Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
NCT ID: NCT03072238
Last Updated: 2025-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1101 participants
INTERVENTIONAL
2017-06-30
2024-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo + Abiraterone
Participants received Placebo plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles.
Abiraterone
Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.
Placebo
Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
Prednisone/Prednisolone
Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.
Ipatasertib + Abiraterone
Participants received Ipatasertib plus Abiraterone (along with Prednisone/Prednisolone), administered orally in 28-day cycles.
Ipatasertib
Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
Abiraterone
Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.
Prednisone/Prednisolone
Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.
Interventions
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Ipatasertib
Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
Abiraterone
Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.
Placebo
Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
Prednisone/Prednisolone
Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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.
* 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
* 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
* 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)
18 Years
MALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
City of Hope
Duarte, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
Stanford University
Palo Alto, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Lynn Cancer Institute/Boca Raton Regional Hospital
Boca Raton, Florida, United States
Miami Cancer Institute of Baptist Health, Inc.
Miami, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Illinois Cancer Care
Peoria, Illinois, United States
Associates in Oncology/Hematology P.C.
Rockville, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute..
Detroit, Michigan, United States
HCA Midwest Division
Kansas City, Missouri, United States
Urology Cancer Center & GU Research Network
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States
Hackensack Univ Medical Center
Hackensack, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Charleston Oncology, P .A
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Macquarie University Hospital
Macquarie University, New South Wales, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia
Monash Medical Centre
EAST Bentleigh, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Eastern Health
Melbourne, Victoria, Australia
Lkh-Univ. Klinikum Graz
Graz, , Austria
Ordensklinikum Linz Elisabethinen
Linz, , Austria
Landeskrankenhaus Salzburg
Salzburg, , Austria
UZ Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU Sart-Tilman
Liège, , Belgium
Hospital Luxemburgo
Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra O Câncer
Natal, Rio Grande do Norte, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton, Ontario, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hopital Sacre-Coeur Research Centre
Montreal, Quebec, Canada
CHU de Québec - Université Laval - Hôtel-Dieu de Québec
Québec, , Canada
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing, , China
Jiangsu Cancer Hospital
Nanjing, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Zhongshan Hospital Fudan University
Shanghai, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
ICIMED Instituto de Investigación en Ciencias Médicas
San José, , Costa Rica
Clinica CIMCA
San José, , Costa Rica
Aarhus Universitetshospital, Urologisk Afd. K
Aarhus N, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense, , Denmark
ICO Paul Papin
Angers, , France
Centre Francois Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
CHD Vendée
La Roche-sur-Yon, , France
Hopital Claude Huriez
Lille, , France
Institut régional du Cancer Montpellier
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Institut de cancerologie du Gard
Nîmes, , France
Institut Mutualiste Montsouris
Paris, , France
CHU Poitiers
Poitiers, , France
Hopital d'Instruction des Armees de Begin
Saint-Mandé, , France
Hopital Foch
Suresnes, , France
Institut Gustave Roussy
Villejuif, , France
Alexandras Hospital
Athens, , Greece
IASO General Hospital of Athens
Athens, , Greece
University Hospital of Patras Medical Oncology
Pátrai, , Greece
Papageorgiou General Hospital
Thessaloniki, , Greece
Semmelwies University of Medicine
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Budapesti Uzsoki Utcai Kórház
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
B-A-Z County Hospital
Miskolc, , Hungary
Cork University Hospital
Cork, , Ireland
Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital
Dublin, , Ireland
Mater Misericordiae Uni Hospital
Dublin, , Ireland
Mater Private Hospital
Dublin, , Ireland
Rambam Health Care Campus
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Belinson Medical Center, Division of Oncology
Petah Tikva, , Israel
Chaim Sheba medical center, Oncology division
Ramat Gan, , Israel
Istituto Nazionale Tumori Irccs Fondazione G. Pascale
Napoli, Campania, Italy
I.R.S.T Srl IRCCS
Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
A.O. Istituti Ospitalieri - Cremona
Cremona, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
A.O. San Carlo Borromeo
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Ospedale di Trento-Presidio Ospedaliero Santa Chiara
Trento, Trentino-Alto Adige, Italy
Ospedale Area Aretina Nord
Arezzo, Tuscany, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Nagoya University Hospital
Aichi, , Japan
Hirosaki University Hospital
Aomori, , Japan
National Cancer Center East
Chiba, , Japan
Toho University Sakura Medical Center
Chiba, , Japan
Gunma University Hospital
Gunma, , Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Yokohama City University Medical Center
Kanagawa, , Japan
Kitasato University Hospital
Kanagawa, , Japan
Kochi Medical School Hospital
Kochi, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Kindai University Hospital
Osaka, , Japan
Nippon Medical School Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Keio University Hospital
Tokyo, , Japan
Kyorin University Hospital
Tokyo, , Japan
Yamaguchi University Hospital
Yamaguchi, , Japan
Hospital Angeles Mocel
Mexico City, Mexico CITY (federal District), Mexico
Centro Medico Culiacan SA de CV
Culiacán, Sinaloa, Mexico
Medical Care & Research
Mérida, Yucatán, Mexico
Consultorio de Especialidad en Urologia Privado
Durango, , Mexico
Sykehuset Østfold Kalnes
Grålum, , Norway
Akershus universitetssykehus HF
Lørenskog, , Norway
Woj. Wielospec. Centrum Onkologii i Traumatologii
?ód?, , Poland
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
Opole, , Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, , Poland
Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
Warsaw, , Poland
Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii
Wroclaw, , Poland
HUC
Coimbra, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
IPO do Porto
Porto, , Portugal
Altai Regional Oncological Center
Barnaul, Altayskiy Kray, Russia
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
Blokhin Cancer Research Center
Moscow, Moscow Oblast, Russia
Privolzhsk Regional Medical Center
Nizhny Novgorod, Niznij Novgorod, Russia
National Cancer Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Institut Catala d?Oncologia Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Insititut Catala D'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Kaohsiung Medical Uni Chung-Ho Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chang Gung Memorial Hospital-LinKou
Taoyuan District, , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.
Bangkok, , Thailand
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, , Thailand
Royal Blackburn Hospital
Blackburn, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Mount Vernon & Watford Trust Hospital
Northwood, , United Kingdom
Royal Marsden Hospital
Sutton, , United Kingdom
Royal Wolverhampton hospital
Wolverhampton, , United Kingdom
Countries
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References
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Matsubara N, de Bono J, Sweeney C, Chi KN, Olmos D, Sandhu S, Massard C, Garcia J, Chen G, Harris A, Schenkel F, Sane R, Hinton H, Bracarda S, Sternberg CN. Safety Profile of Ipatasertib Plus Abiraterone vs Placebo Plus Abiraterone in Metastatic Castration-resistant Prostate Cancer. Clin Genitourin Cancer. 2023 Apr;21(2):230-237.e1. doi: 10.1016/j.clgc.2023.01.001. Epub 2023 Jan 7.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004429-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CO39303
Identifier Type: -
Identifier Source: org_study_id
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