En rollover-studie for deltakere som tidligere er registrert i en Genentech- og/eller F. Hoffman-La Roche-sponset studie (UmbrellaMAX)
En åpen, multisenter utvidelsesstudie i pasienter som tidligere er registrert i en Genentech og/eller F. Hoffmann-La Roche Ltd sponset studie
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. Only)
- E-post: global-roche-genentech-trials@gene.com
Studiesteder
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Charleroi, Belgia, 6060
- Fullført
- GHdC Site Les Viviers
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Kortrijk, Belgia, 8500
- Aktiv, ikke rekrutterende
- AZ Groeninge
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Leuven, Belgia, 3000
- Aktiv, ikke rekrutterende
- UZ Leuven Gasthuisberg
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Leuven, Belgia, 3000
- Fullført
- UZ Leuven Gasthuisberg
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Ontario
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Toronto, Ontario, Canada, M5G 1Z5
- Rekruttering
- Princess Margaret Cancer Center
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San José, Costa Rica, 10103
- Aktiv, ikke rekrutterende
- Clinica CIMCA
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San José, Costa Rica, 10108
- Aktiv, ikke rekrutterende
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bordeaux, Frankrike, 33076
- Rekruttering
- Institut Bergonie
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Caen, Frankrike, 14076
- Rekruttering
- Centre Francois Baclesse
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Dijon, Frankrike, 21000
- Rekruttering
- Institut de Cancérologie de Bourgogne
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Lyon, Frankrike, 69373
- Rekruttering
- Centre Leon Berard
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Marseille, Frankrike, 13005
- Rekruttering
- Hopital de la Timone
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Montpellier, Frankrike, 34298
- Rekruttering
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, Frankrike, 44093
- Rekruttering
- CHU de Nantes - Hotel Dieu
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Nîmes, Frankrike, 30029
- Fullført
- Institut de cancerologie du Gard
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Paris, Frankrike, 75005
- Rekruttering
- Institut Curie
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Paris, Frankrike, 75970
- Rekruttering
- Hopital Tenon
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Saint-Herblain, Frankrike, 44805
- Rekruttering
- ICO - Site René Gauducheau
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Toulouse, Frankrike, 31059
- Rekruttering
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, Frankrike, 54511
- Rekruttering
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, Frankrike, 94800
- Rekruttering
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankrike, 13005
- Rekruttering
- AP-HM- Hôpital de La Timone
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Asvestochóri, Hellas, 570 10
- Rekruttering
- General Hospital "G.Papanikolaou"
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Cholargós, Hellas, 155 62
- Rekruttering
- Metropolitan General Hospital
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Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, Japan, 810-8563
- Rekruttering
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japan, 812-8582
- Rekruttering
- Kyushu University Hospital
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Kanagawa, Japan, 232-0024
- Aktiv, ikke rekrutterende
- Yokohama City University Medical Center
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Kanagawa, Japan, 241-8515
- Fullført
- Kanagawa Cancer Center
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Kanagawa, Japan, 213-8587
- Rekruttering
- Toranomon Branch Hospital
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Kashiwa-shi, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East
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Matsuyama, Japan, 791-0280
- Rekruttering
- National Hospital Organization Shikoku Cancer Center
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Numakunai, Japan, 028-3695
- Rekruttering
- Iwate Medical University Hospital
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Saitama, Japan, 362-0806
- Rekruttering
- Saitama Cancer Center
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Sakaishi, Japan, 591-8555
- Rekruttering
- NHO Kinki-Chuo Chest Medical Center
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Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Changchun, Kina, 130021
- Rekruttering
- the First Hospital of Jilin University
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Chengdu, Kina, 610041
- Rekruttering
- West China Hospital of Sichuan University
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Guangzhou, Kina, 510515
- Rekruttering
- Nanfang Hospital, Southern Medical University
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Guangzhou, Kina, 510000
- Rekruttering
- Cancer Center of Guangzhou Medical University
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Hangzhou, Kina, 310022
- Rekruttering
- Zhejiang Cancer Hospital
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Hangzhou, Kina, 310014
- Rekruttering
- Zhejiang People's Hospital
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Hangzhou, Kina, 310016
- Rekruttering
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, Kina, 150081
- Rekruttering
- Harbin Medical University Cancer Hospital
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Hefei, Kina, 230601
- Rekruttering
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, Kina, 514031
- Rekruttering
- Meizhou People's Hospital
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Nanchang, Kina, 330052
- Rekruttering
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, Kina, 210029
- Rekruttering
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, Kina, 200030
- Rekruttering
- Shanghai Chest Hospital
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Shanghai, Kina, 200120
- Rekruttering
- Fudan University Shanghai Cancer Center
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Shanghai, Kina, 201104
- Rekruttering
- Shanghai Geriatric Medical Center
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Tianjin, Kina, 300060
- Rekruttering
- Tianjin Cancer Hospital
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Xi'an, Kina, 710061
- Rekruttering
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, Kina, 710126
- Rekruttering
- Xi'an International Medical Center Hospital
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Xiamen, Kina, 361003
- Rekruttering
- The First Affiliated Hospital of Xiamen University
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Xinxiang, Kina
- Rekruttering
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, Kina, 450008
- Rekruttering
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Kina, 430048
- Rekruttering
- 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, Kina, 710061
- Rekruttering
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center
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Durango, Mexico, 34000
- Aktiv, ikke rekrutterende
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, Mexico
- Aktiv, ikke rekrutterende
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, Mexico, 97070
- Fullført
- Medical Care & Research
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Gda?sk, Polen, 80-214
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
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Koszalin, Polen, 75-581
- Rekruttering
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, Polen, 02-781
- Rekruttering
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Moscow Oblast
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Moscow, Moscow Oblast, Russland, 117997
- Aktiv, ikke rekrutterende
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, Russland, 125248
- Rekruttering
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, Russland, 121205
- Rekruttering
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, Russland, 119991
- Rekruttering
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Leicester, Storbritannia, LE1 5WW
- Rekruttering
- Leicester Royal Infirmary
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Surrey, Storbritannia, SM2 5PT
- Fullført
- Royal Marsden Hospital - Surrey
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Goyang-si, Sør -Korea, 10408
- Rekruttering
- National Cancer Center
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Gyeonggi-do, Sør -Korea, 13496
- Rekruttering
- CHA Bundang Medical Center
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Seongnam-si, Sør -Korea, 463-707
- Fullført
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center
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Seoul, Sør -Korea, 05505
- Aktiv, ikke rekrutterende
- Asan Medical Center
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Taichung, Taiwan, 407
- Rekruttering
- Taichung Veterans General Hospital
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Tainan, Taiwan, 70457
- Rekruttering
- National Cheng Kung University Hospital
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Taipei, Taiwan, 110
- Rekruttering
- National Taiwan University Hospital
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Taoyuan, Taiwan, 333
- Aktiv, ikke rekrutterende
- Chang Gung Memorial Hospital - Linkou
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Bangkok, Thailand, 10700
- Rekruttering
- Siriraj Hospital
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Bangkok, Thailand, 10330
- Aktiv, ikke rekrutterende
- Chulalongkorn Hospital
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Chiang Mai, Thailand, 50200
- Aktiv, ikke rekrutterende
- Maharaj Nakorn Chiangmai Hospital
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Kyiv, Ukraina, 02000
- Rekruttering
- Arensia Exploratory Medicine - Ukraine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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Eksperimentell: 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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Antall deltakere med fortsatt tilgang til Roche IMP(er)-basert terapi og/eller sammenligningsagent(er)
Tidsramme: Opptil ca 10 år
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Opptil ca 10 år
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Antall og alvorlighetsgrad av deltakere med utvalgte uønskede hendelser vurdert i henhold til National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), versjon 5.0
Tidsramme: Opptil ca 10 år
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Opptil ca 10 år
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BX44273
- 2022-003414-36 (EudraCT-nummer)
- 2023 (U.S. NIH-stipend/kontrakt)
- 2023-504263-16-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .