 61615

United States, Maryland

Associates in Oncology/Hematology P.C.

Rockville, Maryland, United States, 20850

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

Karmanos Cancer Institute..

Detroit, Michigan, United States, 48201

United States, Missouri

HCA Midwest Division

Kansas City, Missouri, United States, 64132

United States, Nebraska

Urology Cancer Center & GU Research Network

Omaha, Nebraska, United States, 68130

United States, Nevada

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, United States, 89169

United States, New Jersey

Hackensack Univ Medical Center; John Theurer Cancer Ctr

Hackensack, New Jersey, United States, 07601

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44106

United States, Oregon

Northwest Cancer Specialists, P.C.

Tigard, Oregon, United States, 97223

United States, Pennsylvania

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States, 15212

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

United States, South Carolina

Charleston Oncology, P .A

Charleston, South Carolina, United States, 29414

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

United States, Texas

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States, 77380

United States, Utah

Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Australia, New South Wales

Macquarie University Hospital

Macquarie Park, New South Wales, Australia, 2109

Australia, South Australia

Adelaide Cancer Centre

Kurralta Park, South Australia, Australia, 5037

Australia, Victoria

Monash Medical Centre; Oncology

Clayton, Victoria, Australia, 3168

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Eastern Health; GU - Oncology

Melbourne, Victoria, Australia, 3128

Austria

LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

Graz, Austria, 8036

Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

Linz, Austria, 4020

Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

Salzburg, Austria, 5020

Belgium

UZ Gent

Gent, Belgium, 9000

AZ Groeninge

Kortrijk, Belgium, 8500

CHU Sart-Tilman

Liège, Belgium, 4000

Brazil

Hospital Luxemburgo; Oncologia

Belo Horizonte, MG, Brazil, 31190-131

Liga Norte Riograndense Contra O Câncer

Natal, RN, Brazil, 59040150

Hospital Nossa Senhora da Conceicao

Porto Alegre, RS, Brazil, 90040-373

Instituto do Cancer do Estado de Sao Paulo - ICESP

Sao Paulo, SP, Brazil, 01246-000

Canada, British Columbia

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Ontario

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario, Canada, L1G 2B9

Sunnybrook Research Institute

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Center

Toronto, Ontario, Canada, M5G 1Z5

Canada, Quebec

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Hopital Sacre-Coeur Research Centre

Montreal, Quebec, Canada, H4J 1C5

Canada

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

Quebec, Canada, G1J 1Z4

China

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing Shi, China, 100050

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

Nanjing City, China, 210008

Jiangsu Cancer Hospital

Nanjing City, China, 211100

Fudan University Shanghai Cancer Center

Shanghai City, China, 200120

Zhongshan Hospital Fudan University

Shanghai, China, 200032

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

Xi'an, China, 710061

Costa Rica

Clinica CIMCA

San José, Costa Rica, 10103

ICIMED Instituto de Investigación en Ciencias Médicas

San José, Costa Rica, 10108

Denmark

Aarhus Universitetshospital, Urologisk Afd. K

Aarhus N, Denmark, 8200

Odense Universitetshospital, Onkologisk Afdeling R

Odense C, Denmark, 5000

France

ICO Paul Papin; Oncologie Medicale.

Angers, France, 49055

Centre Francois Baclesse; Oncologie

Caen, France, 14076

Centre Jean Perrin

Clermont Ferrand, France, 63011

CHD Vendée

La Roche Sur Yon, France, 85025

Hopital Claude Huriez; Urologie

Lille, France, 59000

Institut régional du Cancer Montpellier

Montpellier, France, 34298

Centre Antoine Lacassagne

Nice, France, 06189

Institut de cancerologie du Gard

Nimes, France, 30029

Institut Mutualiste Montsouris; Oncologie

Paris, France, 75674

CHU Poitiers

Poitiers, France, 86000

Hopital d'Instruction des Armees de Begin

Saint-Mande, France, 94160

Hopital Foch; Oncologie

Suresnes, France, 92151

Institut Gustave Roussy; Departement Oncologie Medicale

Villejuif, France, 94805

Greece

Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

Athens, Greece, 115 28

IASO General Hospital of Athens

Athens, Greece, 155 62

University Hospital of Patras Medical Oncology

Patras, Greece, 265 04

Papageorgiou General Hospital; Medical Oncology

Thessaloniki, Greece, 564 29

Hungary

Semmelwies University of Medicine; Urology Dept.

Budapest, Hungary, 1082

Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

Budapest, Hungary, 1122

Budapesti Uzsoki Utcai Kórház

Budapest, Hungary, 1145

Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

Debrecen, Hungary, 4032

B-A-Z County Hospital

Miskolc, Hungary, 3526

Ireland

Cork University Hospital

Cork, Ireland

Mater Misericordiae Uni Hospital; Oncology

Dublin, Ireland, 7

Mater Private Hospital

Dublin, Ireland, 7

Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

Dublin, Ireland, D24 NR0A

Israel

Rambam Health Care Campus; Oncology

Haifa, Israel, 3109601

Meir Medical Center; Oncology

Kfar-Saba, Israel, 4428164

Belinson Medical Center, Division of Oncology

Petach Tikva, Israel, 4941492

Chaim Sheba medical center, Oncology division

Ramat Gan, Israel, 5262000

Italy

ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

Napoli, Campania, Italy, 80131

I.R.S.T Srl IRCCS; Oncologia Medica

Meldola, Emilia-Romagna, Italy, 47014

A.O. Universitaria Policlinico Di Modena; Oncologia

Modena, Emilia-Romagna, Italy, 41124

Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

Roma, Lazio, Italy, 00152

A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

Cremona, Lombardia, Italy, 26100

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

Milano, Lombardia, Italy, 20133

A.O. San Carlo Borromeo; U.O.C. Oncologia

Milano, Lombardia, Italy, 20153

Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

Rozzano, Lombardia, Italy, 20089

Ospedale Area Aretina Nord; U.O.C. Oncologia

Arezzo, Toscana, Italy, 52100

Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

Firenze, Toscana, Italy, 50139

Ospedale di Trento-Presidio Ospedaliero Santa Chiara; Oncologia Medica

Trento, Trentino-Alto Adige, Italy, 38122

Japan

Nagoya University Hospital

Aichi, Japan, 466-8560

Hirosaki University Hospital

Aomori, Japan, 036-8563

National Cancer Center East

Chiba, Japan, 277-8577

Toho University Sakura Medical Center

Chiba, Japan, 285-8741

Gunma University Hospital

Gunma, Japan, 371-8511

National Hospital Organization Hokkaido Cancer Center

Hokkaido, Japan, 003-0804

Kanazawa University Hospital

Ishikawa, Japan, 920-8641

Yokohama City University Medical Center

Kanagawa, Japan, 232-0024

Kitasato University Hospital

Kanagawa, Japan, 252-0375

Kochi Medical School Hospital

Kochi, Japan, 783-8505

Kumamoto University Hospital

Kumamoto, Japan, 860-8556

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan, 602-8566

Niigata University Medical & Dental Hospital

Niigata, Japan, 951-8520

Kindai University Hospital

Osaka, Japan, 589-8511

Toranomon Hospital

Tokyo, Japan, 105-8470

Nippon Medical School Hospital

Tokyo, Japan, 113-8603

The Cancer Institute Hospital of JFCR

Tokyo, Japan, 135-8550

Keio University Hospital

Tokyo, Japan, 160-8582

Kyorin University Hospital

Tokyo, Japan, 181-8611

Yamaguchi University Hospital

Yamaguchi, Japan, 755-8505

Korea, Republic of

National Cancer Center

Goyang-si, Korea, Republic of, 10408

Seoul National University Bundang Hospital

Seongnam-si, Korea, Republic of, 463-707

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

Asan Medical Center

Seoul, Korea, Republic of, 05505

Gangnam Severance Hospital

Seoul, Korea, Republic of, 06273

Samsung Medical Center

Seoul, Korea, Republic of, 06351

Mexico

Health Pharma Professional Research

Cdmx, Mexico CITY (federal District), Mexico, 03100

Hospital Angeles Mocel

Mexico City, Mexico CITY (federal District), Mexico, 11850

Centro Medico Culiacan SA de CV; Consultorio Medico 303 B

Culiacan, Sinaloa, Mexico

Medical Care & Research

Mérida, Yucatan, Mexico, 97070

Consultorio de Especialidad en Urologia Privado

Durango, Mexico, 34000

Norway

Sykehuset Østfold Kalnes; Onkologisk seksjon

Grålum, Norway, 1714

Akershus universitetssykehus HF

Lørenskog, Norway, 1478

Poland

Woj. Wielospec. Centrum Onkologii i Traumatologii

?ód?, Poland, 93-513

SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego

Opole, Poland, 45-061

Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego

Warszawa, Poland, 02-781

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

Warszawa, Poland, 04-073

Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii

Wroc?aw, Poland, 53-413

Portugal

HUC; Servico de Urologia e Transplantacao Renal

Coimbra, Portugal, 3000-075

Hospital de Santa Maria; Servico de Oncologia Medica

Lisboa, Portugal, 1649-035

IPO do Porto; Servico de Oncologia Medica

Porto, Portugal, 4200-072

Russian Federation

Altai Regional Oncological Center

Barnaul, Altaj, Russian Federation, 656052

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423

Blokhin Cancer Research Center; Urological Dept

Moscow, Moskovskaja Oblast, Russian Federation, 115478

Russian Scientific Center of Roentgenoradiology

Moscow, Moskovskaja Oblast, Russian Federation, 117997

P.A. Herzen Oncological Inst. ; Oncology

Moscow, Moskovskaja Oblast, Russian Federation, 125248

Privolzhsk Regional Medical Center

Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603001

Spain

Institut Catala d?Oncologia Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Insititut Catala D'Oncologia

Hospitalet de Llobregat, Barcelona, Spain, 08908

Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

Sabadell, Barcelona, Spain, 8208

Hospital Universitario Reina Sofia; Servicio de Oncologia

Córdoba, Cordoba, Spain, 14004

Hospital Universitario Son Espases; Servicio de Oncologia

Palma De Mallorca, Islas Baleares, Spain, 07014

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarra, Spain, 31008

Hospital Clinic i Provincial; Servicio de Urología

Barcelona, Spain, 08036

Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

Barcelona, Spain, 08041

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, Spain, 28007

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, Spain, 28034

Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, Spain, 28040

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, Spain, 28041

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Malaga, Spain, 29010

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Sevilla, Spain, 41013

Taiwan

KAOHSIUNG MEDICAL UNI CHUNG-HO HOSPITAL; Dept. Of Urology

Kaohsiung, Taiwan, 807

China Medical University Hospital; Urology

Taichung, Taiwan, 40447

Taichung Veterans General Hospital; Division of Urology

Taichung, Taiwan, 407

Chang Gung Memorial Hospital-LinKou; Urology

Taoyuan, Taiwan, 333

Thailand

Chulalongkorn Hospital; Medical Oncology

Bangkok, Thailand, 10330

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

Bangkok, Thailand, 10400

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

Bangkok, Thailand, 10700

Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

Chiangmai, Thailand, 50200

United Kingdom

Royal Blackburn Hospital

Blackburn, United Kingdom, BB2 3HH

Addenbrookes Nhs Trust; Oncology Clinical Trials Unit

Cambridge, United Kingdom, CB2 0QQ

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Mount Vernon & Watford Trust Hospital; Dept. of Clinical Oncology

Northwood, United Kingdom, HA6 2RN

Royal Marsden Hospital; Institute of Cancer Research

Sutton, United Kingdom, SM2 5PT

Royal Wolverhampton hospital; McHale Building

Wolverhampton, United Kingdom, WV10 0QP

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:

Study Protocol  [PDF] December 23, 2020

Statistical Analysis Plan  [PDF] December 23, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT03072238
• Other Study ID Numbers: CO39303; 2016-004429-17 ( EudraCT Number )
• First Posted: March 7, 2017
• Results First Posted: April 10, 2023
• Last Update Posted: April 16, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hoffmann-La Roche:

Metastatic Castrate-Resistant Prostate Cancer

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Prednisone; Prednisolone; Ipatasertib; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action