Un estudio de transferencia para participantes previamente inscritos en un estudio patrocinado por Genentech y/o F. Hoffman-La Roche (UmbrellaMAX)
Un estudio de extensión multicéntrico de etiqueta abierta en pacientes previamente inscritos en un estudio patrocinado por Genentech y/o 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Copia de seguridad de contactos de estudio
- Nombre: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- Número de teléfono: 888-662-6728 (U.S. Only)
- Correo electrónico: global-roche-genentech-trials@gene.com
Ubicaciones de estudio
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Charleroi, Bélgica, 6060
- Terminado
- GHdC Site Les Viviers
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Kortrijk, Bélgica, 8500
- Activo, no reclutando
- AZ Groeninge
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Leuven, Bélgica, 3000
- Activo, no reclutando
- UZ Leuven Gasthuisberg
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Leuven, Bélgica, 3000
- Terminado
- UZ Leuven Gasthuisberg
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Ontario
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Toronto, Ontario, Canadá, M5G 1Z5
- Reclutamiento
- Princess Margaret Cancer Center
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Goyang-si, Corea del Sur, 10408
- Reclutamiento
- National Cancer Center
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Gyeonggi-do, Corea del Sur, 13496
- Reclutamiento
- CHA Bundang Medical Center
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Seongnam-si, Corea del Sur, 463-707
- Terminado
- Seoul National University Bundang Hospital
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Seoul, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center
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Seoul, Corea del Sur, 05505
- Activo, no reclutando
- Asan Medical Center
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San José, Costa Rica, 10103
- Activo, no reclutando
- Clinica CIMCA
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San José, Costa Rica, 10108
- Activo, no reclutando
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bordeaux, Francia, 33076
- Reclutamiento
- Institut Bergonie
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Caen, Francia, 14076
- Reclutamiento
- Centre Francois Baclesse
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Dijon, Francia, 21000
- Reclutamiento
- Institut de Cancérologie de Bourgogne
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Lyon, Francia, 69373
- Reclutamiento
- Centre Leon Berard
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Marseille, Francia, 13005
- Reclutamiento
- Hopital de la Timone
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Montpellier, Francia, 34298
- Reclutamiento
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, Francia, 44093
- Reclutamiento
- CHU de Nantes - Hotel Dieu
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Nîmes, Francia, 30029
- Terminado
- Institut de cancerologie du Gard
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Paris, Francia, 75005
- Reclutamiento
- Institut Curie
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Paris, Francia, 75970
- Reclutamiento
- Hopital Tenon
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Saint-Herblain, Francia, 44805
- Reclutamiento
- ICO - Site René Gauducheau
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Toulouse, Francia, 31059
- Reclutamiento
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, Francia, 54511
- Reclutamiento
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, Francia, 94800
- Reclutamiento
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Francia, 13005
- Reclutamiento
- AP-HM- Hôpital de La Timone
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Asvestochóri, Grecia, 570 10
- Reclutamiento
- General Hospital "G.Papanikolaou"
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Cholargós, Grecia, 155 62
- Reclutamiento
- Metropolitan General Hospital
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Chiba, Japón, 277-8577
- Reclutamiento
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, Japón, 810-8563
- Reclutamiento
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japón, 812-8582
- Reclutamiento
- Kyushu University Hospital
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Kanagawa, Japón, 232-0024
- Activo, no reclutando
- Yokohama City University Medical Center
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Kanagawa, Japón, 241-8515
- Terminado
- Kanagawa Cancer Center
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Kanagawa, Japón, 213-8587
- Reclutamiento
- Toranomon Branch Hospital
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Kashiwa-shi, Japón, 277-8577
- Reclutamiento
- National Cancer Center Hospital East
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Matsuyama, Japón, 791-0280
- Reclutamiento
- National Hospital Organization Shikoku Cancer Center
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Numakunai, Japón, 028-3695
- Reclutamiento
- Iwate Medical University Hospital
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Saitama, Japón, 362-0806
- Reclutamiento
- Saitama Cancer Center
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Sakaishi, Japón, 591-8555
- Reclutamiento
- NHO Kinki-Chuo Chest Medical Center
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Durango, México, 34000
- Activo, no reclutando
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, México
- Activo, no reclutando
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, México, 97070
- Terminado
- Medical Care & Research
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Gda?sk, Polonia, 80-214
- Reclutamiento
- Uniwersyteckie Centrum Kliniczne
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Koszalin, Polonia, 75-581
- Reclutamiento
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, Polonia, 02-781
- Reclutamiento
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Beijing, Porcelana, 100142
- Reclutamiento
- Beijing Cancer Hospital
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Changchun, Porcelana, 130021
- Reclutamiento
- the First Hospital of Jilin University
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Chengdu, Porcelana, 610041
- Reclutamiento
- West China Hospital of Sichuan University
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Guangzhou, Porcelana, 510515
- Reclutamiento
- Nanfang Hospital, Southern Medical University
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Guangzhou, Porcelana, 510000
- Reclutamiento
- Cancer Center of Guangzhou Medical University
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Hangzhou, Porcelana, 310022
- Reclutamiento
- Zhejiang Cancer Hospital
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Hangzhou, Porcelana, 310014
- Reclutamiento
- Zhejiang People's Hospital
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Hangzhou, Porcelana, 310016
- Reclutamiento
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, Porcelana, 150081
- Reclutamiento
- Harbin Medical University Cancer Hospital
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Hefei, Porcelana, 230601
- Reclutamiento
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, Porcelana, 514031
- Reclutamiento
- Meizhou People's Hospital
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Nanchang, Porcelana, 330052
- Reclutamiento
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, Porcelana, 210029
- Reclutamiento
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, Porcelana, 200030
- Reclutamiento
- Shanghai Chest Hospital
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Shanghai, Porcelana, 200120
- Reclutamiento
- Fudan University Shanghai Cancer Center
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Shanghai, Porcelana, 201104
- Reclutamiento
- Shanghai Geriatric Medical Center
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Tianjin, Porcelana, 300060
- Reclutamiento
- Tianjin Cancer Hospital
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Xi'an, Porcelana, 710061
- Reclutamiento
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, Porcelana, 710126
- Reclutamiento
- Xi'an International Medical Center Hospital
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Xiamen, Porcelana, 361003
- Reclutamiento
- The First Affiliated Hospital of Xiamen University
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Xinxiang, Porcelana
- Reclutamiento
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, Porcelana, 450008
- Reclutamiento
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Porcelana, 430048
- Reclutamiento
- 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, Porcelana, 710061
- Reclutamiento
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Reclutamiento
- Fudan University Shanghai Cancer Center
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Leicester, Reino Unido, LE1 5WW
- Reclutamiento
- Leicester Royal Infirmary
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Surrey, Reino Unido, SM2 5PT
- Terminado
- Royal Marsden Hospital - Surrey
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Moscow Oblast
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Moscow, Moscow Oblast, Rusia, 117997
- Activo, no reclutando
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, Rusia, 125248
- Reclutamiento
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, Rusia, 121205
- Reclutamiento
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, Rusia, 119991
- Reclutamiento
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Bangkok, Tailandia, 10700
- Reclutamiento
- Siriraj Hospital
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Bangkok, Tailandia, 10330
- Activo, no reclutando
- Chulalongkorn Hospital
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Chiang Mai, Tailandia, 50200
- Activo, no reclutando
- Maharaj Nakorn Chiangmai Hospital
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Taichung, Taiwán, 407
- Reclutamiento
- Taichung Veterans General Hospital
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Tainan, Taiwán, 70457
- Reclutamiento
- National Cheng Kung University Hospital
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Taipei, Taiwán, 110
- Reclutamiento
- National Taiwan University Hospital
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Taoyuan, Taiwán, 333
- Activo, no reclutando
- Chang Gung Memorial Hospital - Linkou
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Kyiv, Ucrania, 02000
- Reclutamiento
- Arensia Exploratory Medicine - Ukraine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
|
|
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Número de participantes con acceso continuo a la terapia basada en IMP(s) de Roche y/o agente(s) de comparación
Periodo de tiempo: Hasta aproximadamente 10 años
|
Hasta aproximadamente 10 años
|
|
Número y gravedad de participantes con eventos adversos seleccionados evaluados según los Criterios de terminología común para eventos adversos del Instituto Nacional del Cáncer (NCI CTCAE), versión 5.0
Periodo de tiempo: Hasta 10 años aproximadamente
|
Hasta 10 años aproximadamente
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BX44273
- 2022-003414-36 (Número EudraCT)
- 2023 (Subvención/contrato del NIH de EE. UU.)
- 2023-504263-16-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .