Estudo de Patritumab Deruxtecan em participantes com câncer gastrointestinal (MK-1022-011)
Um estudo de fase 1/2 para avaliar a segurança e eficácia do Patritumab Deruxtecan em cânceres gastrointestinais
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn:
- About the safety and how well people tolerate of patritumab deruxtecan
- How many people have the cancer respond (get smaller or go away) to treatment
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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New South Wales
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Sydney, New South Wales, Austrália, 2145
- Westmead Hospital ( Site 0100)
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Victoria
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Melbourne, Victoria, Austrália, 3004
- Alfred Health ( Site 0102)
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Melbourne, Victoria, Austrália, 3084
- Austin Health ( Site 0103)
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Western Australia
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Mount Pleasant, Western Australia, Austrália, 6009
- One Clinical Research ( Site 0104)
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 2Y9
- QEII Health Sciences Centre - Victoria General Site ( Site 0200)
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Ontario
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)
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Quebec
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Montreal, Quebec, Canadá, H4A 3J1
- McGill University Health Centre ( Site 0202)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 8420383
- Bradfordhill ( Site 0300)
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Santiago, Region M. de Santiago, Chile, 7500921
- Fundacion Arturo Lopez Perez ( Site 0301)
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Santiago, Region M. de Santiago, Chile, 7560908
- Centro de Oncología de Precisión ( Site 0305)
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Santiago, Region M. de Santiago, Chile, 7620002
- Clínica UC San Carlos de Apoquindo ( Site 0302)
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Anhui
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Hefei, Anhui, China, 230088
- The First Affiliated Hospital of Anhui Medical University ( Site 0405)
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Fujian
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Fuzhou, Fujian, China, 350014
- Fujian Provincial Cancer Hospital ( Site 0408)
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Xiamen, Fujian, China, 361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)
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Guangdong
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Fuzhou, Guangdong, China, 510515
- Southern Medical University Nanfang Hospital ( Site 0413)
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Guangzhou, Guangdong, China, 510080
- The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)
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Guangxi
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Nanning, Guangxi, China, 530200
- Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)
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Henan
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Zhengzhou, Henan, China, 450008
- Henan Cancer Hospital ( Site 0403)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Zhongshan Hospital,Fudan University ( Site 0400)
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Shanxi
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Taiyuan, Shanxi, China, 030001
- First Hospital of Shanxi Medical University ( Site 0409)
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Seoul, Coréia do Sul, 03722
- Severance Hospital, Yonsei University Health System ( Site 0903)
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Seoul, Coréia do Sul, 05505
- Asan Medical Center ( Site 0902)
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Seoul, Coréia do Sul, 06351
- Samsung Medical Center ( Site 0901)
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Seoul
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Seodaemun-gu, Seoul, Coréia do Sul, 03080
- Seoul National University Hospital ( Site 0900)
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Barcelona, Espanha, 08035
- Hospital Universitari Vall d Hebron ( Site 1000)
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Madrid, Espanha, 28007
- Hospital Universitario Gregorio Maranon ( Site 1002)
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Madrid, Espanha, 28040
- Hospital Clinico San Carlos... ( Site 1003)
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Principality of Asturias
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Oviedo, Principality of Asturias, Espanha, 33011
- Hospital Central de Asturias ( Site 1001)
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California
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Santa Monica, California, Estados Unidos, 90404
- UCLA Hematology Oncology Santa Monica ( Site 1205)
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Cancer Center ( Site 1200)
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20016
- Sibley Memorial Hospital ( Site 1208)
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida ( Site 1202)
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Miami Beach, Florida, Estados Unidos, 33140
- Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
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Georgia
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Marietta, Georgia, Estados Unidos, 30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- University of Chicago Medical Center ( Site 1204)
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Nevada
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Reno, Nevada, Estados Unidos, 89502
- Renown Regional Medical Center ( Site 1221)
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New York
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Mineola, New York, Estados Unidos, 11501
- NYU Langone Hospital - Long Island ( Site 1230)
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New York, New York, Estados Unidos, 10016
- Perlmutter NYU Cancer Center ( Site 1212)
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Texas
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Temple, Texas, Estados Unidos, 76508
- Scott & White Medical Center-Temple ( Site 1224)
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Virginia
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Roanoke, Virginia, Estados Unidos, 24014
- Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin ( Site 1210)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, França, 69004
- Hopital de la Croix Rousse ( Site 0502)
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Hauts-de-Seine
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Clichy, Hauts-de-Seine, França, 92110
- Hopital Beaujon ( Site 0500)
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, França, 35042
- Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)
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Haifa, Israel, 3109601
- Rambam Health Care Campus ( Site 0603)
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Jerusalem, Israel, 9112001
- Hadassah Medical Center ( Site 0602)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 0601)
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Milan, Itália, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)
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Milan, Itália, 20162
- ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)
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Roma, Itália, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)
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Auckland, Nova Zelândia, 1023
- Harbour Cancer & Wellness ( Site 0800)
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Geneva, Suíça, 1211
- Hopitaux Universitaires de Geneve HUG. ( Site 1102)
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Zurich, Suíça, 8091
- Universitaetsspital Zuerich ( Site 1105)
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Bangkok
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Bangkoknoi, Bangkok, Tailândia, 10700
- Faculty of Medicine Siriraj Hospital ( Site 1301)
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Ratchathewi, Bangkok, Tailândia, 10400
- Ramathibodi Hospital ( Site 1302)
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)
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Taipei, Taiwan, 10002
- National Taiwan University Hospital ( Site 1500)
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Taipei, Taiwan, 112201
- Taipei Veterans General Hospital ( Site 1501)
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Adana, Turquia (Türkiye), 01370
- Adana City Hospital ( Site 1404)
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Ankara, Turquia (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 1401)
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Ankara
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Yenimahalle, Ankara, Turquia (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)
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İzmir
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Balçova, İzmir, Turquia (Türkiye), 35340
- Dokuz Eylul Universitesi Hastanesi ( Site 1402)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
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Has one of the following cancers:
- Unresectable or metastatic colorectal cancer.
- Advanced and/or unresectable biliary tract cancer (BTC)
- Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
- Locally advanced unresectable or metastatic gastroesophageal cancer
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Has received prior therapy for the cancer.
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Has recovered from any side effects due to previous cancer treatment
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
- Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
- Has evidence of any leptomeningeal disease
- Has clinically significant corneal disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Patritumab deruxtecan
Participants receive patritumab deruxtecan intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision. |
Administered via intravenous (IV) infusion
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
Prazo: Up to 21 days
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DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented. |
Up to 21 days
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|
Number of Participants with One or More Adverse Events (AEs)
Prazo: Up to approximately 44 months
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An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented. |
Up to approximately 44 months
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|
Number of Participants who Discontinue Study Intervention Due to an AE
Prazo: Up to approximately 44 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented. |
Up to approximately 44 months
|
|
Objective Response Rate (ORR)
Prazo: Up to approximately 44 months
|
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. |
Up to approximately 44 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duration of Response (DOR)
Prazo: Up to approximately 44 months
|
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. |
Up to approximately 44 months
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|
Progression Free Survival (PFS)
Prazo: Up to approximately 44 months
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PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. |
Up to approximately 44 months
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|
Overall Survival (OS)
Prazo: Up to approximately 44 months
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OS is the length of time from when the participant starts treatment until death from any cause. |
Up to approximately 44 months
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Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan
Prazo: At designated time points (up to ~44 months)
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Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan. |
At designated time points (up to ~44 months)
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Trough Concentration (Ctrough) of Patritumab Deruxtecan
Prazo: At designated time points (up to ~44 months)
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Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan. |
At designated time points (up to ~44 months)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Medical Director, Merck Sharp & Dohme LLC
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1022-011
- MK-1022-011 (Outro identificador: MSD)
- U1111-1305-0677 (Identificador de registro: UTN)
- 2024-512442-41-00 (Identificador de registro: EU CT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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