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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) (CYCLONE 3)

Primary Purpose

Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abemaciclib
Abiraterone
Prednisone or Prednisolone
Placebo for Abemaciclib
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 & 6) 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

Sites / Locations

  • The University of Arizona Cancer Center - North CampusRecruiting
  • Genesis Cancer and Blood InstituteRecruiting
  • St. Bernards Medical CenterRecruiting
  • Orange Coast Memorial Medical CenterRecruiting
  • Providence Medical FoundationRecruiting
  • Moores Cancer CenterRecruiting
  • MemorialCare Health System - Long Beach Medical CenterRecruiting
  • Cancer and Blood Specialty ClinicRecruiting
  • UCLA Hematology/Oncology - Santa MonicaRecruiting
  • TRIO-US (Translational Research in Oncology-US)Recruiting
  • Torrance Memorial Physician Network / Cancer CareRecruiting
  • PIH Health Hematology Medical OncologyRecruiting
  • University of Colorado Anschutz Medical Campus
  • UCHealth Memorial HospitalRecruiting
  • University of Colorado Health - Harmony
  • Rocky Mountain Cancer CenterRecruiting
  • Florida Cancer Specialists - SouthRecruiting
  • Memorial Regional HospitalRecruiting
  • Millennium Oncology - HollywoodRecruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer CenterRecruiting
  • Florida Cancer Specialist- EastRecruiting
  • Dwight D Eisenhower Army Medical CenterRecruiting
  • Northeast Georgia Medical CenterRecruiting
  • Central Georgia Cancer CareRecruiting
  • Fort Wayne Medical Oncology and HematologyRecruiting
  • The University of Louisville, James Graham Brown Cancer CenterRecruiting
  • Central Maine Medical CenterRecruiting
  • Chesapeake UrologyRecruiting
  • Massachusetts General HospitalRecruiting
  • Reliant Medical GroupRecruiting
  • University of Massachusetts Medical SchoolRecruiting
  • Minnesota Oncology/Hematology PARecruiting
  • Care Access - CliftonRecruiting
  • Maimonides Cancer CenterRecruiting
  • Clinical Research AllianceRecruiting
  • Perlmutter Cancer Center at NYU Langone Hospital - Long IslandRecruiting
  • Laura and Isaac Perlmutter Cancer CenterRecruiting
  • Associated Medical Professionals - UrologyRecruiting
  • TriState Urologic Services PSC Inc.Recruiting
  • MidLantic urologyRecruiting
  • AHN Allegheny General HospitalRecruiting
  • University of Tennessee Medical CenterRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • Texas Oncology - BalconesRecruiting
  • Parkland Health and Hospital SystemRecruiting
  • UT Southwestern Medical CenterRecruiting
  • The Center for Cancer and Blood Disorders
  • Houston Methodist HospitalRecruiting
  • Urology San Antonio Research
  • USO - Texas Oncology Gulf CoastRecruiting
  • Baylor Scott & White Medical Center - TempleRecruiting
  • Huntsman Cancer InstituteRecruiting
  • The University of Vermont Medical Center Inc.Recruiting
  • Oncology and Hematology Associates of Southwest Virginia IncRecruiting
  • Instituto de Investigaciones Clínicas Mar del Plata
  • Asociación de Beneficencia Hospital Sirio Libanés
  • Centro de Investigaciones Metabólicas (CINME)Recruiting
  • Investigaciones Clinicas Moleculares (ICM)
  • Fundación Cenit Para La Investigación En Neurociencias
  • Centro Medico Privado CEMAIC
  • Instituto Médico Río Cuarto
  • Clinica Viedma
  • Centro Medico San Roque
  • Centro Oncologico Korben
  • Fundación Respirar
  • Centro Urológico Profesor Bengió
  • CER San Juan
  • Chris O'Brien LifehouseRecruiting
  • Coffs Harbour Health CampusRecruiting
  • St Vincent's HospitalRecruiting
  • Liverpool HospitalRecruiting
  • Macquarie UniversityRecruiting
  • Icon Cancer Centre South BrisbaneRecruiting
  • Tasman Oncology ResearchRecruiting
  • Lyell McEwin Hospital
  • Ashford Cancer Centre Research
  • Icon Cancer Centre Hobart
  • Box Hill Hospital
  • Monash HealthRecruiting
  • Epworth Freemasons
  • Barwon HealthRecruiting
  • Onze Lieve Vrouw Ziekenhuis AalstRecruiting
  • UZ GentRecruiting
  • AZ Groeninge Campus KennedylaanRecruiting
  • CHU UCL Namur/Site Sainte ElisabethRecruiting
  • Nucleo de Oncologia da Bahia
  • Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
  • Centro Avançado de Tratamento Oncológico- CENANTRON
  • Centro Integrado de Oncologia de Curitiba
  • Hospital de Cancer de Londrina
  • Instituto de Educação, Pesquisa e Gestão em Saúde
  • Hospital São Lucas da PUCRS
  • Instituto de Oncologia Saint Gallen
  • Clínica de Oncologia Reichow
  • Fundação Pio XII - Hospital de Câncer de Barretos
  • Instituto do Cancer Arnaldo Vieira de Carvalho
  • Icesp - Instituto Do Câncer Do Estado de São Paulo
  • Núcleo de Pesquisa Clínica da Rede São Camilo
  • Afflilated Hospital of Bengbu Medical College
  • Second Affiliated hospital of Anhui Medical University
  • Wannan Medical College Yijishan Hospital
  • Peking University First Hospital
  • Beijing Cancer hospital
  • Sun Yat-Sen University Cancer Centre
  • Southern Medical University Nanfang HospitalRecruiting
  • Harbin Medical University Cancer Hospital
  • Wuhan Union Hospital
  • Tongji Hospital Tongji Medical,Science & Technology
  • Hunan Provincial People's Hospital
  • Xiangya Hospital Central South UniversityRecruiting
  • Hunan Cancer Hospital
  • Northern Jiangsu People's Hospital
  • The First Affiliated Hospital of Nanchang University
  • Jilin Cancer Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Fudan University Shanghai Cancer Center
  • Huadong Hospital Affiliated to Fudan UniversityRecruiting
  • Shanghai Tenth People's Hospital
  • Shanghai General HospitalRecruiting
  • West China Hospital of Sichuan University
  • Nanchong Central Hospital
  • The Second Hospital of Tianjin Medical UniversityRecruiting
  • Tianjin Medical University Cancer Institute and Hospital
  • The First Affiliated Hospital, Zhejiang University
  • Zhejiang Provincial People's Hospital
  • Zhejiang Cancer HospitalRecruiting
  • Ningbo First Hospital
  • Nemocnice HoroviceRecruiting
  • Masarykuv onkologicky ustav
  • Fakultni Nemocnice u sv. Anny v Brne
  • Fakultni nemocnice Kralovske VinohradyRecruiting
  • Fakultni nemocnice Hradec Kralove
  • Urocentrum Praha
  • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
  • Polyclinique De Blois
  • Centre Georges François Leclerc
  • CHU BesançonRecruiting
  • Centre de Cancérologie du Grand Montpellier
  • Hôpital privé du Confluent SASRecruiting
  • Clinique Victor Hugo Le Mans
  • Institut Paoli-CalmettesRecruiting
  • Centre Leon Berard
  • Hôpital Européen Georges PompidouRecruiting
  • Universitaetsklinikum Freiburg
  • NCT
  • Studienpraxis Urologie
  • Universitaetsklinikum Tuebingen
  • Urologische Gemeinschaftspraxis Heinsberg
  • Universitätsklinikum Münster - Albert Schweitzer Campus
  • Urologische Gemeinschaftspraxis WeselRecruiting
  • Urologicum Duisburg Fachärztesozietät - Walsum
  • InVO Institut für Versorgungsforschung in der Onkologie
  • Universitätsmedizin Johannes Gutenberg Universität Mainz
  • Universitaetsklinikum Hamburg-Eppendorf
  • Urologie Neandertal - Praxis Mettmann
  • Klinikum Nürnberg Nord
  • University Hospital of PatrasRecruiting
  • Agios Savvas Regional Cancer HospitalRecruiting
  • Alexandra HospitalRecruiting
  • Attikon General University HospitalRecruiting
  • University General Hospital of HeraklionRecruiting
  • Onkoradiologiai Kozpont
  • Petz Aladar Egyetemi Oktato Korhaz
  • Országos Onkológiai Intézet
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Rabin Medical CenterRecruiting
  • Yitzhak Shamir Medical CenterRecruiting
  • Rambam Health Care CampusRecruiting
  • Sourasky Medical CenterRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Oncologico Veneto IRCCS
  • Istituto Europeo di Oncologia IRCCS
  • Azienda Ospedaliera Santa Maria Terni
  • APSS- Presidio Ospedaliero S. Chiara
  • Japanese Red Cross Nagoya Daini HospitalRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Kimitsu Chuo HospitalRecruiting
  • Toho University Sakura Medical CenterRecruiting
  • Hokkaido University HospitalRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • Kagawa University HospitalRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Hamamatsu University HospitalRecruiting
  • Showa University HospitalRecruiting
  • National Hospital Organization Kumamoto Medical CenterRecruiting
  • Osaka International Cancer InstituteRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Health Pharma Professional Research S.A. de C.V:Recruiting
  • Actualidad Basada en la Investigación del CáncerRecruiting
  • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.Recruiting
  • Scientia Investigacion Clinica S.C.Recruiting
  • Centro de Investigacion Clinica de OaxacaRecruiting
  • ETZ Elisabeth
  • University Medical Center Groningen
  • St. Antonius Ziekenhuis, locatie UtrechtRecruiting
  • Clinical Best Solutions
  • Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
  • Szpitale Pomorskie Sp. z o. o.
  • Wielkopolskie Centrum Onkologii
  • Salve Medica
  • Provita Profamilia
  • C.M.D.T.A. Neomed
  • Amethyst Radiotherapy Center
  • Centrul de Oncologie "Sfântul Nectarie"Recruiting
  • Radiology Therapeutic CenterRecruiting
  • Oncopremium TeamRecruiting
  • Centrul medical Focus
  • Gral Medical Diagnostic CenterRecruiting
  • Instituto Catalan de Oncologia - Hospital Duran i ReynalsRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Fundación Instituto Valenciano de OncologíaRecruiting
  • Hospital Infanta CristinaRecruiting
  • Hospital Universitario Virgen Del RocioRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Chang Gung Medical Foundation-Linkou BranchRecruiting
  • Medipol Mega Universite HastanesiRecruiting
  • Izmir Medical Park HospitalRecruiting
  • Ankara Universitesi Tip Fakultesi HastanesiRecruiting
  • Dicle ÜniversitesiRecruiting
  • Trakya UniversityRecruiting
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir HastanesiRecruiting
  • İnönü Üniversitesi Turgut Özal Tıp MerkeziRecruiting
  • Royal Blackburn Hospital
  • Colchester General Hospital
  • University College London Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Abemaciclib + Abiraterone + Prednisone/Prednisolone

Placebo + Abiraterone + Prednisone/Prednisolone

Arm Description

Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.

Placebo + abiraterone + prednisone/prednisolone administered orally.

Outcomes

Primary Outcome Measures

Radiographic Progression-Free Survival (rPFS) Assessed by Investigator
rPFS Assessed by Investigator

Secondary Outcome Measures

rPFS Assessed by Blinded Independent Central Review (BICR)
rPFS Assessed by BICR
Castration-resistant Prostate Cancer (CRPC)-free Survival
CRPC-free Survival
Overall Survival (OS)
OS
Time to Pain Progression
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)
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
PK: Mean steady state exposure of abemaciclib

Full Information

First Posted
March 10, 2022
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05288166
Brief Title
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)
Acronym
CYCLONE 3
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

2. Study Status

Record Verification Date
October 7, 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abemaciclib + Abiraterone + Prednisone/Prednisolone
Arm Type
Experimental
Arm Description
Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.
Arm Title
Placebo + Abiraterone + Prednisone/Prednisolone
Arm Type
Active Comparator
Arm Description
Placebo + abiraterone + prednisone/prednisolone administered orally.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
LY2835219
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Abiraterone
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Prednisone or Prednisolone
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo for Abemaciclib
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Radiographic Progression-Free Survival (rPFS) Assessed by Investigator
Description
rPFS Assessed by Investigator
Time Frame
Randomization to radiographic progression or death from any cause (approximately 48 months)
Secondary Outcome Measure Information:
Title
rPFS Assessed by Blinded Independent Central Review (BICR)
Description
rPFS Assessed by BICR
Time Frame
Randomization to radiographic progression or death from any cause (approximately 48 months)
Title
Castration-resistant Prostate Cancer (CRPC)-free Survival
Description
CRPC-free Survival
Time Frame
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)
Title
Overall Survival (OS)
Description
OS
Time Frame
Baseline to date of death due to any cause (approximately 60 months)
Title
Time to Pain Progression
Description
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 Frame
Randomization to pain progression (approximately 48 months)
Title
Time to Deterioration in Health-Related Quality of Life (HRQoL)
Description
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.
Time Frame
Randomization to the date of HRQoL deterioration (approximately 48 Months)
Title
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib
Description
PK: Mean steady state exposure of abemaciclib
Time Frame
Postdose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
The University of Arizona Cancer Center - North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Recio Boiles
Facility Name
Genesis Cancer and Blood Institute
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Divers
Facility Name
St. Bernards Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
870-207-8177
First Name & Middle Initial & Last Name & Degree
Mazen Khalil
Facility Name
Orange Coast Memorial Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
510-673-1293
First Name & Middle Initial & Last Name & Degree
Amol Rao
Facility Name
Providence Medical Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
714-446-5900
First Name & Middle Initial & Last Name & Degree
Sanjay Sharma
Facility Name
Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
858-822-6185
First Name & Middle Initial & Last Name & Degree
Rana McKay
Facility Name
MemorialCare Health System - Long Beach Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
562-933-1877
First Name & Middle Initial & Last Name & Degree
Milan Sheth
Facility Name
Cancer and Blood Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vu Quang Phan
Facility Name
UCLA Hematology/Oncology - Santa Monica
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-794-8027
First Name & Middle Initial & Last Name & Degree
John Shen
Facility Name
TRIO-US (Translational Research in Oncology-US)
City
Los Angeles
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Williams
Facility Name
Torrance Memorial Physician Network / Cancer Care
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-750-3300
First Name & Middle Initial & Last Name & Degree
Hugo Hool
Facility Name
PIH Health Hematology Medical Oncology
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
562-789-5480
First Name & Middle Initial & Last Name & Degree
Lisa Wang
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UCHealth Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert J Hoyer
Facility Name
University of Colorado Health - Harmony
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rocky Mountain Cancer Center
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
303-730-4700
First Name & Middle Initial & Last Name & Degree
Manojkumar Bupathi
Facility Name
Florida Cancer Specialists - South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
239-274-9930
First Name & Middle Initial & Last Name & Degree
Elizabeth Guancial
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-265-4325
First Name & Middle Initial & Last Name & Degree
Atif M. Hussein
Facility Name
Millennium Oncology - Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-450-1808
First Name & Middle Initial & Last Name & Degree
Isaac Levy
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-243-1543
First Name & Middle Initial & Last Name & Degree
Marijo Bilusic
Facility Name
Florida Cancer Specialist- East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BARRY BERMAN
Facility Name
Dwight D Eisenhower Army Medical Center
City
Fort Gordon
State/Province
Georgia
ZIP/Postal Code
30905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
706-787-2100
First Name & Middle Initial & Last Name & Degree
Ryan T Oleszewski
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Nash
Facility Name
Central Georgia Cancer Care
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
478-336-5708
First Name & Middle Initial & Last Name & Degree
Bradley T. Sumrall
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Babu
Facility Name
The University of Louisville, James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Kumar
Facility Name
Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel C. Rausch
Facility Name
Chesapeake Urology
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald F Tutrone
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Raymond Smith
Facility Name
Reliant Medical Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley A. Switzer
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kriti Mittal
Facility Name
Minnesota Oncology/Hematology PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
612-884-6300
First Name & Middle Initial & Last Name & Degree
Samith T Kochuparambil
Facility Name
Care Access - Clifton
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
973-594-7977
First Name & Middle Initial & Last Name & Degree
Richards Afonja
Facility Name
Maimonides Cancer Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Becker
Facility Name
Clinical Research Alliance
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
855-737-2873
First Name & Middle Initial & Last Name & Degree
James T D'Olimpio
Facility Name
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
212-731-6366
First Name & Middle Initial & Last Name & Degree
David R Wise
Facility Name
Laura and Isaac Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
212-731-6366
First Name & Middle Initial & Last Name & Degree
David R Wise
Facility Name
Associated Medical Professionals - Urology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
315-478-4185
First Name & Middle Initial & Last Name & Degree
Christopher Pieczonka
Facility Name
TriState Urologic Services PSC Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Jeffrey Pliskin
Facility Name
MidLantic urology
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Belkoff
Facility Name
AHN Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
4123255700
First Name & Middle Initial & Last Name & Degree
Shifeng Stefan Mao
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
865-305-8780
First Name & Middle Initial & Last Name & Degree
Saikrishna Gadde
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
999-999-9999
First Name & Middle Initial & Last Name & Degree
SMO Sarah Cannon Research Inst.
Facility Name
Texas Oncology - Balcones
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-427-9400
First Name & Middle Initial & Last Name & Degree
Jeffrey Yorio
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
214-648-4180
First Name & Middle Initial & Last Name & Degree
Tian Zhang
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8884
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
214-648-4180
First Name & Middle Initial & Last Name & Degree
Tian Zhang
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
713-441-9948
First Name & Middle Initial & Last Name & Degree
Eleni Efstathiou
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
USO - Texas Oncology Gulf Coast
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
281-277-5200
First Name & Middle Initial & Last Name & Degree
Pavel Levin
Facility Name
Baylor Scott & White Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
254-724-6183
First Name & Middle Initial & Last Name & Degree
Sherronda Henderson
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neeraj Agarwal
Facility Name
The University of Vermont Medical Center Inc.
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
802-847-8400
First Name & Middle Initial & Last Name & Degree
Steven Ades
Facility Name
Oncology and Hematology Associates of Southwest Virginia Inc
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
540-982-0237
First Name & Middle Initial & Last Name & Degree
Donald C Vile
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Asociación de Beneficencia Hospital Sirio Libanés
City
Buenos Aires
State/Province
Buenos Air
ZIP/Postal Code
C1419AHN
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Air
ZIP/Postal Code
C1027AAP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
5491130703124
First Name & Middle Initial & Last Name & Degree
Monica Rondinon
Facility Name
Investigaciones Clinicas Moleculares (ICM)
City
Buenos Aires
State/Province
Ciudad Aut
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Fundación Cenit Para La Investigación En Neurociencias
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
1125
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Centro Medico Privado CEMAIC
City
Capital
State/Province
Córdoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Instituto Médico Río Cuarto
City
Río Cuarto
State/Province
Córdoba
ZIP/Postal Code
5800
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Clinica Viedma
City
Viedma
State/Province
Río Negro
ZIP/Postal Code
R8500ACE
Country
Argentina
Individual Site Status
Completed
Facility Name
Centro Medico San Roque
City
San Miguel de Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000IAK
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Centro Oncologico Korben
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Fundación Respirar
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Centro Urológico Profesor Bengió
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
CER San Juan
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61285140142
First Name & Middle Initial & Last Name & Degree
Lisa Horvath
Facility Name
Coffs Harbour Health Campus
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Briscoe
Facility Name
St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61293555655
First Name & Middle Initial & Last Name & Degree
Anthony Michael Joshua
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
0287389744
First Name & Middle Initial & Last Name & Degree
Wei Chua
Facility Name
Macquarie University
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61421088092
First Name & Middle Initial & Last Name & Degree
Howard Paul Gurney
Facility Name
Icon Cancer Centre South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61402240196
First Name & Middle Initial & Last Name & Degree
Jeffrey Goh
Facility Name
Tasman Oncology Research
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61756132480
First Name & Middle Initial & Last Name & Degree
Andrew Hill
Facility Name
Lyell McEwin Hospital
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
State/Province
South Aust
ZIP/Postal Code
5037
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Icon Cancer Centre Hobart
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Liow
Facility Name
Epworth Freemasons
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Campbell
Facility Name
Onze Lieve Vrouw Ziekenhuis Aalst
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
003253724448
First Name & Middle Initial & Last Name & Degree
Peter Schatteman
Facility Name
UZ Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolaas Lumen
Facility Name
AZ Groeninge Campus Kennedylaan
City
Kortrijk
State/Province
West-Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Lesage
Facility Name
CHU UCL Namur/Site Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Goeminne
Facility Name
Nucleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-110
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430235
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Centro Avançado de Tratamento Oncológico- CENANTRON
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130090
Country
Brazil
Individual Site Status
Completed
Facility Name
Centro Integrado de Oncologia de Curitiba
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80810050
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Cancer de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86015-520
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Educação, Pesquisa e Gestão em Saúde
City
Rio de Janeiro
State/Province
Rio De Jan
ZIP/Postal Code
22775-002
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Oncologia Saint Gallen
City
Santa Cruz do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96830-180
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Clínica de Oncologia Reichow
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784400
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto do Cancer Arnaldo Vieira de Carvalho
City
São Paulo
ZIP/Postal Code
01209-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Icesp - Instituto Do Câncer Do Estado de São Paulo
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Afflilated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Second Affiliated hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Wannan Medical College Yijishan Hospital
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sun Yat-Sen University Cancer Centre
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Southern Medical University Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
02061641888
First Name & Middle Initial & Last Name & Degree
Wanlong Tan
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tongji Hospital Tongji Medical,Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Provincial People's Hospital
City
ChangSha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
073184327918
First Name & Middle Initial & Last Name & Degree
minfeng chen
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Huadong Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
02162483180
First Name & Middle Initial & Last Name & Degree
Zhongquan Sun
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
02136126309
First Name & Middle Initial & Last Name & Degree
Shujie Xia
Facility Name
West China Hospital of Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanchong Central Hospital
City
Nanchong
State/Province
Sichuan
ZIP/Postal Code
637000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
02288329416
First Name & Middle Initial & Last Name & Degree
Yong Wang
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
057188128276
First Name & Middle Initial & Last Name & Degree
Shaoxing Zhu
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nemocnice Horovice
City
Horovice
State/Province
Beroun
ZIP/Postal Code
268 31
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Phone
420311559825
First Name & Middle Initial & Last Name & Degree
Martin Smakal
Facility Name
Masarykuv onkologicky ustav
City
Brno
State/Province
Brno-město
ZIP/Postal Code
656 53
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni Nemocnice u sv. Anny v Brne
City
Brno
State/Province
Jihomoravský Kraj
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
PRague
State/Province
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
Phone
420267162837
First Name & Middle Initial & Last Name & Degree
Jan Dvorak
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Urocentrum Praha
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Polyclinique De Blois
City
La Chaussée-Saint-Victor
State/Province
Centre
ZIP/Postal Code
41260
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Georges François Leclerc
City
Dijon
State/Province
Côte-d'Or
ZIP/Postal Code
21079
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Besançon
City
Besançon
State/Province
Doubs
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33370632403
First Name & Middle Initial & Last Name & Degree
Tristan Maurina
Facility Name
Centre de Cancérologie du Grand Montpellier
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34070
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital privé du Confluent SAS
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44277
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude El Kouri
Facility Name
Clinique Victor Hugo Le Mans
City
Le Mans
State/Province
Pays-de-la-Loire
ZIP/Postal Code
72000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Paoli-Calmettes
City
Marseille
State/Province
Provence-Alpes-Côte-d'Azur
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwenaelle Gravis
Facility Name
Centre Leon Berard
City
Lyon
State/Province
Rhône-Alpes
ZIP/Postal Code
69008
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33156092284
First Name & Middle Initial & Last Name & Degree
Stephane Oudard
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
NCT
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Studienpraxis Urologie
City
Nürtingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72622
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitaetsklinikum Tuebingen
City
Tübingen
State/Province
Baden-Würt
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Urologische Gemeinschaftspraxis Heinsberg
City
Heinsberg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52525
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Münster - Albert Schweitzer Campus
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Urologische Gemeinschaftspraxis Wesel
City
Wesel
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46483
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
492814755590
First Name & Middle Initial & Last Name & Degree
Miguel José Garcia Schürmann
Facility Name
Urologicum Duisburg Fachärztesozietät - Walsum
City
Duisburg
State/Province
Nordrhein-
ZIP/Postal Code
47169
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
InVO Institut für Versorgungsforschung in der Onkologie
City
Koblenz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56068
Country
Germany
Individual Site Status
Completed
Facility Name
Universitätsmedizin Johannes Gutenberg Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Urologie Neandertal - Praxis Mettmann
City
Mettmann
ZIP/Postal Code
40822
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum Nürnberg Nord
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
University Hospital of Patras
City
Patras
State/Province
Achaḯa
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Phone
302610999791
First Name & Middle Initial & Last Name & Degree
Angelos Koutras
Facility Name
Agios Savvas Regional Cancer Hospital
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 22
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Phone
2106495212
First Name & Middle Initial & Last Name & Degree
George Papaxoinis
Facility Name
Alexandra Hospital
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Phone
302132162845
First Name & Middle Initial & Last Name & Degree
Michalis Liontos
Facility Name
Attikon General University Hospital
City
Chaidari
State/Province
Attikí
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Phone
302105831256
First Name & Middle Initial & Last Name & Degree
Aristotelis Bamias
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Irakleío
ZIP/Postal Code
715 00
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
Phone
2810392750
First Name & Middle Initial & Last Name & Degree
Dimitrios Mavroudis
Facility Name
Onkoradiologiai Kozpont
City
Kecskemét
State/Province
Bács-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Petz Aladar Egyetemi Oktato Korhaz
City
Gyor
State/Province
Győr-Moson-Sopron
ZIP/Postal Code
9024
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Országos Onkológiai Intézet
City
Budapest
State/Province
Pest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Rabin Medical Center
City
Petah Tikva
State/Province
HaMerkaz
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Rosenbaum
Facility Name
Yitzhak Shamir Medical Center
City
Zerifin
State/Province
HaMerkaz
ZIP/Postal Code
6093000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raya Leibowitz
Facility Name
Rambam Health Care Campus
City
Haifa
State/Province
HaTsafon
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avivit Peer
Facility Name
Sourasky Medical Center
City
Tel Aviv
State/Province
Tell Abīb
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Sarid
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto Oncologico Veneto IRCCS
City
Castelfranco Veneto
State/Province
Veneto
ZIP/Postal Code
31033
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto Europeo di Oncologia IRCCS
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Santa Maria Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
APSS- Presidio Ospedaliero S. Chiara
City
Trento
ZIP/Postal Code
38122
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Japanese Red Cross Nagoya Daini Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshinori Nishikimi
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuaki Matsubara
Facility Name
Kimitsu Chuo Hospital
City
Kisarazu
State/Province
Chiba
ZIP/Postal Code
292-8535
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NAKAMURA KAZUYOSHI
Facility Name
Toho University Sakura Medical Center
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroyoshi Suzuki
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryuji Matsumoto
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshinari Yamasaki
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsushi Mizokami
Facility Name
Kagawa University Hospital
City
Kita
State/Province
Kagawa
ZIP/Postal Code
761-0701
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0878912345
First Name & Middle Initial & Last Name & Degree
Mikio Sugimoto
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroji Uemura
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideaki Miyake
Facility Name
Showa University Hospital
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-8555
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takashi Fukagai
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroaki Kikukawa
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81669451181
First Name & Middle Initial & Last Name & Degree
Masashi Nakayama
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82222288138
First Name & Middle Initial & Last Name & Degree
Sang Joon Shin
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82230105977
First Name & Middle Initial & Last Name & Degree
Jae Lyun Lee
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82234103459
First Name & Middle Initial & Last Name & Degree
Se Hoon Park
Facility Name
Health Pharma Professional Research S.A. de C.V:
City
Ciudad de México
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
5514817472
First Name & Middle Initial & Last Name & Degree
Perla Perez Perez
Facility Name
Actualidad Basada en la Investigación del Cáncer
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44680
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel de la Mora Jimenez
Facility Name
Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
526677215355
First Name & Middle Initial & Last Name & Degree
LUIS ALBERTO CONTRERAS
Facility Name
Scientia Investigacion Clinica S.C.
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
6146883416
First Name & Middle Initial & Last Name & Degree
Enrique Zamudio Lozoya
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
9516035559
First Name & Middle Initial & Last Name & Degree
Francisco Javier Castro Alonso
Facility Name
ETZ Elisabeth
City
Tilburg
State/Province
Noord-Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
St. Antonius Ziekenhuis, locatie Utrecht
City
Utrecht
ZIP/Postal Code
3543 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
0883204734
First Name & Middle Initial & Last Name & Degree
Cornelis Bernardus Hunting
Facility Name
Clinical Best Solutions
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-078
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
City
Opole
State/Province
Opolskie
ZIP/Postal Code
45-061
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Szpitale Pomorskie Sp. z o. o.
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Wielkopolskie Centrum Onkologii
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-866
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Salve Medica
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
91-211
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Provita Profamilia
City
Piotrkow Trybunalski
State/Province
Łódzkie
ZIP/Postal Code
97-300
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
C.M.D.T.A. Neomed
City
Brasov
State/Province
Brașov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Amethyst Radiotherapy Center
City
Florești
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Centrul de Oncologie "Sfântul Nectarie"
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
40727774974
First Name & Middle Initial & Last Name & Degree
Michael Schenker
Facility Name
Radiology Therapeutic Center
City
Otopeni
State/Province
Ilfov
ZIP/Postal Code
075100
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Ciubotaru
Facility Name
Oncopremium Team
City
Baia Mare
State/Province
Maramureș
ZIP/Postal Code
430291
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
0040741074059
First Name & Middle Initial & Last Name & Degree
Filip Dumitru
Facility Name
Centrul medical Focus
City
București
ZIP/Postal Code
021397
Country
Romania
Individual Site Status
Active, not recruiting
Facility Name
Gral Medical Diagnostic Center
City
București
ZIP/Postal Code
031422
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
40726273762
First Name & Middle Initial & Last Name & Degree
Cristina Tiut
Facility Name
Instituto Catalan de Oncologia - Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
8907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Maria Piulats Rodriguez
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Angel Arranz Arija
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
349133682
First Name & Middle Initial & Last Name & Degree
Teresa Alonso Gordoa
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
034913908003
First Name & Middle Initial & Last Name & Degree
Enrique Gonzalez Billalabeitia
Facility Name
Fundación Instituto Valenciano de Oncología
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34961114229
First Name & Middle Initial & Last Name & Degree
Maria Jose Juan Fita
Facility Name
Hospital Infanta Cristina
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Gonzalez Cordero
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Begona Perez Valderrama
Facility Name
National Taiwan University Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10055
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886223123456
First Name & Middle Initial & Last Name & Degree
Chao-Yuan Huang
Facility Name
Taipei Veterans General Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
88622875751932
First Name & Middle Initial & Last Name & Degree
Yi-Hsiu Huang
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886422052121
First Name & Middle Initial & Last Name & Degree
Chao-Hsiang Chang
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
0980971870
First Name & Middle Initial & Last Name & Degree
Wen-Pin Su
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
88633281200
First Name & Middle Initial & Last Name & Degree
See-Tong Pang
Facility Name
Medipol Mega Universite Hastanesi
City
Stanbul
State/Province
İstanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
Phone
905325280486
First Name & Middle Initial & Last Name & Degree
Ahmet Bilici
Facility Name
Izmir Medical Park Hospital
City
Izmir, Karsiyaka
State/Province
İzmir
ZIP/Postal Code
009035575
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
Phone
902323995050
First Name & Middle Initial & Last Name & Degree
Cagatay Arslan
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuksel Urun
Facility Name
Dicle Üniversitesi
City
Diyarbakir
ZIP/Postal Code
21200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammet Ali kaplan
Facility Name
Trakya University
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammet Bekir Hacioglu
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmut Gumus
Facility Name
İnönü Üniversitesi Turgut Özal Tıp Merkezi
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan Harputluoglu
Facility Name
Royal Blackburn Hospital
City
Blackburn
State/Province
Blackburn With Darwen
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Colchester General Hospital
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University College London Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/23jmzMPWglYwUwUN2GWvdM
Description
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) (CYCLONE 3)

Learn more about this trial

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)

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