Een doorlopende studie voor deelnemers die eerder deelnamen aan een door Genentech en/of F. Hoffman-La Roche gesponsord onderzoek (UmbrellaMAX)
Een open-label, multicenter extensieonderzoek bij patiënten die eerder deelnamen aan een door Genentech en/of door F. Hoffmann-La Roche Ltd gesponsord onderzoek
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studie Contact Back-up
- Naam: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- Telefoonnummer: 888-662-6728 (U.S. Only)
- E-mail: global-roche-genentech-trials@gene.com
Studie Locaties
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Charleroi, België, 6060
- Voltooid
- GHdC Site Les Viviers
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Kortrijk, België, 8500
- Actief, niet wervend
- AZ Groeninge
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Leuven, België, 3000
- Actief, niet wervend
- UZ Leuven Gasthuisberg
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Leuven, België, 3000
- Voltooid
- UZ Leuven Gasthuisberg
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Ontario
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Toronto, Ontario, Canada, M5G 1Z5
- Werving
- Princess Margaret Cancer Center
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Beijing, China, 100142
- Werving
- Beijing Cancer Hospital
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Changchun, China, 130021
- Werving
- the First Hospital of Jilin University
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Chengdu, China, 610041
- Werving
- West China Hospital of Sichuan University
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Guangzhou, China, 510515
- Werving
- Nanfang Hospital, Southern Medical University
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Guangzhou, China, 510000
- Werving
- Cancer Center of Guangzhou Medical University
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Hangzhou, China, 310022
- Werving
- Zhejiang Cancer Hospital
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Hangzhou, China, 310014
- Werving
- Zhejiang People's Hospital
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Hangzhou, China, 310016
- Werving
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, China, 150081
- Werving
- Harbin Medical University Cancer Hospital
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Hefei, China, 230601
- Werving
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, China, 514031
- Werving
- Meizhou People's Hospital
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Nanchang, China, 330052
- Werving
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, China, 210029
- Werving
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, China, 200030
- Werving
- Shanghai Chest Hospital
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Shanghai, China, 200120
- Werving
- Fudan University Shanghai Cancer Center
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Shanghai, China, 201104
- Werving
- Shanghai Geriatric Medical Center
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Tianjin, China, 300060
- Werving
- Tianjin Cancer Hospital
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Xi'an, China, 710061
- Werving
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, China, 710126
- Werving
- Xi'an International Medical Center Hospital
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Xiamen, China, 361003
- Werving
- The First Affiliated Hospital of Xiamen University
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Xinxiang, China
- Werving
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, China, 450008
- Werving
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, China, 430048
- Werving
- 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
- Werving
- 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
- Werving
- Fudan University Shanghai Cancer Center
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San José, Costa Rica, 10103
- Actief, niet wervend
- Clinica CIMCA
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San José, Costa Rica, 10108
- Actief, niet wervend
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bordeaux, Frankrijk, 33076
- Werving
- Institut Bergonie
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Caen, Frankrijk, 14076
- Werving
- Centre Francois Baclesse
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Dijon, Frankrijk, 21000
- Werving
- Institut de Cancérologie de Bourgogne
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Lyon, Frankrijk, 69373
- Werving
- Centre Leon Berard
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Marseille, Frankrijk, 13005
- Werving
- Hopital de la Timone
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Montpellier, Frankrijk, 34298
- Werving
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, Frankrijk, 44093
- Werving
- CHU de Nantes - Hotel Dieu
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Nîmes, Frankrijk, 30029
- Voltooid
- Institut de cancerologie du Gard
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Paris, Frankrijk, 75005
- Werving
- Institut Curie
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Paris, Frankrijk, 75970
- Werving
- Hopital Tenon
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Saint-Herblain, Frankrijk, 44805
- Werving
- ICO - Site René Gauducheau
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Toulouse, Frankrijk, 31059
- Werving
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, Frankrijk, 54511
- Werving
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, Frankrijk, 94800
- Werving
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankrijk, 13005
- Werving
- AP-HM- Hôpital de La Timone
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Asvestochóri, Griekenland, 570 10
- Werving
- General Hospital "G.Papanikolaou"
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Cholargós, Griekenland, 155 62
- Werving
- Metropolitan General Hospital
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Chiba, Japan, 277-8577
- Werving
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, Japan, 810-8563
- Werving
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japan, 812-8582
- Werving
- Kyushu University Hospital
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Kanagawa, Japan, 232-0024
- Actief, niet wervend
- Yokohama City University Medical Center
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Kanagawa, Japan, 241-8515
- Voltooid
- Kanagawa Cancer Center
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Kanagawa, Japan, 213-8587
- Werving
- Toranomon Branch Hospital
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Kashiwa-shi, Japan, 277-8577
- Werving
- National Cancer Center Hospital East
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Matsuyama, Japan, 791-0280
- Werving
- National Hospital Organization Shikoku Cancer Center
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Numakunai, Japan, 028-3695
- Werving
- Iwate Medical University Hospital
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Saitama, Japan, 362-0806
- Werving
- Saitama Cancer Center
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Sakaishi, Japan, 591-8555
- Werving
- NHO Kinki-Chuo Chest Medical Center
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Durango, Mexico, 34000
- Actief, niet wervend
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, Mexico
- Actief, niet wervend
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, Mexico, 97070
- Voltooid
- Medical Care & Research
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Kyiv, Oekraïne, 02000
- Werving
- Arensia Exploratory Medicine - Ukraine
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Gda?sk, Polen, 80-214
- Werving
- Uniwersyteckie Centrum Kliniczne
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Koszalin, Polen, 75-581
- Werving
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, Polen, 02-781
- Werving
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Moscow Oblast
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Moscow, Moscow Oblast, Rusland, 117997
- Actief, niet wervend
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, Rusland, 125248
- Werving
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, Rusland, 121205
- Werving
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, Rusland, 119991
- Werving
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Taichung, Taiwan, 407
- Werving
- Taichung Veterans General Hospital
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Tainan, Taiwan, 70457
- Werving
- National Cheng Kung University Hospital
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Taipei, Taiwan, 110
- Werving
- National Taiwan University Hospital
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Taoyuan, Taiwan, 333
- Actief, niet wervend
- Chang Gung Memorial Hospital - Linkou
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Bangkok, Thailand, 10700
- Werving
- Siriraj Hospital
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Bangkok, Thailand, 10330
- Actief, niet wervend
- Chulalongkorn Hospital
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Chiang Mai, Thailand, 50200
- Actief, niet wervend
- Maharaj Nakorn Chiangmai Hospital
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Leicester, Verenigd Koninkrijk, LE1 5WW
- Werving
- Leicester Royal Infirmary
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Surrey, Verenigd Koninkrijk, SM2 5PT
- Voltooid
- Royal Marsden Hospital - Surrey
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Goyang-si, Zuid -Korea, 10408
- Werving
- National Cancer Center
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Gyeonggi-do, Zuid -Korea, 13496
- Werving
- CHA Bundang Medical Center
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Seongnam-si, Zuid -Korea, 463-707
- Voltooid
- Seoul National University Bundang Hospital
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Seoul, Zuid -Korea, 06351
- Werving
- Samsung Medical Center
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Seoul, Zuid -Korea, 05505
- Actief, niet wervend
- Asan Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Aantal deelnemers met blijvende toegang tot Roche IMP(s)-gebaseerde therapie en/of vergelijkende agent(en)
Tijdsspanne: Tot ongeveer 10 jaar
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Tot ongeveer 10 jaar
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Aantal en ernst van deelnemers met geselecteerde bijwerkingen beoordeeld volgens de Common Terminology Criteria for Adverse Events (NCI CTCAE), versie 5.0 van het National Cancer Institute
Tijdsspanne: Tot ongeveer 10 jaar
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Tot ongeveer 10 jaar
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Clinical Trials, Hoffmann-La Roche
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BX44273
- 2022-003414-36 (EudraCT-nummer)
- 2023 (Subsidie/contract van de Amerikaanse NIH)
- 2023-504263-16-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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