Clinical trial NCT05288166: A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)
Official title: CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Prostatic Neoplasms
Neoplasm Metastasis
Urogenital Neoplasms
Physiological Effects of Drugs
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Abiraterone Acetate
Steroid Synthesis Inhibitors
Cytochrome P-450
Enzyme Inhibitors
Prednisone
Prednisolone
Cyclin-Dependent Kinase 4
Cyclin-Dependent Kinase 6
Keywords: Metastatic Hormone Sensitive Prostate Cancer
mHSPC
Stage IV Prostate Cancer
Recurrent Prostate Cancer
De Novo Metastatic Prostate Cancer
High-Risk
Visceral metastasis
Cyclin-Dependent Kinase 4 (CDK4)
Cyclin-Dependent Kinase 6 (CDK6)
CDK4
CDK6
CDK4/6
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-03-21
Enrollment: 900
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 learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.


Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the prostate (as the predominant histology)
* High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:

  * Greater than or equal to (≥)4 bone metastases by bone scan and/or
  * ≥1 visceral metastases by computed tomography or magnetic resonance imaging
* Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 \& 6) inhibitor
* Development of metastatic prostate cancer in the context of castrate levels of testosterone
* Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
* Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
* History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
* Uncontrolled hypertension
* Clinically active or chronic liver disease, moderate/severe hepatic impairment
* Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization

Primary outcomes:
measure: Radiographic Progression-Free Survival (rPFS) Assessed by Investigator
timeFrame: Randomization to radiographic progression or death from any cause (approximately 48 months)
Secondary outcomes:
measure: rPFS Assessed by Blinded Independent Central Review (BICR)
timeFrame: Randomization to radiographic progression or death from any cause (approximately 48 months)
measure: Castration-resistant Prostate Cancer (CRPC)-free Survival
timeFrame: Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 nanogram/deciliter (ng/dL); or death from any cause (approximately 48 months)
measure: Overall Survival (OS)
timeFrame: Baseline to date of death due to any cause (approximately 60 months)
measure: Time to Pain Progression
timeFrame: Randomization to pain progression (approximately 48 months)
measure: Time to Deterioration in Health-Related Quality of Life (HRQoL)
timeFrame: Randomization to the date of HRQoL deterioration (approximately 48 Months)
measure: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
timeFrame: Postdose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)
Other outcomes:
Locations:
city: Prescott Valley
country: United States
facility: Arizona Oncology Associates, P.C. - HOPE
state: Arizona
city: Prescott
country: United States
facility: Arizona Oncology Associates, P.C. - HOPE
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Cancer Center - North Campus
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer and Blood Institute
state: Arkansas
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Fountain Valley
country: United States
facility: Orange Coast Memorial Medical Center
state: California
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center
state: California
city: Long Beach
country: United States
facility: MemorialCare Health System - Long Beach Medical Center
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: Torrance
country: United States
facility: Torrance Memorial Physician Network / Cancer Care
state: California
city: Whittier
country: United States
facility: PIH Health Hematology Medical Oncology
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Harmony
state: Colorado
city: Grand Junction
country: United States
facility: Colorado West Healthcare System - Grand Valley Oncology
state: Colorado
city: Littleton
country: United States
facility: USO-Rocky Mountain Cancer Center
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - South
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Hollywood
country: United States
facility: Millennium Oncology Research Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialist- East
state: Florida
city: Fort Gordon
country: United States
facility: Dwight D Eisenhower Army Medical Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care DBA Candler Medical Oncology Practice
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Louisville
country: United States
facility: The University of Louisville, James Graham Brown Cancer Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Sarah Cannon Research Institute
state: Louisiana
city: Towson
country: United States
facility: Chesapeake Urology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Reliant Medical Group
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Oncology/Hematology PA
state: Minnesota
city: Clifton
country: United States
facility: Care Access - Clifton
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Cancer Center
state: New York
city: Mineola
country: United States
facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals - Urology
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: Cincinnati
country: United States
facility: TriState Urologic Services PSC Inc.
state: Ohio
city: Tigard
country: United States
facility: Northwest Cancer Specialist
state: Oregon
city: Bala-Cynwyd
country: United States
facility: MidLantic urology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN Allegheny General Hospital
state: Pennsylvania
city: Chattanooga
country: United States
facility: Tennessee Oncology Chattanooga-SCRI
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Balcones
state: Texas
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology - Carrollton
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Sugar Land
country: United States
facility: USO - Texas Oncology Gulf Coast
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: The Woodlands
country: United States
facility: US Oncology Research Network
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Longview Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center Inc.
state: Vermont
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia Inc
state: Virginia
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Asociación de Beneficencia Hospital Sirio Libanés
state: Buenos Air
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Air
city: Buenos Aires
country: Argentina
facility: Investigaciones Clinicas Moleculares (ICM)
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: Fundación Cenit Para La Investigación En Neurociencias
state: Ciudad Autónoma De Buenos Aire
city: Capital
country: Argentina
facility: Centro Medico Privado CEMAIC
state: Córdoba
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Viedma
country: Argentina
facility: Clinica Viedma
state: Río Negro
city: San Miguel de Tucumán
country: Argentina
facility: Centro Medico San Roque
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Centro Oncologico Korben
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Córdoba
country: Argentina
facility: Centro Urológico Profesor Bengió
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University
state: New South Wales
city: South Brisbane
country: Australia
facility: Icon Cancer Centre South Brisbane
state: Queensland
city: Southport
country: Australia
facility: Tasman Oncology Research
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Hobart
country: Australia
facility: Icon Cancer Centre Hobart
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Richmond
country: Australia
facility: Epworth Freemasons
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis Aalst
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan
state: West-Vlaanderen
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
state: Ceará
city: Belo Horizonte
country: Brazil
facility: Centro Avançado de Tratamento Oncológico- CENANTRON
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Centro Integrado de Oncologia de Curitiba
state: Paraná
city: Londrina
country: Brazil
facility: Hospital de Cancer de Londrina
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Santa Cruz do Sul
country: Brazil
facility: Instituto de Oncologia Saint Gallen
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Clínica de Oncologia Reichow
state: Santa Catarina
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto de de Educação, pesquisa e Gestão em Saúde
city: São Paulo
country: Brazil
facility: Instituto do Cancer Arnaldo Vieira de Carvalho
city: São Paulo
country: Brazil
facility: Icesp - Instituto Do Câncer Do Estado de São Paulo
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Bengbu
country: China
facility: Afflilated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University
state: Anhui
city: Wuhu
country: China
facility: Wannan Medical College Yijishan Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Centre
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology
state: Hubei
city: ChangSha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: ChengDu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Nanchong
country: China
facility: Nanchong Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Horovice
country: Czechia
facility: Nemocnice Horovice
state: Beroun
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
state: Brno-město
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne
state: Jihomoravský Kraj
city: PRague
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
state: Praha 10
city: Prague
country: Czechia
facility: Fakultni Thomayerova nemocnice
state: Praha 4
city: Pribram
country: Czechia
facility: Oblastni nemocnice Pribram
state: Příbram
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Prague
country: Czechia
facility: Urocentrum Praha
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
state: Bretagne
city: La Chaussée-Saint-Victor
country: France
facility: Polyclinique De Blois
state: Centre
city: Dijon
country: France
facility: Centre Georges François Leclerc
state: Côte-d'Or
city: Besançon
country: France
facility: CHU Besançon
state: Doubs
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier
state: Languedoc-Roussillon
city: Nantes
country: France
facility: Hôpital privé du Confluent SAS
state: Loire-Atlantique
city: Saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
state: Loire-Atlantique
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Provence-Alpes-Côte-d'Azur
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhône-Alpes
city: Le Mans
country: France
facility: Clinique Victor Hugo Le Mans
state: Sarthe
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: NCT
state: Baden-Württemberg
city: Nürtingen
country: Germany
facility: Studienpraxis Urologie
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-Würt
city: Munich
country: Germany
facility: Klinikum Rechts Der Isar Der Technischen Universität München
state: Bayern
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Duisburg
country: Germany
facility: Urologicum Duisburg Fachärztesozietät - Walsum
state: Nordrhein-Westfalen
city: Heinsberg
country: Germany
facility: Urologische Gemeinschaftspraxis Heinsberg
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus
state: Nordrhein-Westfalen
city: Wesel
country: Germany
facility: Urologische Gemeinschaftspraxis Wesel
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: InVO Institut für Versorgungsforschung in der Onkologie
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität Mainz
state: Rheinland-Pfalz
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Mettmann
country: Germany
facility: Urologie Neandertal - Praxis Mettmann
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaḯa
city: Athens
country: Greece
facility: Agios Savvas Regional Cancer Hospital
state: Attikí
city: Athens
country: Greece
facility: Alexandra Hospital
state: Attikí
city: Chaidari
country: Greece
facility: Attikon General University Hospital
state: Attikí
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Irakleío
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz
state: Bács-Kiskun
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz
state: Győr-Moson-Sopron
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
state: Pest
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
state: Yerushalayim
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
city: Castelfranco Veneto
country: Italy
facility: Istituto Oncologico Veneto IRCCS
state: Veneto
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni
city: Trento
country: Italy
facility: APSS- Presidio Ospedaliero S. Chiara
city: Nagoya
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kisarazu
country: Japan
facility: Kimitsu Chuo Hospital
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kita
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Tomitake
country: Japan
facility: Nagano Municipal Hospital
state: Nagano
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Shinagawa
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Ciudad de México
country: Mexico
facility: Health Pharma Professional Research S.A. de C.V:
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Actualidad Basada en la Investigación del Cáncer
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Culiacan
country: Mexico
facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
state: Noord-Brabant
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Lublin
country: Poland
facility: Clinical Best Solutions
state: Lubelskie
city: Opole
country: Poland
facility: Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
state: Opolskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o. o.
state: Pomorskie
city: Lodz
country: Poland
facility: Salve Medica
state: Łódzkie
city: Piotrkow Trybunalski
country: Poland
facility: Provita Profamilia
state: Łódzkie
city: Brasov
country: Romania
facility: C.M.D.T.A. Neomed
state: Brașov
city: Florești
country: Romania
facility: Amethyst Radiotherapy Center
state: Cluj
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital OCH
state: Constanța
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"
state: Dolj
city: Otopeni
country: Romania
facility: Radiology Therapeutic Center
state: Ilfov
city: Baia Mare
country: Romania
facility: Oncopremium Team
state: Maramureș
city: București
country: Romania
facility: SC Memorial Healthcare International SRL
city: București
country: Romania
facility: Gral Medical Diagnostic Center
city: Hospitalet
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
state: Valenciana, Comunitat
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Taipei
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Stanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi
state: İstanbul
city: Izmir, Karsiyaka
country: Turkey
facility: Izmir Medical Park Hospital
state: İzmir
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi
city: Diyarbakir
country: Turkey
facility: Dicle Üniversitesi
city: Edirne
country: Turkey
facility: Trakya University
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
city: Malatya
country: Turkey
facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital
state: Blackburn With Darwen
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
state: Essex
city: London
country: United Kingdom
facility: University College London Hospital
state: London, City Of
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: