Uno studio di rollover per i partecipanti precedentemente iscritti a uno studio sponsorizzato da Genentech e/o F. Hoffman-La Roche (UmbrellaMAX)
Uno studio di estensione multicentrico in aperto su pazienti precedentemente arruolati in uno studio sponsorizzato da Genentech e/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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Backup dei contatti dello studio
- Nome: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- Numero di telefono: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Luoghi di studio
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Charleroi, Belgio, 6060
- Completato
- GHdC Site Les Viviers
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Kortrijk, Belgio, 8500
- Attivo, non reclutante
- AZ Groeninge
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Leuven, Belgio, 3000
- Attivo, non reclutante
- UZ Leuven Gasthuisberg
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Leuven, Belgio, 3000
- Completato
- UZ Leuven Gasthuisberg
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Ontario
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Toronto, Ontario, Canada, M5G 1Z5
- Reclutamento
- Princess Margaret Cancer Center
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Beijing, Cina, 100142
- Reclutamento
- Beijing Cancer Hospital
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Changchun, Cina, 130021
- Reclutamento
- the First Hospital of Jilin University
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Chengdu, Cina, 610041
- Reclutamento
- West China Hospital of Sichuan University
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Guangzhou, Cina, 510515
- Reclutamento
- Nanfang Hospital, Southern Medical University
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Guangzhou, Cina, 510000
- Reclutamento
- Cancer Center of Guangzhou Medical University
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Hangzhou, Cina, 310022
- Reclutamento
- Zhejiang Cancer Hospital
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Hangzhou, Cina, 310014
- Reclutamento
- Zhejiang People's Hospital
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Hangzhou, Cina, 310016
- Reclutamento
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, Cina, 150081
- Reclutamento
- Harbin Medical University Cancer Hospital
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Hefei, Cina, 230601
- Reclutamento
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, Cina, 514031
- Reclutamento
- Meizhou People's Hospital
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Nanchang, Cina, 330052
- Reclutamento
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, Cina, 210029
- Reclutamento
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, Cina, 200030
- Reclutamento
- Shanghai Chest Hospital
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Shanghai, Cina, 200120
- Reclutamento
- Fudan University Shanghai Cancer Center
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Shanghai, Cina, 201104
- Reclutamento
- Shanghai Geriatric Medical Center
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Tianjin, Cina, 300060
- Reclutamento
- Tianjin Cancer Hospital
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Xi'an, Cina, 710061
- Reclutamento
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, Cina, 710126
- Reclutamento
- Xi'an International Medical Center Hospital
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Xiamen, Cina, 361003
- Reclutamento
- The First Affiliated Hospital of Xiamen University
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Xinxiang, Cina
- Reclutamento
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, Cina, 450008
- Reclutamento
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Cina, 430048
- Reclutamento
- 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, Cina, 710061
- Reclutamento
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200032
- Reclutamento
- Fudan University Shanghai Cancer Center
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Goyang-si, Corea del Sud, 10408
- Reclutamento
- National Cancer Center
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Gyeonggi-do, Corea del Sud, 13496
- Reclutamento
- CHA Bundang Medical Center
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Seongnam-si, Corea del Sud, 463-707
- Completato
- Seoul National University Bundang Hospital
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Seoul, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center
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Seoul, Corea del Sud, 05505
- Attivo, non reclutante
- Asan Medical Center
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San José, Costa Rica, 10103
- Attivo, non reclutante
- Clinica CIMCA
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San José, Costa Rica, 10108
- Attivo, non reclutante
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bordeaux, Francia, 33076
- Reclutamento
- Institut Bergonie
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Caen, Francia, 14076
- Reclutamento
- Centre Francois Baclesse
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Dijon, Francia, 21000
- Reclutamento
- Institut de Cancérologie de Bourgogne
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Lyon, Francia, 69373
- Reclutamento
- Centre Leon Berard
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Marseille, Francia, 13005
- Reclutamento
- Hopital de la Timone
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Montpellier, Francia, 34298
- Reclutamento
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, Francia, 44093
- Reclutamento
- CHU de Nantes - Hotel Dieu
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Nîmes, Francia, 30029
- Completato
- Institut de cancerologie du Gard
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Paris, Francia, 75005
- Reclutamento
- Institut Curie
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Paris, Francia, 75970
- Reclutamento
- Hopital Tenon
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Saint-Herblain, Francia, 44805
- Reclutamento
- ICO - Site René Gauducheau
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Toulouse, Francia, 31059
- Reclutamento
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, Francia, 54511
- Reclutamento
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, Francia, 94800
- Reclutamento
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Francia, 13005
- Reclutamento
- AP-HM- Hôpital de La Timone
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Chiba, Giappone, 277-8577
- Reclutamento
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, Giappone, 810-8563
- Reclutamento
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Giappone, 812-8582
- Reclutamento
- Kyushu University Hospital
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Kanagawa, Giappone, 232-0024
- Attivo, non reclutante
- Yokohama City University Medical Center
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Kanagawa, Giappone, 241-8515
- Completato
- Kanagawa Cancer Center
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Kanagawa, Giappone, 213-8587
- Reclutamento
- Toranomon Branch Hospital
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Kashiwa-shi, Giappone, 277-8577
- Reclutamento
- National Cancer Center Hospital East
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Matsuyama, Giappone, 791-0280
- Reclutamento
- National Hospital Organization Shikoku Cancer Center
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Numakunai, Giappone, 028-3695
- Reclutamento
- Iwate Medical University Hospital
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Saitama, Giappone, 362-0806
- Reclutamento
- Saitama Cancer Center
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Sakaishi, Giappone, 591-8555
- Reclutamento
- NHO Kinki-Chuo Chest Medical Center
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Asvestochóri, Grecia, 570 10
- Reclutamento
- General Hospital "G.Papanikolaou"
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Cholargós, Grecia, 155 62
- Reclutamento
- Metropolitan General Hospital
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Durango, Messico, 34000
- Attivo, non reclutante
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, Messico
- Attivo, non reclutante
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, Messico, 97070
- Completato
- Medical Care & Research
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Gda?sk, Polonia, 80-214
- Reclutamento
- Uniwersyteckie Centrum Kliniczne
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Koszalin, Polonia, 75-581
- Reclutamento
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, Polonia, 02-781
- Reclutamento
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Leicester, Regno Unito, LE1 5WW
- Reclutamento
- Leicester Royal Infirmary
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Surrey, Regno Unito, SM2 5PT
- Completato
- Royal Marsden Hospital - Surrey
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Moscow Oblast
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Moscow, Moscow Oblast, Russia, 117997
- Attivo, non reclutante
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, Russia, 125248
- Reclutamento
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, Russia, 121205
- Reclutamento
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, Russia, 119991
- Reclutamento
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Bangkok, Tailandia, 10700
- Reclutamento
- Siriraj Hospital
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Bangkok, Tailandia, 10330
- Attivo, non reclutante
- Chulalongkorn Hospital
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Chiang Mai, Tailandia, 50200
- Attivo, non reclutante
- Maharaj Nakorn Chiangmai Hospital
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Taichung, Taiwan, 407
- Reclutamento
- Taichung Veterans General Hospital
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Tainan, Taiwan, 70457
- Reclutamento
- National Cheng Kung University Hospital
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Taipei, Taiwan, 110
- Reclutamento
- National Taiwan University Hospital
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Taoyuan, Taiwan, 333
- Attivo, non reclutante
- Chang Gung Memorial Hospital - Linkou
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Kyiv, Ucraina, 02000
- Reclutamento
- Arensia Exploratory Medicine - Ukraine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Numero di partecipanti con accesso continuato alla terapia basata su IMP Roche e/o agli agenti di confronto
Lasso di tempo: Fino a circa 10 anni
|
Fino a circa 10 anni
|
|
Numero e gravità dei partecipanti con eventi avversi selezionati valutati secondo i criteri comuni di terminologia per gli eventi avversi del National Cancer Institute (NCI CTCAE), versione 5.0
Lasso di tempo: Fino a circa 10 anni
|
Fino a circa 10 anni
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Clinical Trials, Hoffmann-La Roche
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BX44273
- 2022-003414-36 (Numero EudraCT)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
- 2023-504263-16-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .