Um estudo de substituição para participantes previamente inscritos em um estudo patrocinado pela Genentech e/ou F. Hoffman-La Roche (UmbrellaMAX)
Um estudo de extensão multicêntrico aberto em pacientes previamente inscritos em um estudo patrocinado pela Genentech e/ou F. Hoffmann-La Roche Ltd
The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Estude backup de contato
- Nome: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- Número de telefone: 888-662-6728 (U.S. Only)
- E-mail: global-roche-genentech-trials@gene.com
Locais de estudo
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Charleroi, Bélgica, 6060
- Concluído
- GHdC Site Les Viviers
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Kortrijk, Bélgica, 8500
- Ativo, não recrutando
- AZ Groeninge
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Leuven, Bélgica, 3000
- Ativo, não recrutando
- UZ Leuven Gasthuisberg
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Leuven, Bélgica, 3000
- Concluído
- UZ Leuven Gasthuisberg
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Ontario
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Toronto, Ontario, Canadá, M5G 1Z5
- Recrutamento
- Princess Margaret Cancer Center
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Beijing, China, 100142
- Recrutamento
- Beijing Cancer Hospital
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Changchun, China, 130021
- Recrutamento
- the First Hospital of Jilin University
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Chengdu, China, 610041
- Recrutamento
- West China Hospital of Sichuan University
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Guangzhou, China, 510515
- Recrutamento
- Nanfang Hospital, Southern Medical University
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Guangzhou, China, 510000
- Recrutamento
- Cancer Center of Guangzhou Medical University
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Hangzhou, China, 310022
- Recrutamento
- Zhejiang Cancer Hospital
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Hangzhou, China, 310014
- Recrutamento
- Zhejiang People's Hospital
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Hangzhou, China, 310016
- Recrutamento
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, China, 150081
- Recrutamento
- Harbin Medical University Cancer Hospital
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Hefei, China, 230601
- Recrutamento
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, China, 514031
- Recrutamento
- Meizhou People's Hospital
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Nanchang, China, 330052
- Recrutamento
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, China, 210029
- Recrutamento
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, China, 200030
- Recrutamento
- Shanghai Chest Hospital
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Shanghai, China, 200120
- Recrutamento
- Fudan University Shanghai Cancer Center
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Shanghai, China, 201104
- Recrutamento
- Shanghai Geriatric Medical Center
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Tianjin, China, 300060
- Recrutamento
- Tianjin Cancer Hospital
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Xi'an, China, 710061
- Recrutamento
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, China, 710126
- Recrutamento
- Xi'an International Medical Center Hospital
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Xiamen, China, 361003
- Recrutamento
- The First Affiliated Hospital of Xiamen University
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Xinxiang, China
- Recrutamento
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, China, 450008
- Recrutamento
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, China, 430048
- Recrutamento
- Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
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Shaanxi
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XI 'an City, Shaanxi Province, Shaanxi, China, 710061
- Recrutamento
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Recrutamento
- Fudan University Shanghai Cancer Center
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Goyang-si, Coréia do Sul, 10408
- Recrutamento
- National Cancer Center
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Gyeonggi-do, Coréia do Sul, 13496
- Recrutamento
- CHA Bundang Medical Center
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Seongnam-si, Coréia do Sul, 463-707
- Concluído
- Seoul National University Bundang Hospital
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Seoul, Coréia do Sul, 06351
- Recrutamento
- Samsung Medical Center
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Seoul, Coréia do Sul, 05505
- Ativo, não recrutando
- Asan Medical Center
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San José, Costa Rica, 10103
- Ativo, não recrutando
- Clinica CIMCA
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San José, Costa Rica, 10108
- Ativo, não recrutando
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bordeaux, França, 33076
- Recrutamento
- Institut Bergonie
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Caen, França, 14076
- Recrutamento
- Centre Francois Baclesse
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Dijon, França, 21000
- Recrutamento
- Institut de Cancérologie de Bourgogne
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Lyon, França, 69373
- Recrutamento
- Centre Leon Berard
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Marseille, França, 13005
- Recrutamento
- Hopital de la Timone
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Montpellier, França, 34298
- Recrutamento
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, França, 44093
- Recrutamento
- CHU de Nantes - Hotel Dieu
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Nîmes, França, 30029
- Concluído
- Institut de cancerologie du Gard
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Paris, França, 75005
- Recrutamento
- Institut Curie
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Paris, França, 75970
- Recrutamento
- Hopital Tenon
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Saint-Herblain, França, 44805
- Recrutamento
- ICO - Site René Gauducheau
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Toulouse, França, 31059
- Recrutamento
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, França, 54511
- Recrutamento
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, França, 94800
- Recrutamento
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, França, 13005
- Recrutamento
- AP-HM- Hôpital de La Timone
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Asvestochóri, Grécia, 570 10
- Recrutamento
- General Hospital "G.Papanikolaou"
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Cholargós, Grécia, 155 62
- Recrutamento
- Metropolitan General Hospital
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Chiba, Japão, 277-8577
- Recrutamento
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, Japão, 810-8563
- Recrutamento
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japão, 812-8582
- Recrutamento
- Kyushu University Hospital
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Kanagawa, Japão, 232-0024
- Ativo, não recrutando
- Yokohama City University Medical Center
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Kanagawa, Japão, 241-8515
- Concluído
- Kanagawa Cancer Center
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Kanagawa, Japão, 213-8587
- Recrutamento
- Toranomon Branch Hospital
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Kashiwa-shi, Japão, 277-8577
- Recrutamento
- National Cancer Center Hospital East
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Matsuyama, Japão, 791-0280
- Recrutamento
- National Hospital Organization Shikoku Cancer Center
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Numakunai, Japão, 028-3695
- Recrutamento
- Iwate Medical University Hospital
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Saitama, Japão, 362-0806
- Recrutamento
- Saitama Cancer Center
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Sakaishi, Japão, 591-8555
- Recrutamento
- NHO Kinki-Chuo Chest Medical Center
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Durango, México, 34000
- Ativo, não recrutando
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, México
- Ativo, não recrutando
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, México, 97070
- Concluído
- Medical Care & Research
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Gda?sk, Polônia, 80-214
- Recrutamento
- Uniwersyteckie Centrum Kliniczne
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Koszalin, Polônia, 75-581
- Recrutamento
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, Polônia, 02-781
- Recrutamento
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Leicester, Reino Unido, LE1 5WW
- Recrutamento
- Leicester Royal Infirmary
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Surrey, Reino Unido, SM2 5PT
- Concluído
- Royal Marsden Hospital - Surrey
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Moscow Oblast
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Moscow, Moscow Oblast, Rússia, 117997
- Ativo, não recrutando
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, Rússia, 125248
- Recrutamento
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, Rússia, 121205
- Recrutamento
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, Rússia, 119991
- Recrutamento
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Bangkok, Tailândia, 10700
- Recrutamento
- Siriraj Hospital
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Bangkok, Tailândia, 10330
- Ativo, não recrutando
- Chulalongkorn Hospital
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Chiang Mai, Tailândia, 50200
- Ativo, não recrutando
- Maharaj Nakorn Chiangmai Hospital
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Taichung, Taiwan, 407
- Recrutamento
- Taichung Veterans General Hospital
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Tainan, Taiwan, 70457
- Recrutamento
- National Cheng Kung University Hospital
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Taipei, Taiwan, 110
- Recrutamento
- National Taiwan University Hospital
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Taoyuan, Taiwan, 333
- Ativo, não recrutando
- Chang Gung Memorial Hospital - Linkou
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Kyiv, Ucrânia, 02000
- Recrutamento
- Arensia Exploratory Medicine - Ukraine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol OR
- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
- First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
- Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator
- Ability to comply with the extension study protocol, per Investigator's judgement
Exclusion Criteria:
- Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
- Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant
- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
- Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
- Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study. Potential participants with an ongoing SAE that has not resolved to baseline level or Grade 1 may be enrolled at the investigator's discretion, provided the event is deemed clinically stable and the investigator documents that the potential clinical benefit outweighs the risk to the potential participant.
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Roche IMP(s) Monotherapy
Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. |
Ipatasertib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.
Outros nomes:
Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Entrectinib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Giredestrant will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
|
|
Experimental: Roche Combined Agents
Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. |
Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.
Outros nomes:
Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Tiragolumab in combination with atezolizumab will be administered at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Tiragolumab and Atezolizumab in fixed dose combination administered intravenously (IV) at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
Giredestrant will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Número de participantes com acesso contínuo à terapia baseada em IMP(s) da Roche e/ou agente(s) de comparação
Prazo: Até aproximadamente 10 anos
|
Até aproximadamente 10 anos
|
|
Número e gravidade dos participantes com eventos adversos selecionados avaliados de acordo com os critérios de terminologia comum para eventos adversos do Instituto Nacional do Câncer (NCI CTCAE), versão 5.0
Prazo: Até aproximadamente 10 anos
|
Até aproximadamente 10 anos
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Clinical Trials, Hoffmann-La Roche
Publicações e 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
- BX44273
- 2022-003414-36 (Número EudraCT)
- 2023 (Concessão/Contrato do NIH dos EUA)
- 2023-504263-16-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .