CYCLONE 3: 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)
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05288166
Collaborator
(none)
900
297
2
65.6
3
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Apr 14, 2022
Anticipated Primary Completion Date
:
Oct 1, 2025
Anticipated Study Completion Date
:
Oct 1, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Abemaciclib + Abiraterone + Prednisone/Prednisolone Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally. |
Drug: Abemaciclib
Administered orally.
Other Names:
Drug: Abiraterone
Administered orally.
Drug: Prednisone or Prednisolone
Administered orally.
|
| Active Comparator: Placebo + Abiraterone + Prednisone/Prednisolone Placebo + abiraterone + prednisone/prednisolone administered orally. |
Drug: Abiraterone
Administered orally.
Drug: Prednisone or Prednisolone
Administered orally.
Drug: Placebo for Abemaciclib
Administered orally.
|
Outcome Measures
Primary Outcome Measures
- Radiographic Progression-Free Survival (rPFS) Assessed by Investigator [Randomization to radiographic progression or death from any cause (approximately 48 months)]
rPFS Assessed by Investigator
Secondary Outcome Measures
- rPFS Assessed by Blinded Independent Central Review (BICR) [Randomization to radiographic progression or death from any cause (approximately 48 months)]
rPFS Assessed by BICR
- Castration-resistant Prostate Cancer (CRPC)-free Survival [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)]
CRPC-free Survival
- Overall Survival (OS) [Baseline to date of death due to any cause (approximately 60 months)]
OS
- Time to Pain Progression [Randomization to pain progression (approximately 48 months)]
Measured by a combination of 2 scales, the Brief Pain Inventory Short Form (BPI-SF) Worst Pain Numeric Rating Scale (NRS) and the Analgesic Quantification Algorithm (AQA) scale. The BPI-SF Worst Pain NRS is a self-reported 11-item questionnaire on worst pain intensity on the past 24 hours. Score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). The AQA scores analgesic use from 0 (minimum) to 7 (maximum).
- Time to Deterioration in Health-Related Quality of Life (HRQoL) [Randomization to the date of HRQoL deterioration (approximately 48 Months)]
Measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P; Physical well-being and Prostate Cancer Subscale). The FACT-P is a 39-item self-reported questionnaire that assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life.
- Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib [Postdose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)]
PK: Mean steady state exposure of abemaciclib
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Adenocarcinoma of the prostate.
-
High-risk metastatic disease defined as:
-
Greater than or equal to (≥)4 bone metastases and/or
-
≥1 visceral metastases
-
Androgen deprivation therapy (either medical with a luteinizing hormone-releasing hormone [LHRH] analogue or surgical castration) must have been started prior to randomization and continued throughout the study.
-
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 &
- inhibitor
-
Development of metastatic prostate cancer in the context of castrate levels of testosterone (≤50 ng/dL)
-
Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), the following exceptions are permitted:
-
Up to 3 months of androgen deprivation therapy (ADT) (when given without docetaxel) AND absence of radiographic or prostate specific antigen (PSA) progression prior to randomization
-
Up to 6 cycles of docetaxel with ADT AND absence of radiographic or PSA progression prior to randomization
-
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. Patients with a history of treated brain metastases are eligible provided that disease is stable following treatment for at least 8 weeks prior to randomization and no requirement for corticosteroid use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35249 |
| 2 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
| 3 | St. Joseph's Hospital and Medical Center | Phoenix | Arizona | United States | 85004 |
| 4 | USO - Arizona Oncology Associates - HAL | Prescott Valley | Arizona | United States | 86314 |
| 5 | The University of Arizona Cancer Center - North Campus | Tucson | Arizona | United States | 85719 |
| 6 | Genesis Cancer Center | Hot Springs | Arkansas | United States | 71913 |
| 7 | St. Bernards Medical Center | Jonesboro | Arkansas | United States | 72401 |
| 8 | Highlands Oncology Group | Springdale | Arkansas | United States | 72762 |
| 9 | Orange Coast Memorial Medical Center | Fountain Valley | California | United States | 92708 |
| 10 | Providence Medical Foundation | Fullerton | California | United States | 92835 |
| 11 | Moores Cancer Center | La Jolla | California | United States | 92093 |
| 12 | MemorialCare Health System - Long Beach Medical Center | Long Beach | California | United States | 90806 |
| 13 | Cancer and Blood Specialty Clinic | Los Alamitos | California | United States | 90720 |
| 14 | TRIO-US (Translational Research in Oncology-US) | Los Angeles | California | United States | 90024 |
| 15 | UCLA Hematology/Oncology - Santa Monica | Los Angeles | California | United States | 90404 |
| 16 | Torrance Memorial Physician Network / Cancer Care | Torrance | California | United States | 90505 |
| 17 | PIH Health Hematology Medical Oncology | Whittier | California | United States | 90602 |
| 18 | University of Colorado Anschutz Medical Campus | Aurora | Colorado | United States | 80045 |
| 19 | UCHealth Memorial Hospital | Colorado Springs | Colorado | United States | 80909 |
| 20 | University of Colorado Health - Harmony | Fort Collins | Colorado | United States | 80528 |
| 21 | Colorado West Healthcare System | Grand Junction | Colorado | United States | 81505 |
| 22 | Rocky Mountain Cancer Center | Littleton | Colorado | United States | 80120 |
| 23 | Medical Oncology Hematology Consultants, PA | Newark | Delaware | United States | 19713 |
| 24 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33901 |
| 25 | Memorial Regional Hospital | Hollywood | Florida | United States | 33021 |
| 26 | Millennium Oncology Research Clinic | Hollywood | Florida | United States | 33024 |
| 27 | Florida Cancer Specialists East | West Palm Beach | Florida | United States | 33401 |
| 28 | Dwight D Eisenhower Army Medical Center | Fort Gordon | Georgia | United States | 30905 |
| 29 | Northeast Georgia Medical Center | Gainesville | Georgia | United States | 30501 |
| 30 | Central Georgia Cancer Care | Macon | Georgia | United States | 31201 |
| 31 | Candler Medical Oncology Practice - Statesboro | Savannah | Georgia | United States | 31405 |
| 32 | Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | United States | 46804 |
| 33 | The University of Louisville, James Graham Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
| 34 | Hematology Oncology Clinic | Baton Rouge | Louisiana | United States | 70809 |
| 35 | Central Maine Medical Center | Lewiston | Maine | United States | 04240 |
| 36 | New England Cancer Specialists | Scarborough | Maine | United States | 04074 |
| 37 | Chesapeake Urology | Towson | Maryland | United States | 21204 |
| 38 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 39 | Reliant Medical Group | Worcester | Massachusetts | United States | 01606 |
| 40 | University of Massachusetts Medical School | Worcester | Massachusetts | United States | 01655 |
| 41 | Minnesota Oncology/Hematology PA | Minneapolis | Minnesota | United States | 55404 |
| 42 | Care Access - Clifton | Clifton | New Jersey | United States | 07013 |
| 43 | Summit Medical Group Cancer Center | Florham Park | New Jersey | United States | 07932 |
| 44 | Maimonides Cancer Center | Brooklyn | New York | United States | 11220 |
| 45 | Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Mineola | New York | United States | 11501 |
| 46 | Laura and Isaac Perlmutter Cancer Center | New York | New York | United States | 10016 |
| 47 | Associated Medical Professionals - Urology | Syracuse | New York | United States | 13210 |
| 48 | TriState Urologic Services DBA TUG Research | Cincinnati | Ohio | United States | 45212 |
| 49 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 50 | Northwest Cancer Specialists PC | Tigard | Oregon | United States | 97223 |
| 51 | AHN Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 52 | Tennessee Oncology Chattanooga-SCRI | Chattanooga | Tennessee | United States | 37404 |
| 53 | University of Tennessee Medical Center | Knoxville | Tennessee | United States | 37920 |
| 54 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
| 55 | Texas Oncology Cancer Center | Austin | Texas | United States | 78731 |
| 56 | Texas Oncology - Carrollton | Carrollton | Texas | United States | 75010 |
| 57 | Parkland Health and Hospital System | Dallas | Texas | United States | 75235 |
| 58 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390-8884 |
| 59 | The Center for Cancer and Blood Disorders | Fort Worth | Texas | United States | 76104 |
| 60 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
| 61 | Texas Oncology - Longview Cancer Center | Longview | Texas | United States | 75601 |
| 62 | Urology San Antonio Research | San Antonio | Texas | United States | 78229 |
| 63 | US Oncology | The Woodlands | Texas | United States | 77380 |
| 64 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112 |
| 65 | The University of Vermont Medical Center Inc. | Burlington | Vermont | United States | 05405 |
| 66 | Oncology and Hematology Associates of Southwest Virginia Inc | Roanoke | Virginia | United States | 24014 |
| 67 | Centro de Investigaciones Metabólicas (CINME) | Ciudad Autónoma de Buenos Aire | Buenos Aires | Argentina | C1027AAP |
| 68 | Instituto de Investigaciones Clínicas Mar del Plata | Mar del Plata | Buenos Aires | Argentina | 7600 |
| 69 | Fundación Cenit Para La Investigación En Neurociencias | Caba | Ciudad Autónoma De Buenos Aire | Argentina | 1125 |
| 70 | Centro Medico Privado CEMAIC | Capital | Córdoba | Argentina | X5008HHW |
| 71 | Instituto Médico Río Cuarto | Río Cuarto | Córdoba | Argentina | 5800 |
| 72 | Clinica Viedma S. A | Viedma | Río Negro | Argentina | R8500ACE |
| 73 | Centro Medico San Roque | San Miguel de Tucumán | Tucumán | Argentina | 4000 |
| 74 | Investigaciones Clinicas Moleculares (ICM) | Buenos Aires | Argentina | 1425 | |
| 75 | Centro Oncologico Korben | Buenos Aires | Argentina | 1426 | |
| 76 | Asociación de Beneficencia Hospital Sirio Libanés | Buenos Aires | Argentina | C1419AHN | |
| 77 | Fundación Respirar | Buenos Aires | Argentina | C1426ABP | |
| 78 | Centro Urológico Profesor Bengió | Córdoba | Argentina | 5000 | |
| 79 | Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan | San Juan | Argentina | 5400 | |
| 80 | Chris O'Brien Lifehouse | Camperdown | New South Wales | Australia | 2050 |
| 81 | Coffs Harbour Health Campus | Coffs Harbour | New South Wales | Australia | 2450 |
| 82 | St Vincent's Hospital | Darlinghurst | New South Wales | Australia | 2010 |
| 83 | Liverpool Hospital | Liverpool | New South Wales | Australia | 2170 |
| 84 | Macquarie University | Macquarie University | New South Wales | Australia | 2109 |
| 85 | Icon Cancer Centre South Brisbane | South Brisbane | Queensland | Australia | 4101 |
| 86 | Tasman Oncology Research | Southport | Queensland | Australia | 4215 |
| 87 | Princess Alexandra Hospital | Woolloongabba | Queensland | Australia | 4102 |
| 88 | Lyell McEwin Hospital | Elizabeth Vale | South Australia | Australia | 5112 |
| 89 | Ashford Cancer Centre Research | Kurralta Park | South Aust | Australia | 5037 |
| 90 | Icon Cancer Centre Hobart | Hobart | Tasmania | Australia | 7000 |
| 91 | Box Hill Hospital | Box Hill | Victoria | Australia | 3128 |
| 92 | Monash Health | Clayton | Victoria | Australia | 3168 |
| 93 | Epworth Freemasons | East Melbourne | Victoria | Australia | 3002 |
| 94 | Barwon Health | Geelong | Victoria | Australia | 3220 |
| 95 | Austin Health | Heidelberg | Victoria | Australia | 3084 |
| 96 | St Vincent's Hospital | Melbourne | Victoria | Australia | 3065 |
| 97 | Fiona Stanley Hospital | Murdoch | Western Australia | Australia | 6150 |
| 98 | Onze Lieve Vrouw Ziekenhuis Aalst | Aalst | Oost-Vlaanderen | Belgium | 9300 |
| 99 | UZ Gent | Gent | Oost-Vlaanderen | Belgium | 9000 |
| 100 | ZNA Jan Palfijn | Merksem | Vlaams Gewest | Belgium | 2170 |
| 101 | AZ Groeninge Campus Kennedylaan | Kortrijk | West-Vlaanderen | Belgium | 8500 |
| 102 | Centre Hospitalier Universitaire Sart Tilman | Liège | Belgium | 4000 | |
| 103 | CHU UCL Namur/Site Sainte Elisabeth | Namur | Belgium | 5000 | |
| 104 | Nucleo de Oncologia da Bahia | Salvador | Bahia | Brazil | 40170-110 |
| 105 | Centro de Pesquisa Clínica do Instituto do Câncer do Ceará | Fortaleza | Ceará | Brazil | 60430235 |
| 106 | Centro Avançado de Tratamento Oncológico- CENANTRON | Belo Horizonte | Minas Gerais | Brazil | 30130090 |
| 107 | Centro Integrado de Oncologia de Curitiba | Curitiba | Paraná | Brazil | 80810050 |
| 108 | Hospital de Cancer de Londrina | Londrina | Paraná | Brazil | 86015-520 |
| 109 | Instituto de Educação, Pesquisa e Gestão em Saúde | Rio de Janeiro | Rio De Jan | Brazil | 22775-002 |
| 110 | Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande Do Sul | Brazil | 90610-000 |
| 111 | Instituto de Oncologia Saint Gallen | Santa Cruz do Sul | Rio Grande Do Sul | Brazil | 96830-180 |
| 112 | Clínica de Oncologia Reichow | Blumenau | Santa Catarina | Brazil | 89010-340 |
| 113 | Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | Brazil | 14784400 |
| 114 | Instituto do Cancer Arnaldo Vieira de Carvalho | São Paulo | Brazil | 01209-000 | |
| 115 | Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | Brazil | 01246-000 | |
| 116 | Núcleo de Pesquisa Clínica da Rede São Camilo | São Paulo | Brazil | 04014-002 | |
| 117 | BC Cancer Vancouver | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 118 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 119 | Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
| 120 | Afflilated Hospital of Bengbu Medical College | Bengbu | Anhui | China | 233004 |
| 121 | Second Affiliated hospital of Anhui Medical University | Hefei | Anhui | China | 230000 |
| 122 | Wannan Medical College Yijishan Hospital | Wuhu | Anhui | China | 241001 |
| 123 | Beijing Hospital | Beijing | Beijing | China | 100005 |
| 124 | Peking University First Hospital | Beijing | Beijing | China | 100034 |
| 125 | Beijing Cancer hospital | Beijing | Beijing | China | 100142 |
| 126 | The First Affiliated Hospital Chongqing Medical University | Chongqing | Chongqing | China | 400016 |
| 127 | Chongqing University Cancer Hospital | Chongqing | Chongqing | China | 400030 |
| 128 | Army Medical Center of People's Liberation Army | Chongqing | Chongqing | China | 400042 |
| 129 | Gansu Cancer Hospital | Lanzhou | Gansu | China | 730050 |
| 130 | Sun Yat-Sen University Cancer Centre | Guangzhou | Guangdong | China | 510060 |
| 131 | Southern Medical University Nanfang Hospital | Guangzhou | Guangdong | China | 510515 |
| 132 | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China | 150081 |
| 133 | People's Hospital of Henan Province | Zhengzhou | Henan | China | 450003 |
| 134 | Wuhan Union Hospital | Wuhan | Hubei | China | 430022 |
| 135 | Tongji Hospital Tongji Medical,Science & Technology | Wuhan | Hubei | China | 430030 |
| 136 | Hunan Provincial People's Hospital | ChangSha | Hunan | China | 410005 |
| 137 | Xiangya Hospital Central South University | Changsha | Hunan | China | 410008 |
| 138 | Hunan Cancer Hospital | Changsha | Hunan | China | 410013 |
| 139 | Jiangsu provincial people's hospital | Nanjing | Jiangsu | China | 210029 |
| 140 | Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | China | 225001 |
| 141 | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | 330006 |
| 142 | The First Hospital of Jilin University | Changchun | Jilin | China | 130021 |
| 143 | Jilin Cancer Hospital | Changchun | Jilin | China | 132000 |
| 144 | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China | 710061 |
| 145 | Yantai Yuhuangding Hospital | Yantai | Shandong | China | 264099 |
| 146 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200032 |
| 147 | Huadong Hospital Affiliated to Fudan University | Shanghai | Shanghai | China | 200040 |
| 148 | Shanghai Tenth People's Hospital | Shanghai | Shanghai | China | 200072 |
| 149 | Shanghai General Hospital | Shanghai | Shanghai | China | 200080 |
| 150 | West China Hospital of Sichuan University | Cheng Du | Sichuan | China | 610041 |
| 151 | Nanchong Central Hospital | Nanchong | Sichuan | China | 637000 |
| 152 | The Second Hospital of Tianjin Medical University | Tianjin | Tianjin | China | 300211 |
| 153 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin | China | |
| 154 | The First Affiliated Hospital of Xinjiang Medical University | Urumchi | Xinjiang | China | 830054 |
| 155 | Xinjiang Medical University Cancer Hospital - Urumqi | Urumqi | Xinjiang | China | 830000 |
| 156 | The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
| 157 | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China | 310014 |
| 158 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310022 |
| 159 | Ningbo First Hospital | Ningbo | Zhejiang | China | 315010 |
| 160 | Nemocnice Horovice | Horovice | Beroun | Czechia | 268 31 |
| 161 | Masarykuv onkologicky ustav | Brno | Brno-město | Czechia | 656 53 |
| 162 | Fakultni Nemocnice u sv. Anny v Brne | Brno | Brno-město | Czechia | 656 91 |
| 163 | Fakultni nemocnice Kralovske Vinohrady | PRague | Praha 10 | Czechia | 10034 |
| 164 | Thomayerova nemocnice | Prague | Praha 4 | Czechia | 14059 |
| 165 | Oblastní nemocnice Příbram, a.s. | Pribram | Příbram | Czechia | 261 01 |
| 166 | Nemocnice Chomutov | Chomutov | Czechia | 430 01 | |
| 167 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | 500 05 | |
| 168 | Urocentrum Praha | Prague | Czechia | 120 00 | |
| 169 | Rigshospitalet | Copenhagen | Hovedstade | Denmark | 2100 |
| 170 | Herlev and Gentofte Hospital | Copenhagen | Hovedstade | Denmark | 2730 |
| 171 | Næstved Sygehus | Næstved | Sjælland | Denmark | 4700 |
| 172 | Vejle Sygehus | Vejle | Syddanmark | Denmark | 7100 |
| 173 | Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan | Brest | Bretagne | France | 29200 |
| 174 | Polyclinique De Blois | La Chaussée-Saint-Victor | Centre | France | 41260 |
| 175 | Centre Georges François Leclerc | Dijon | Côte-d'Or | France | 21079 |
| 176 | CHU Besançon | Besançon | Doubs | France | 25000 |
| 177 | Centre de Cancérologie du Grand Montpellier | Montpellier | Languedoc-Roussillon | France | 34070 |
| 178 | Hôpital privé du Confluent SAS | Nantes | Loire-Atlantique | France | 44277 |
| 179 | Institut de Cancérologie de l'Ouest | Saint Herblain | Loire-Atlantique | France | 44805 |
| 180 | Clinique Victor Hugo Le Mans | Le Mans | Pays-de-la-Loire | France | 72000 |
| 181 | Institut Paoli-Calmettes | Marseille | Provence-Alpes-Côte-d'Azur | France | 13273 |
| 182 | Centre Leon Berard | Lyon | Rhône-Alpes | France | 69008 |
| 183 | Hôpital Européen Georges Pompidou | Paris | France | 75015 | |
| 184 | Universitaetsklinikum Freiburg | Freiburg | Baden-Württemberg | Germany | 79106 |
| 185 | NCT | Heidelberg | Baden-Württemberg | Germany | 69120 |
| 186 | Studienpraxis Urologie | Nürtingen | Baden-Württemberg | Germany | 72622 |
| 187 | Universitaetsklinikum Ulm | Ulm | Baden-Württemberg | Germany | 89081 |
| 188 | Universitaetsklinikum Tuebingen | Tübingen | Baden-Würt | Germany | 72076 |
| 189 | Klinikum Rechts Der Isar Der Technischen Universität München | Munich | Bayern | Germany | 81675 |
| 190 | Universitätsklinikum Frankfurt | Frankfurt | Hessen | Germany | 60590 |
| 191 | Urologische Gemeinschaftspraxis Heinsberg | Heinsberg | Nordrhein-Westfalen | Germany | 52525 |
| 192 | Universitätsklinikum Münster - Albert Schweitzer Campus | Münster | Nordrhein-Westfalen | Germany | 48149 |
| 193 | Urologische Gemeinschaftspraxis Wesel | Wesel | Nordrhein-Westfalen | Germany | 46483 |
| 194 | Urologicum Duisburg Fachärztesozietät - Walsum | Duisburg | Nordrhein- | Germany | 47169 |
| 195 | InVO Institut für Versorgungsforschung in der Onkologie | Koblenz | Rheinland-Pfalz | Germany | 56068 |
| 196 | Universitätsmedizin Johannes Gutenberg Universität Mainz | Mainz | Rheinland-Pfalz | Germany | 55131 |
| 197 | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany | 20246 | |
| 198 | Urologie Neandertal - Praxis Mettmann | Mettmann | Germany | 40822 | |
| 199 | Klinikum Nürnberg Nord | Nürnberg | Germany | 90419 | |
| 200 | University Hospital of Patras | Patras | Achaḯa | Greece | 26504 |
| 201 | Agios Savvas Regional Cancer Hospital | Athens | Attikí | Greece | 115 22 |
| 202 | Alexandra General Hospital of Athens | Athens | Attikí | Greece | 115 28 |
| 203 | Attikon General University Hospital | Chaidari | Attikí | Greece | 12462 |
| 204 | University General Hospital of Heraklion | Heraklion | Irakleío | Greece | 711 10 |
| 205 | Bacs-Kiskun Megyei Korhaz | Kecskemét | Bács-Kiskun | Hungary | 6000 |
| 206 | Petz Aladar Egyetemi Oktato Korhaz | Gyor | Győr-Moson-Sopron | Hungary | 9024 |
| 207 | Országos Onkológiai Intézet | Budapest | Pest | Hungary | 1122 |
| 208 | Zala Megyei Szent Rafael Kórház | Zalaegerszeg | Zala | Hungary | 8900 |
| 209 | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | Hungary | 1062 | |
| 210 | Dél-Pesti Centrumkórház | Budapest | Hungary | 1097 | |
| 211 | Meir Medical Center | Kfar Saba | HaMerkaz | Israel | 4428164 |
| 212 | Rabin Medical Center | Petah Tikva | HaMerkaz | Israel | 4941492 |
| 213 | Sheba Medical Center | Ramat Gan | HaMerkaz | Israel | 5265601 |
| 214 | Yitzhak Shamir Medical Center | Zerifin | HaMerkaz | Israel | 70300 |
| 215 | Rambam Health Care Campus | Haifa | HaTsafon | Israel | 3109601 |
| 216 | Sourasky Medical Center | Tel Aviv | Tell Abīb | Israel | 6423906 |
| 217 | Hadassah Medical Center | Jerusalem | Yerushalayim | Israel | 9112001 |
| 218 | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | Emilia-Romagna | Italy | 47014 |
| 219 | Fondazione Policlinico Universitario Agostino Gemelli | Roma | Lazio | Italy | 00168 |
| 220 | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardia | Italy | 20133 |
| 221 | Istituto Oncologico Veneto IRCCS | Castelfranco Veneto | Veneto | Italy | 31033 |
| 222 | Istituto Europeo di Oncologia IRCCS | Milano | Italy | 20141 | |
| 223 | Azienda Ospedaliera Santa Maria Terni | Terni | Italy | 05100 | |
| 224 | APSS- Presidio Ospedaliero S. Chiara | Trento | Italy | 38122 | |
| 225 | Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital | Nagoya | Aichi | Japan | 466-8650 |
| 226 | National Cancer Center Hospital East | Kashiwa | Chiba | Japan | 277-8577 |
| 227 | Kimitsu Chuo Hospital | Kisarazu | Chiba | Japan | 292-8535 |
| 228 | Toho University Sakura Medical Center | Sakura | Chiba | Japan | 285-8741 |
| 229 | Hokkaido University Hospital | Sapporo | Hokkaido | Japan | 060-8648 |
| 230 | Kobe City Medical Center General Hospital | Kobe | Hyogo | Japan | 650-0047 |
| 231 | Kanazawa University Hospital | Kanazawa | Ishikawa | Japan | 920-8641 |
| 232 | Kagawa University Hospital | Kita | Kagawa | Japan | 761-0701 |
| 233 | Yokohama City University Medical Center | Yokohama | Kanagawa | Japan | 232-0024 |
| 234 | Nagano Municipal Hospital | Tomitake | Nagano | Japan | 381-8551 |
| 235 | Hamamatsu University School of Medicine University Hospital | Hamamatsu | Shizuoka | Japan | 431-3192 |
| 236 | Showa University Hospital | Shinagawa | Tokyo | Japan | 142-8555 |
| 237 | National Hospital Organization Kumamoto Medical Center | Kumamoto | Japan | 860-0008 | |
| 238 | Osaka International Cancer Institute | Osaka | Japan | 541-8567 | |
| 239 | Osaka City University Hospital | Osaka | Japan | 545-8586 | |
| 240 | Severance Hospital, Yonsei University Health System | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 03722 |
| 241 | Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 05505 |
| 242 | Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 06351 |
| 243 | Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | Korea, Republic of | 3080 |
| 244 | Health Pharma Professional Research S.A. de C.V: | Ciudad de México | Distrito Federal | Mexico | 03100 |
| 245 | Actualidad Basada en la Investigación del Cáncer | Guadalajara | Jalisco | Mexico | 44680 |
| 246 | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | Mexico | 64460 |
| 247 | Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C. | Culiacan | Sinaloa | Mexico | 80230 |
| 248 | Scientia Investigacion Clinica S.C. | Chihuahua | Mexico | 31203 | |
| 249 | Centro de Investigacion Clinica de Oaxaca | Oaxaca | Mexico | 68020 | |
| 250 | Canisius-Wilhelmina Ziekenhuis | Nijmegen | Gelderland | Netherlands | 6532 SZ |
| 251 | ETZ Elisabeth | Tilburg | Noord-Brabant | Netherlands | 5022 GC |
| 252 | University Medical Center Groningen | Groningen | Netherlands | 9713 GZ | |
| 253 | St. Antonius Ziekenhuis, locatie Utrecht | Utrecht | Netherlands | 3543 AZ | |
| 254 | Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii | Wroclaw | Dolnośląskie | Poland | 53-413 |
| 255 | Clinical Best Solutions | Lublin | Lubelskie | Poland | 20-078 |
| 256 | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie | Warszawa | Mazowieckie | Poland | 02-781 |
| 257 | Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego | Opole | Opolskie | Poland | 45-061 |
| 258 | Szpitale Pomorskie Sp. z o. o. | Gdynia | Pomorskie | Poland | 81-519 |
| 259 | Wielkopolskie Centrum Onkologii | Poznan | Wielkopolskie | Poland | 61-866 |
| 260 | Salve Medica | Lodz | Łódzkie | Poland | 91-211 |
| 261 | Provita Profamilia | Piotrkow Trybunalski | Łódzkie | Poland | 97-300 |
| 262 | C.M.D.T.A. Neomed | Brasov | Brașov | Romania | 500283 |
| 263 | Amethyst Radiotherapy Center | Florești | Cluj | Romania | 407280 |
| 264 | Constanta County Emergency Clinical Hospital Sf.Ap.Andrei | Constanta | Constanța | Romania | 900591 |
| 265 | Centrul de Oncologie "Sfântul Nectarie" | Craiova | Dolj | Romania | 200542 |
| 266 | Radiology Therapeutic Center | Otopeni | Ilfov | Romania | 075100 |
| 267 | Oncopremium Team | Baia Mare | Maramureș | Romania | 430291 |
| 268 | Centrul medical Focus | București | Romania | 021397 | |
| 269 | Gral Medical SRL | București | Romania | 031422 | |
| 270 | Instituto Catalan de Oncologia - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Catalunya [Cataluña] | Spain | 8907 |
| 271 | Hospital General Universitario Gregorio Marañon | Madrid | Madrid, Comunidad De | Spain | 28009 |
| 272 | Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad De | Spain | 28034 |
| 273 | Hospital Universitario 12 de Octubre | Madrid | Madrid, Comunidad De | Spain | 28041 |
| 274 | Fundación Instituto Valenciano de Oncología | Valencia | Valenciana, Comunitat | Spain | 46009 |
| 275 | Hospital Infanta Cristina | Badajoz | Spain | 06006 | |
| 276 | Hospital Universitario Virgen Del Rocio | Sevilla | Spain | 41013 | |
| 277 | Taichung Veterans General Hospital | Taichung City | Taichung | Taiwan | 40705 |
| 278 | National Taiwan University Hospital | Taipei City | Taipei | Taiwan | 10055 |
| 279 | Taipei Veterans General Hospital | Taipei City | Taipei | Taiwan | 112 |
| 280 | China Medical University Hospital | Taichung | Taiwan | 404332 | |
| 281 | National Cheng-Kung Uni. Hosp. | Tainan | Taiwan | 704 | |
| 282 | Chang Gung Medical Foundation-Linkou Branch | Taoyuan | Taiwan | 333 | |
| 283 | Medipol Mega Universite Hastanesi | Stanbul | İstanbul | Turkey | 34214 |
| 284 | Izmir Medical Park Hospital | Izmir, Karsiyaka | İzmir | Turkey | 009035575 |
| 285 | Baskent University Dr. Turgut Noyan Research and Training Center | Adana | Turkey | 01250 | |
| 286 | Ankara City Hospital | Ankara | Turkey | 06800 | |
| 287 | Ankara Universitesi Tip Fakultesi Hastanesi | Ankara | Turkey | ||
| 288 | Dicle Üniversitesi | Diyarbakir | Turkey | 21200 | |
| 289 | Trakya University | Edirne | Turkey | 22030 | |
| 290 | TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi | Istanbul | Turkey | 34722 | |
| 291 | İnönü Üniversitesi Turgut Özal Tıp Merkezi | Malatya | Turkey | 44280 | |
| 292 | Royal Blackburn Hospital | Blackburn | Blackburn With Darwen | United Kingdom | BB2 3HH |
| 293 | Colchester General Hospital | Colchester | Essex | United Kingdom | CO4 5JL |
| 294 | Charing Cross Hospital | London | Hammersmith And Fulham | United Kingdom | W6 8RF |
| 295 | University College London Hospital | London | London, City Of | United Kingdom | NW1 2PG |
| 296 | Panthera@theRutherford - South Wales | Newport | Newport [Casnewydd Gb-cnw] | United Kingdom | NP10 8FZ |
| 297 | Panthera@theRutherford - North East | Bedlington | Northumberland | United Kingdom | NE22 7FD |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05288166
Other Study ID Numbers:
- 18448
- I3Y-MC-JPEG
- 2022-500461-28
First Posted:
Mar 21, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms: