Une étude de reconduction pour les participants précédemment inscrits à une étude parrainée par Genentech et/ou F. Hoffman-La Roche (UmbrellaMAX)
Une étude d'extension multicentrique ouverte chez des patients précédemment inscrits à une étude parrainée par Genentech et/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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sauvegarde des contacts de l'étude
- Nom: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- Numéro de téléphone: 888-662-6728 (U.S. Only)
- E-mail: global-roche-genentech-trials@gene.com
Lieux d'étude
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Charleroi, Belgique, 6060
- Complété
- GHdC Site Les Viviers
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Kortrijk, Belgique, 8500
- Actif, ne recrute pas
- AZ Groeninge
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Leuven, Belgique, 3000
- Actif, ne recrute pas
- UZ Leuven Gasthuisberg
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Leuven, Belgique, 3000
- Complété
- UZ Leuven Gasthuisberg
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Ontario
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Toronto, Ontario, Canada, M5G 1Z5
- Recrutement
- Princess Margaret Cancer Center
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Beijing, Chine, 100142
- Recrutement
- Beijing Cancer Hospital
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Changchun, Chine, 130021
- Recrutement
- the First Hospital of Jilin University
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Chengdu, Chine, 610041
- Recrutement
- West China Hospital of Sichuan University
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Guangzhou, Chine, 510515
- Recrutement
- Nanfang Hospital, Southern Medical University
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Guangzhou, Chine, 510000
- Recrutement
- Cancer Center of Guangzhou Medical University
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Hangzhou, Chine, 310022
- Recrutement
- Zhejiang Cancer Hospital
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Hangzhou, Chine, 310014
- Recrutement
- Zhejiang People's Hospital
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Hangzhou, Chine, 310016
- Recrutement
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, Chine, 150081
- Recrutement
- Harbin Medical University Cancer Hospital
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Hefei, Chine, 230601
- Recrutement
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, Chine, 514031
- Recrutement
- Meizhou People's Hospital
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Nanchang, Chine, 330052
- Recrutement
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, Chine, 210029
- Recrutement
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, Chine, 200030
- Recrutement
- Shanghai Chest Hospital
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Shanghai, Chine, 200120
- Recrutement
- Fudan University Shanghai Cancer Center
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Shanghai, Chine, 201104
- Recrutement
- Shanghai Geriatric Medical Center
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Tianjin, Chine, 300060
- Recrutement
- Tianjin Cancer Hospital
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Xi'an, Chine, 710061
- Recrutement
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, Chine, 710126
- Recrutement
- Xi'an International Medical Center Hospital
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Xiamen, Chine, 361003
- Recrutement
- The First Affiliated Hospital of Xiamen University
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Xinxiang, Chine
- Recrutement
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, Chine, 450008
- Recrutement
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Chine, 430048
- Recrutement
- 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, Chine, 710061
- Recrutement
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200032
- Recrutement
- Fudan University Shanghai Cancer Center
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Goyang-si, Corée du Sud, 10408
- Recrutement
- National Cancer Center
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Gyeonggi-do, Corée du Sud, 13496
- Recrutement
- CHA Bundang Medical Center
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Seongnam-si, Corée du Sud, 463-707
- Complété
- Seoul National University Bundang Hospital
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Seoul, Corée du Sud, 06351
- Recrutement
- Samsung Medical Center
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Seoul, Corée du Sud, 05505
- Actif, ne recrute pas
- Asan Medical Center
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San José, Costa Rica, 10103
- Actif, ne recrute pas
- Clinica CIMCA
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San José, Costa Rica, 10108
- Actif, ne recrute pas
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bordeaux, France, 33076
- Recrutement
- Institut Bergonie
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Caen, France, 14076
- Recrutement
- Centre Francois Baclesse
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Dijon, France, 21000
- Recrutement
- Institut de Cancérologie de Bourgogne
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Lyon, France, 69373
- Recrutement
- Centre Leon Berard
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Marseille, France, 13005
- Recrutement
- Hopital de la Timone
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Montpellier, France, 34298
- Recrutement
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, France, 44093
- Recrutement
- CHU de Nantes - Hotel Dieu
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Nîmes, France, 30029
- Complété
- Institut de cancerologie du Gard
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Paris, France, 75005
- Recrutement
- Institut Curie
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Paris, France, 75970
- Recrutement
- Hopital Tenon
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Saint-Herblain, France, 44805
- Recrutement
- ICO - Site René Gauducheau
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Toulouse, France, 31059
- Recrutement
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, France, 54511
- Recrutement
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, France, 94800
- Recrutement
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, France, 13005
- Recrutement
- AP-HM- Hôpital de La Timone
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Asvestochóri, Grèce, 570 10
- Recrutement
- General Hospital "G.Papanikolaou"
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Cholargós, Grèce, 155 62
- Recrutement
- Metropolitan General Hospital
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Chiba, Japon, 277-8577
- Recrutement
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, Japon, 810-8563
- Recrutement
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japon, 812-8582
- Recrutement
- Kyushu University Hospital
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Kanagawa, Japon, 232-0024
- Actif, ne recrute pas
- Yokohama City University Medical Center
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Kanagawa, Japon, 241-8515
- Complété
- Kanagawa Cancer Center
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Kanagawa, Japon, 213-8587
- Recrutement
- Toranomon Branch Hospital
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Kashiwa-shi, Japon, 277-8577
- Recrutement
- National Cancer Center Hospital East
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Matsuyama, Japon, 791-0280
- Recrutement
- National Hospital Organization Shikoku Cancer Center
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Numakunai, Japon, 028-3695
- Recrutement
- Iwate Medical University Hospital
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Saitama, Japon, 362-0806
- Recrutement
- Saitama Cancer Center
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Sakaishi, Japon, 591-8555
- Recrutement
- NHO Kinki-Chuo Chest Medical Center
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Durango, Mexique, 34000
- Actif, ne recrute pas
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, Mexique
- Actif, ne recrute pas
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, Mexique, 97070
- Complété
- Medical Care & Research
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Gda?sk, Pologne, 80-214
- Recrutement
- Uniwersyteckie Centrum Kliniczne
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Koszalin, Pologne, 75-581
- Recrutement
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, Pologne, 02-781
- Recrutement
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Leicester, Royaume-Uni, LE1 5WW
- Recrutement
- Leicester Royal Infirmary
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Surrey, Royaume-Uni, SM2 5PT
- Complété
- Royal Marsden Hospital - Surrey
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Moscow Oblast
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Moscow, Moscow Oblast, Russie, 117997
- Actif, ne recrute pas
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, Russie, 125248
- Recrutement
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, Russie, 121205
- Recrutement
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, Russie, 119991
- Recrutement
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Taichung, Taïwan, 407
- Recrutement
- Taichung Veterans General Hospital
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Tainan, Taïwan, 70457
- Recrutement
- National Cheng Kung University Hospital
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Taipei, Taïwan, 110
- Recrutement
- National Taiwan University Hospital
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Taoyuan, Taïwan, 333
- Actif, ne recrute pas
- Chang Gung Memorial Hospital - Linkou
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Bangkok, Thaïlande, 10700
- Recrutement
- Siriraj Hospital
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Bangkok, Thaïlande, 10330
- Actif, ne recrute pas
- Chulalongkorn Hospital
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Chiang Mai, Thaïlande, 50200
- Actif, ne recrute pas
- Maharaj Nakorn Chiangmai Hospital
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Kyiv, Ukraine, 02000
- Recrutement
- Arensia Exploratory Medicine - Ukraine
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Nombre de participants ayant un accès continu à la thérapie à base de Roche IMP(s) et/ou à un ou plusieurs agents de comparaison
Délai: Jusqu'à environ 10 ans
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Jusqu'à environ 10 ans
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|
Nombre et gravité des participants présentant des événements indésirables sélectionnés évalués selon les critères de terminologie communs pour les événements indésirables du National Cancer Institute (NCI CTCAE), version 5.0
Délai: Jusqu'à environ 10 ans
|
Jusqu'à environ 10 ans
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Trials, Hoffmann-La Roche
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BX44273
- 2022-003414-36 (Numéro EudraCT)
- 2023 (Subvention/contrat des NIH des États-Unis)
- 2023-504263-16-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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