A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
NCT ID: NCT06629779
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
900 participants
INTERVENTIONAL
2024-10-22
2028-11-30
Brief Summary
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Detailed Description
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This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Participants and their caregivers will be blinded to their assigned study intervention.
Investigators and other site staff will be blinded to participants' assigned study intervention Sponsor staff will be blinded to participants' assigned study intervention, except for sponsor staff involved in the assignment or distribution of study intervention.
Study Groups
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Arm A
Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
PF-06821497
Oral continuous
Enzalutamide
Oral continuous
Arm B
Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
Placebo
Oral continuous
Enzalutamide
Oral continuous
Interventions
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PF-06821497
Oral continuous
Placebo
Oral continuous
Enzalutamide
Oral continuous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Progressive disease in the setting of medical or surgical castration.
* ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
Exclusion Criteria
* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
* Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
* Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:
1. Treatment with first-generation antiandrogen (ADT) agents;
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
* Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
* Inadequate organ function.
18 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Palo Verde Hematology Oncology
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Highlands Oncology
Fayetteville, Arkansas, United States
Arkansas Urology - Little Rock
Little Rock, Arkansas, United States
Highlands Oncology
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Los Angeles Cancer Network (LACN)
Anaheim, California, United States
Los Angeles Cancer Network (LACN)
Fountain Valley, California, United States
Los Angeles Cancer Network (LACN)
Glendale, California, United States
Los Angeles Cancer Network (LACN)
Glendale, California, United States
Adventist Health Physicians Network
Hidden Valley Lake, California, United States
Los Angeles Cancer Network (LACN)
Los Angeles, California, United States
Los Angeles Cancer Network (LACN)
Los Angeles, California, United States
Adventist Health Physicians Network
Napa, California, United States
Medical Oncology Associates of San Diego
San Diego, California, United States
Adventist Health St. Helena
St. Helena, California, United States
Accellacare of Duly
Lisle, Illinois, United States
Duly Health and Care (Bone Scintigraphy)
Lisle, Illinois, United States
Blessing Hospital
Quincy, Illinois, United States
Blessing Physician Services
Quincy, Illinois, United States
Duly Health and Care (CT and MRI)
Westmont, Illinois, United States
Adult & Pediatric Urology, PC
Omaha, Nebraska, United States
CHRISTUS St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Montefiore Medical Center - Medical Park
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Salisbury VA Medical Center
Salisbury, North Carolina, United States
AUC Urologists, LLC
Myrtle Beach, South Carolina, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States
Parkway Surgery Center
Myrtle Beach, South Carolina, United States
USA Clinical Trials
San Antonio, Texas, United States
Northwest Medical Specialties, PLLC
Bonney Lake, Washington, United States
Northwest Medical Specialties, PLLC
Federal Way, Washington, United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Centro de Urología (CDU)
CABA, Buenos Aires, Argentina
Hospital Sirio Libanes
Capital Federal, Buenos Aires, Argentina
Imagenes Mdq
Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina
Centro Medico Privado CEMAIC
Capital, Córdoba Province, Argentina
Hospital Privado Universitario de Córdoba
Córdoba, Córdoba Province, Argentina
IMAXE
Buenos Aires, , Argentina
Asociación de Beneficencia Hospital Sirio Libanés
Buenos Aires, , Argentina
Centro Medico Fleischer
Buenos Aires, , Argentina
Oncocentro Servico Medicos e Hospitalares Ltda
Fortaleza, Ceará, Brazil
Hospital São Carlos
Fortaleza, Ceará, Brazil
Oncocentro Oncologia
Fortaleza, Ceará, Brazil
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, Estado de Bahia, Brazil
Hospital Da Bahia
Salvador, Estado de Bahia, Brazil
Clinica Amo - Rio Vermelho
Salvador, Estado de Bahia, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
MedPlex Eixo Norte
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, , Brazil
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
Gabrovo, , Bulgaria
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, , Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, , Bulgaria
Complex Oncology Center Stara Zagora EOOD
Stara Zagora, , Bulgaria
Prostate Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
QEII Health Sciences Centre - Victoria General Site
Halifax, Nova Scotia, Canada
Lakeridge Health
Oshawa, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
IC La Serena Research
La Serena, Coquimbo Region, Chile
Clinica Universidad Catolica del Maule
Talca, Maule Region, Chile
Centro de Investigacion Clinica del Sur
Temuco, Región de la Araucanía, Chile
Oncocentro Apys
Viña del Mar, Región de Valparaíso, Chile
Fundación Arturo López Pérez
Providencia, Santiago Metropolitan, Chile
Fundacion Arturo Lopez Perez
Providencia, Santiago Metropolitan, Chile
Oncovida
Providencia, Santiago Metropolitan, Chile
Centro de Estudios Clínicos SAGA
Santiago, Santiago Metropolitan, Chile
FALP
Santiago, Santiago Metropolitan, Chile
Bradfordhill
Santiago, Santiago Metropolitan, Chile
Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Shantou University School of Medicine
Shantou, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shaanxi Provincial People' Hospital
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang/nanhu, China
Peking University Third Hospital
Beijing, , China
First Affiliated Hospital of China Medical University
Shenyang, , China
Fakultni nemocnice Ostrava
Ostrava, Moravskoslezský kraj, Czechia
Fakultní nemocnice Ostrava
Ostrava - Poruba, Moravskoslezský kraj, Czechia
Fakultni nemocnice Olomouc
Olomouc, Olomoucký kraj, Czechia
Multiscan
Pardubice, Pardubický kraj, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha 10, Czechia
Urocentrum Praha
Prague, Praha 2, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia
Krajská nemocnice Liberec
Liberec, , Czechia
Næstved Sygehus
Næstved, Region Sjælland, Denmark
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
Vejle Sygehus
Vejle, Region Syddanmark, Denmark
Oulun yliopistollinen sairaala
Oulu, North Ostrobothnia, Finland
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, Finland
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Helsinki university hospital
Helsinki, , Finland
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, Alsace, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, Aquitaine, France
Centre Leon Berard
Lyon Cedex08, Auvergne-Rhône-Alpes, France
CHRU de Brest
Brest, Finistère, France
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, Ille-et-vilaine, France
Institut de Cancérologie de l'Ouest
Saint-Herblain, Loire-atlantique, France
Institut Jean Godinot
Reims, Marne, France
Clinique Victor Hugo Le Mans
Le Mans, Pays de la Loire Region, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
Clermont-Ferrand, , France
Institut Godinot
Reims, , France
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
University Hospital of Patras
Pátrai, Achaḯa, Greece
Alexandra General Hospital of Athens
Athens, Attikí, Greece
Athens Medical Center
Athens, Attikí, Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece
University General Hospital of Larissa
Larissa, Thessalía, Greece
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház
Miskolc, Borsod-Abauj Zemplen county, Hungary
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary
Nograd Varmegyei Szent Lazar Korhaz
Salgótarján, Nógrád megye, Hungary
Országos Onkológiai Intézet
Budapest, Pest County, Hungary
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena
Rome, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, , Italy
Ospedale San Raffaele
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, , Italy
Azienda Ospedaliera Santa Maria Terni
Terni, , Italy
APSS- Presidio Ospedaliero S. Chiara
Trento, , Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
Verona, , Italy
Chiba cancer center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Keio university hospital
Shinjuku-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Yamagata University Hospital
Yamagata, , Japan
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, Netherlands
Frisius Medisch Centrum
Leeuwarden, Provincie Friesland, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland
Schiedam, South Holland, Netherlands
Imed Radiology
Tauranga, Bay of Plenty, New Zealand
Tauranga Hospital
Tauranga, Bay of Plenty, New Zealand
Christchurch Hospital
Christchurch, Canterbury, New Zealand
Waikato Hospital
Hamilton, Waikato Region, New Zealand
Auckland City Hospital
Auckland, , New Zealand
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
MICS Centrum Medyczne Torun
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
Wroclaw, Lower Silesian Voivodeship, Poland
Clinical Best Solutions
Lublin, Lublin Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie
Koszalin, West Pomeranian Voivodeship, Poland
Provita Profamilia
Piotrkow Trybunalski, Łódź Voivodeship, Poland
CUIMED, s.r.o., Urologicka ambulancia
Bratislava, , Slovakia
Univerzitna nemocnica Martin
Martin, , Slovakia
Privatna urologicka ambulancia, s.r.o.
Trenčín, , Slovakia
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, South Africa
Wilgers Oncology Centre
Pretoria, Gauteng, South Africa
Wits Clinical Research
Soweto, Gauteng, South Africa
TASK Eden
George, Western Cape, South Africa
Chonnam National University Hwasun Hospital
Hwasun, Jeonranamdo, South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyungpook National University Chilgok Hospital
Daegu, Taegu-kwangyǒkshi, South Korea
Chungnam national university hospital
Junggu, Taejǒn-kwangyǒkshi, South Korea
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña], Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Södersjukhuset
Stockholm, Stockholms LÄN [se-01], Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Koç Üniversitesi Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
I.E.U. Medical Point Hastanesi
Izmir, İ̇zmir, Turkey (Türkiye)
Sbü Gülhane Eğitim Ve Araştirma Hastanesi
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Ankara University Health Practice and Research Hospitals
Ankara, , Turkey (Türkiye)
Royal Blackburn Hospital
Blackburn, Blackburn WITH Darwen, United Kingdom
Mid and South Essex NHS Foundation Trust
Chelmsford, Essex, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, , United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2024-511652-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C2321003
Identifier Type: -
Identifier Source: org_study_id