EMBER-3: A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04975308
Collaborator
(none)
800
239
3
59.3
3.3
0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Jun 13, 2023
Anticipated Study Completion Date :
Sep 13, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Imlunestrant

Imlunestrant administered orally.

Drug: Imlunestrant
Administered orally.
Other Names:
  • LY3484356
  • Active Comparator: Investigator's Choice of Endocrine Therapy

    Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM).

    Drug: Exemestane
    Administered orally.

    Drug: Fulvestrant
    Administered IM.

    Experimental: Imlunestrant plus Abemaciclib

    Imlunestrant plus abemaciclib administered orally.

    Drug: Imlunestrant
    Administered orally.
    Other Names:
  • LY3484356
  • Drug: Abemaciclib
    Administered orally.
    Other Names:
  • LY2835219
  • Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)]

      PFS by investigator assessment

    Secondary Outcome Measures

    1. Overall Survival (OS) [Randomization until death from any cause (estimated as up to 5 years)]

      OS

    2. Objective Response Rate (ORR): Percentage of Participants Who Achieve a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) [Randomization until measured progressive disease (estimated as up to 1 year)]

      ORR

    3. Duration of Response (DoR) [Date of CR or PR to date of disease progression or death due to any cause (estimated up to 3 years)]

      DoR

    4. Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve a Best Overall Response of CR, PR or Stable Disease for Greater than or Equal to (≥) 24 Weeks [Randomization until measured progressive disease (estimated as up to 1 year)]

      CBR

    5. PFS by Estrogen Receptor 1 Gene (ESR1) Mutation Status in Plasma [Randomization to the date of first documented progression of disease or death from any cause (estimated as up to 3 years)]

      Investigator-assessed PFS by ESR1 mutation status in plasma

    6. Progression Free Survival (PFS) [Randomization to the date of first documented progression of disease or death from any cause(estimated as up to 3 years)]

      PFS by blinded independent review

    7. Patient Reported Outcomes (PRO): Time to Worsening of "Worst Pain" [Screening through follow-up (estimated as up to 3 years)]

      Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine."

    8. Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant [Cycle 2 to Cycle 4 (cycle = 28 days)]

      PK: steady state plasma concentrations of imlunestrant

    9. PK: Steady State Plasma Concentrations of Imlunestrant and Abemaciclib [Cycle 2 to Cycle 4 (cycle = 28 days)]

      PK: steady state plasma concentrations of imlunestrant and abemaciclib

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer

    • Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor

    -- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed

    • Must be deemed appropriate for treatment with endocrine therapy

    • If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression

    • Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)

    • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)

    • Have adequate renal, hematologic, and hepatic organ function

    • Must be able to swallow capsules/tablets

    Exclusion Criteria:
    • Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor

    • Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.

    • Have symptomatic or untreated brain metastasis.

    • Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study

    • Known allergic reaction against any of the components of the study treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ironwood Cancer & Research Centers Chandler Arizona United States 85224
    2 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    3 Marin Cancer Care Greenbrae California United States 94904
    4 University of California, Davis - Health Systems Sacramento California United States 95817
    5 Sharp Memorial Hospital San Diego California United States 92123
    6 Banner MD Anderson Cancer Center at North Colorado Medical Center Greeley Colorado United States 80631
    7 Rocky Mountain Cancer Center Lone Tree Colorado United States 80124
    8 Banner MD Anderson Cancer Center at McKee Medical Center Loveland Colorado United States 80538
    9 Univ of Florida School of Medicine Gainesville Florida United States 32610
    10 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    11 Florida Cancer Specialists Sarasota Florida United States 34232
    12 Florida Cancer Specialists West Palm Beach Florida United States 33401
    13 Kaiser Permanente Moanalua Medical Center Honolulu Hawaii United States 96819
    14 Rush University Medical Center Chicago Illinois United States 60612
    15 University of Chi Med Center Chicago Illinois United States 60637
    16 IU Health Ball Memorial Hospital, Inc. Muncie Indiana United States 47303
    17 The University of Louisville, James Graham Brown Cancer Center Louisville Kentucky United States 40202
    18 Minnesota Oncology/Hematology PA Coon Rapids Minnesota United States 55433
    19 Jackson Oncology Associates, PLLC Jackson Mississippi United States 39202
    20 Care Access - Clifton Clifton New Jersey United States 07013
    21 The Valley Hospital Ridgewood New Jersey United States 07450
    22 Broome Oncology Binghamton New York United States 13905
    23 Columbia University Medical Center New York New York United States 10032
    24 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    25 University of North Carolina Medical Center Chapel Hill North Carolina United States 27599
    26 Aultman Hospital Canton Ohio United States 44710
    27 Zangmeister Cancer Center Columbus Ohio United States 43219
    28 Willamette Valley Cancer Institute & Research Ctr. Eugene Oregon United States 97401
    29 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    30 Sarah Cannon Research Institute SCRI Nashville Tennessee United States 37203
    31 Texas Oncology - Austin Central Austin Texas United States 78731
    32 Texas Oncology - Carrollton Carrollton Texas United States 75010
    33 Texas Oncology - Methodist Charlton Cancer Center Dallas Texas United States 75203
    34 Texas Oncology - Medical City Dallas Dallas Texas United States 75230
    35 Texas Oncology - Dallas Presbyterian Hospital Dallas Texas United States 75231
    36 Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    37 Texas Oncology - Denison Denison Texas United States 75020
    38 Texas Oncology Denton Denton Texas United States 76201
    39 Texas Oncology Fort Worth Fort Worth Texas United States 76104
    40 Texas Oncology - Willowbrook Houston Texas United States 77070
    41 Texas Oncology - McKinney McKinney Texas United States 75071
    42 Texas Oncology - Paris Paris Texas United States 75460
    43 Texas Oncology-Plano East Plano Texas United States 75075
    44 Texas Oncology - San Antonio Medical Center San Antonio Texas United States 78240
    45 Texas Oncology - The Woodlands The Woodlands Texas United States 77380
    46 US Oncology The Woodlands Texas United States 77380
    47 Utah Cancer Specialists Salt Lake City Utah United States 84106
    48 University of Vermont Medical Center Burlington Vermont United States 05401
    49 Blue Ridge Cancer Care Salem Virginia United States 24153
    50 Fundación CENIT para la Investigación en Neurociencias Caba BA Argentina C1125ABD
    51 Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires Argentina 7600
    52 CIPREC Ciudad Autonoma de Buenos Aire Ciudad Autónoma De Buenos Aire Argentina C1119ACN
    53 Clinica Viedma S. A Viedma Río Negro Argentina R8500ACE
    54 Instituto Argentino de Diagnóstico y Tratamiento (IADT) Buenos Aires Argentina 1122
    55 Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC Cordoba Argentina X5008HHW
    56 Instituto San Marcos San Juan Argentina 5400
    57 Sanatorio Norte Santiago del Estero Argentina 4200
    58 St Vincent's Hospital Darlinghurst New South Wales Australia 2010
    59 Princess Alexandra Hospital Brisbane Queensland Australia 4102
    60 Cancer Research SA Adelaide South Australia Australia 5000
    61 Box Hill Hospital Box Hill Victoria Australia 3128
    62 Maroondah Hospital Melbourne Victoria Australia 3135
    63 Universitätsklinikum Graz Graz Steiermark Austria 8036
    64 Private Practice - Dr. Hubalek Schwaz Tirol Austria 6130
    65 Medizinische Universität Wien Vienna Wien Austria 1090
    66 Universitätsklinikum Salzburg Salzburg Austria 5020
    67 Imelda General Hospital Bonheiden Antwerpen Belgium 2820
    68 UZ Brussel Brussels Bruxelles-Capitale, Région De Belgium 1090
    69 UZ Gent Gent Oost-Vlaanderen Belgium 9000
    70 VITAZ Sint-Niklaas Oost-Vlaanderen Belgium B-9100
    71 AZ Groeninge Campus Kennedylaan Kortrijk West-Vlaanderen Belgium 8500
    72 Institut Jules Bordet Brussels-Capital Belgium 1070
    73 Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium 3000
    74 Hospital de Cancer de Londrina Londrina Paraná Brazil 86015-520
    75 Faculdade de Medicina do ABC Santo Andre SP Brazil 09060-650
    76 Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo Brazil 01246-000
    77 Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA São Paulo Brazil 01317-001
    78 IBCC - Instituto Brasileiro de Controle do Câncer São Paulo Brazil 04014-002
    79 Afflilated Hospital of Bengbu Medical College Bengbu Anhui China 233004
    80 Beijing Hospital Beijing Beijing China 100005
    81 The Fifth Medical Center of PLA General Hospital Beijing Beijing China 100071
    82 Beijing Cancer hospital Beijing Beijing China 100142
    83 Sun Yat-Sen University Cancer Centre Guangzhou Guangdong China 511400
    84 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
    85 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan China 471003
    86 People's Hospital of Henan Province Zhengzhou Henan China 450003
    87 Renmin Hospital of Wuhan University Wuhan Hubei China 430060
    88 Hubei Cancer Hospital Wuhan Hubei China 430079
    89 The First People's Hospital of Changde City Changde Hunan China 415003
    90 Hunan Provincial People's Hospital ChangSha Hunan China 410005
    91 Xiangya Hospital Central South University Changsha Hunan China 410008
    92 Hunan Cancer Hospital Changsha Hunan China 421000
    93 The Third Hospital of Nanchang Nanchang Jiangxi China 330009
    94 The Second Hospital of Jilin University Changchun Jilin China 130000
    95 The First Hospital of Jilin University Changchun Jilin China 130021
    96 Jiangsu Province Hospital Nanjing Nanjing China 210029
    97 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710061
    98 Jinan Central Hospital Jinan Shandong China 250013
    99 Yantai Yuhuangding Hospital Yantai Shandong China 264000
    100 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China
    101 Xinjiang Medical University Cancer Hospital - Urumqi Urumqi Xinjiang China 830000
    102 The First Affiliated Hospital, Zhejiang University Hangzhou Zhejiang China 310003
    103 Sir Run Run Shaw Hospital Hangzhou Zhejiang China 310016
    104 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    105 Hwa Mei Hospital University of Chinese Academy of Sciences Ningbo Zhejiang China 315010
    106 Sichuan Cancer Hospital Chengdu China 610041
    107 Jining Medical University - Affiliated Hospital Jining China 272029
    108 Wu Han Tongji Hospital Wuhan China 430030
    109 Thomayerova nemocnice Praha Praha 4 - Krč Czechia 14059
    110 Nemocnice Na Bulovce Prague Praha 8 Czechia 180 81
    111 Nemocnice Horovice Horovice Czechia 268 01
    112 Fakultni nemocnice Kralovske Vinohrady Praha 10 Czechia 100 34
    113 Oblastní nemocnice Příbram, a.s. Pribram Czechia 261 01
    114 Institut de cancérologie Strasbourg Europe (ICANS) Strasbourg Alsace France 67033
    115 CHU Besançon Besançon Doubs France 25000
    116 Centre de Cancérologie du Grand Montpellier Montpellier Languedoc-Roussillon France 34070
    117 Institut de Cancérologie de Lorraine Alexis Vautrin Vandoeuvre-lès-Nancy Lorraine France 54519
    118 Centre Hospitalier de la Côte Basque Bayonne Pyrénées-Atlantiques France 64109
    119 Polyclinique De Blois La Chaussee Saint Victor France 41260
    120 Clinique Victor Hugo - Centre Jean Bernard Le Mans France 72000
    121 Institut Curie Paris France 75248
    122 Institut Curie Saint-Cloud Île-de-France France 92210
    123 Klinikum Ludwigsburg Ludwigsburg Baden-Württemberg Germany 71640
    124 Universitätsklinikum Erlangen Erlangen Bayern Germany 91054
    125 Klinikum der Ludwig-Maximilians-Universitaet Muenchen München Bayern Germany 80337
    126 Agaplesion Markus Krankenhaus Frankfurt Hessen Germany 60431
    127 Gynäkologisch-Onkologische Praxis am Pelikanplatz Hannover Niedersachsen Germany 30177
    128 Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung Essen Nordrhein-Westfalen Germany 45136
    129 Evangelisches Krankenhaus Bethesda Mönchengladbach Mönchengladbach Nordrhein-Westfalen Germany 41061
    130 Universitaetsklinikum Schleswig-Holstein Campus Kiel Kiel Schleswig-Holstein Germany 24105
    131 Agios Savvas Regional Cancer Hospital Athens Attikí Greece 115 22
    132 Alexandra General Hospital of Athens Athens Attikí Greece 11528
    133 General Oncology Hospital of Kifissia "Agioi Anargiroi" Nea Kifissia Attikí Greece 14564
    134 University General Hospital of Heraklion Heraklion Irakleío Greece 711 10
    135 Euromedica General Clinic of Thessaloniki Thessaloniki Thessaloníki Greece 546 45
    136 European Interbalkan Medical Center Thessaloniki Thessaloníki Greece 570 01
    137 General Hospital of Thessaloniki Papageorgiou Thessaloniki Greece 56403
    138 Maulana Azad Medical College New Delhi Delhi India 110002
    139 HCG-Bangalore Bengaluru Karnataka India 560027
    140 Regional Cancer Centre - Thiruvananthapuram Thiruvananthapuram Kerala India 695011
    141 HCG Cancer Centre Mumbai Maharashtra India 400092
    142 Government Medical College And Hospital - Nagpur Nagpur Maharashtra India 440003
    143 HCG Manavata Cancer Centre Nashik Maharashtra India 422001
    144 Deenanath Mangeshkar Hospital & Research Centre Pune Maharashtra India 411004
    145 Yashoda Hospitals Hyderabad Telangana India 500082
    146 University of Naples Federico II Naples Campania Italy 80100
    147 Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli Campania Italy 80131
    148 Cro-Irccs Aviano Friuli-Venezia Giulia Italy 33081
    149 Fondazione Policlinico Universitario Agostino Gemelli Roma Lazio Italy 00168
    150 Fondazione IRCCS Istituto Nazionale dei Tumori Milan Lombardia Italy 20133
    151 Azienda Ospedaliera Universitaria Careggi Firenze Toscana Italy 50134
    152 Ospedale San Martino Genova Italy 16132
    153 Istituto Europeo di Oncologia IRCCS Milano Italy 20141
    154 Azienda Ospedaliero Universitaria Modena Italy 41125
    155 Istituto Oncologico Veneto IRCCS Padova Italy 35128
    156 Nagoya University Hospital Nagoya Aichi Japan 466-8560
    157 Chiba cancer center Chiba-shi Chiba Japan 260-8717
    158 National Hospital Organization Shikoku Cancer Center Matsuyama Ehime Japan 791-0280
    159 Kurume General Hospital Kurume Fukuoka Japan 830-0013
    160 Gunma Prefectural Cancer Center Ota Gunma Japan 373-0828
    161 National Hospital Organization Hokkaido Cancer Center Sapporo Hokkaido Japan 003-0804
    162 Hyogo Cancer Center Akashi Hyogo Japan 673-8558
    163 University of tsukuba hospital Tsukuba-shi Ibaragi Japan 305-8576
    164 St. Marianna University Hospital Kawasaki Kanagawa Japan 216-8511
    165 Kanagawa cancer center Yokohama Kanagawa Japan 241-8515
    166 Niigata Cancer Center Hospital Niigata-shi Niigata Japan 951-8566
    167 Juntendo University Hospital Bunkyo-ku Tokyo Japan 113-8431
    168 National Cancer Center Hospital Chuo-ku Tokyo Japan 104-0045
    169 Showa University Hospital Shinagawa Tokyo Japan 142-8555
    170 National Hospital Organization Kyushu Cancer Center Fukuoka Japan 811-1395
    171 Hiroshima City Hospital Hiroshima Japan 730-8518
    172 Sagara Hospital Kagoshima Japan 892-0833
    173 Kumamoto Shinto General Hospital Kumamoto Japan 862-8655
    174 Osaka International Cancer Institute Osaka Japan 541-8567
    175 Shizuoka Prefectural General Hospital Shizuoka Japan 420-0881
    176 Soon Chun Hyang University Cheonan Hospital Cheonan-si Chungcheongnam-do [Chungnam] Korea, Republic of 31151
    177 Gachon University Gil Medical Center Namdong-gu Incheon-gwangyeoksi [Incheon] Korea, Republic of 21565
    178 Severance Hospital, Yonsei University Health System Seoul Korea Korea, Republic of 03722
    179 Ajou University Hospital Suwon-si Kyǒnggi-do Korea, Republic of 16499
    180 Yeungnam Univeristy Medical Center Gyeongsan-si Kyǒngsangbuk-do Korea, Republic of 42415
    181 Dong-A University Hospital Busan Pusan-Kwangyǒkshi Korea, Republic of 49201
    182 Seoul National University Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 03080
    183 Kangbuk Samsung Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 03181
    184 Asan Medical Center Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 05505
    185 Gangnam Severance Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 06273
    186 Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 06351
    187 Centro de Investigación Clínica de Alta Especialidad Torreón Coahuila Mexico 27010
    188 Grupo Medico Camino Sc Mexico City Distrito Federal Mexico 03310
    189 Christus Muguerza Clinica Vidriera (Christus Muguerza Sistemas Hospitalarios S.A. de C.V.) Monterrey Nuevo León, C.P. Monterrey Mexico 64570
    190 COI Centro Oncológico Intl. S.A.P.I. de C.V._ S.F. Paso De Las Lomas MX Mexico 01330
    191 Private Practice - Dr. Joaquin Reinoso Monterrey Nuevo León Mexico 64320
    192 Centro Medico Zambrano Hellion San Pedro Garza Garcia Nuevo León Mexico 66278
    193 Unidad de Investigación en Salud Chihuahua Mexico 31203
    194 Oaxaca Site Management Organization Oaxaca Mexico 68000
    195 Unidad Médica Onco-hematológica Puebla Mexico 72424
    196 Medische Centrum Leeuwarden Leeuwarden Fryslân Netherlands 8934 AD
    197 Maastricht UMC+ Maastricht Limburg Netherlands 6229 HX
    198 Haga Ziekenhuis locatie Leyweg Den Haag Zuid-Holland Netherlands 2545 AA
    199 N.N.Petrov Research Institute of Oncology St. Petersburg Peterburg Russian Federation 197758
    200 Volgograd Regional Clinical Cancer Clinic No.1 Volgograd Volgogradskaya Oblast' Russian Federation 400138
    201 SHI Kaluga Regional Hospital Kaluga Russian Federation 248007
    202 Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona] Spain 08035
    203 Hospital de la Santa Creu i Sant Pau Barcelona Catalunya [Cataluña] Spain 08041
    204 Hospital Universitari Arnau de Vilanova Lleida Cataluña Spain 25198
    205 Hospital Universitario Ramón y Cajal Madrid Madrid, Comunidad De Spain 28034
    206 Hospital Universitario de Canarias La Laguna Santa Cruz De Tenerife Spain 38320
    207 Hospital Universitario San Cecilio Granada Spain 18016
    208 Hospital Clinico San Carlos Madrid Spain 28040
    209 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    210 Hospital Universitario Virgen Del Rocio Sevilla Spain 41013
    211 Hospital Clínico Universitario de Valencia Valencia Spain 46010
    212 Hospital Quirón Salud Valencia Valencia Spain 46010
    213 Chi Mei Hospital - Liouying Branch Tainan City Tainan Taiwan 73657
    214 Taichung Veterans General Hospital Taichung Taiwan 40705, ROC
    215 National Cheng-Kung Uni. Hosp. Tainan Taiwan 704
    216 National Taiwan University Hospital Taipei Taiwan 10002
    217 Koo Foundation Sun Yat-Sen Cancer Center Taipei Taiwan 112
    218 Acibadem Altunizade Hospital Üsküdar / Stanbul İstanbul Turkey
    219 Ege University Medicine of Faculty Bornova İzmir Turkey 35100
    220 Baskent University Dr. Turgut Noyan Research and Training Center Adana Turkey 01250
    221 University of Health Sciences,Gulhane School of Medicine Ankara Turkey 06010
    222 Hacettepe Universitesi Ankara Turkey 06230
    223 Memorial Ankara Hastanesi Ankara Turkey 06520
    224 Ankara City Hospital Ankara Turkey 06800
    225 Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital Ankara Turkey
    226 Akdeniz University Medical Faculty Antalya Turkey 07059
    227 Dicle Üniversitesi Diyarbakir Turkey 21200
    228 Trakya University Edirne Turkey 22030
    229 Medipol Mega University Hospital Istanbul Turkey 34214
    230 Acıbadem Maslak Hastanesi İstanbul Turkey 34457
    231 TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Istanbul Turkey 34722
    232 İnönü Üniversitesi Turgut Özal Tıp Merkezi Malatya Turkey 44280
    233 Mersin University Mersin Turkey 33343
    234 MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department Kryvyi Rih Dnipropetrovska Oblast Ukraine 50048
    235 CNPE "Regional Center of Oncology" Kharkiv Kharkivska Oblast Ukraine 61070
    236 Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council Odesa Odeska Oblast Ukraine 65025
    237 Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" Vinnytsia Vinnytska Oblast Ukraine 21029
    238 Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council Lutsk Volynska Oblast Ukraine 43018
    239 Uzhgorod Central City Clinical Hospital Uzhhorod Zakarpatska Oblast Ukraine 88000

    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:
    NCT04975308
    Other Study ID Numbers:
    • 18175
    • J2J-OX-JZLC
    • 2021-000079-35
    First Posted:
    Jul 23, 2021
    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:

    Study Results

    No Results Posted as of Aug 19, 2022