Rollover-tutkimus osallistujille, jotka ovat aiemmin ilmoittautuneet Genentechin ja/tai F. Hoffman-La Rochen sponsoroimaan tutkimukseen (UmbrellaMAX)
Avoin monikeskustutkimus potilailla, jotka ovat aiemmin ilmoittautuneet Genentechin ja/tai F. Hoffmann-La Roche Ltd:n sponsoroimaan tutkimukseen
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Tutki yhteystietojen varmuuskopiointi
- Nimi: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- Puhelinnumero: 888-662-6728 (U.S. Only)
- Sähköposti: global-roche-genentech-trials@gene.com
Opiskelupaikat
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Charleroi, Belgia, 6060
- Valmis
- GHdC Site Les Viviers
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Kortrijk, Belgia, 8500
- Aktiivinen, ei rekrytointi
- AZ Groeninge
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Leuven, Belgia, 3000
- Aktiivinen, ei rekrytointi
- UZ Leuven Gasthuisberg
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Leuven, Belgia, 3000
- Valmis
- UZ Leuven Gasthuisberg
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San José, Costa Rica, 10103
- Aktiivinen, ei rekrytointi
- Clinica CIMCA
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San José, Costa Rica, 10108
- Aktiivinen, ei rekrytointi
- ICIMED Instituto de Investigación en Ciencias Médicas
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Goyang-si, Etelä -Korea, 10408
- Rekrytointi
- National Cancer Center
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Gyeonggi-do, Etelä -Korea, 13496
- Rekrytointi
- CHA Bundang Medical Center
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Seongnam-si, Etelä -Korea, 463-707
- Valmis
- Seoul National University Bundang Hospital
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Seoul, Etelä -Korea, 06351
- Rekrytointi
- Samsung Medical Center
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Seoul, Etelä -Korea, 05505
- Aktiivinen, ei rekrytointi
- Asan Medical Center
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Chiba, Japani, 277-8577
- Rekrytointi
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, Japani, 810-8563
- Rekrytointi
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japani, 812-8582
- Rekrytointi
- Kyushu University Hospital
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Kanagawa, Japani, 232-0024
- Aktiivinen, ei rekrytointi
- Yokohama City University Medical Center
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Kanagawa, Japani, 241-8515
- Valmis
- Kanagawa Cancer Center
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Kanagawa, Japani, 213-8587
- Rekrytointi
- Toranomon Branch Hospital
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Kashiwa-shi, Japani, 277-8577
- Rekrytointi
- National Cancer Center Hospital East
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Matsuyama, Japani, 791-0280
- Rekrytointi
- National Hospital Organization Shikoku Cancer Center
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Numakunai, Japani, 028-3695
- Rekrytointi
- Iwate Medical University Hospital
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Saitama, Japani, 362-0806
- Rekrytointi
- Saitama Cancer Center
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Sakaishi, Japani, 591-8555
- Rekrytointi
- NHO Kinki-Chuo Chest Medical Center
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Ontario
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Toronto, Ontario, Kanada, M5G 1Z5
- Rekrytointi
- Princess Margaret Cancer Center
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Beijing, Kiina, 100142
- Rekrytointi
- Beijing Cancer Hospital
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Changchun, Kiina, 130021
- Rekrytointi
- the First Hospital of Jilin University
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Chengdu, Kiina, 610041
- Rekrytointi
- West China Hospital of Sichuan University
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Guangzhou, Kiina, 510515
- Rekrytointi
- Nanfang Hospital, Southern Medical University
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Guangzhou, Kiina, 510000
- Rekrytointi
- Cancer Center of Guangzhou Medical University
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Hangzhou, Kiina, 310022
- Rekrytointi
- Zhejiang Cancer Hospital
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Hangzhou, Kiina, 310014
- Rekrytointi
- Zhejiang People's Hospital
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Hangzhou, Kiina, 310016
- Rekrytointi
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, Kiina, 150081
- Rekrytointi
- Harbin Medical University Cancer Hospital
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Hefei, Kiina, 230601
- Rekrytointi
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, Kiina, 514031
- Rekrytointi
- Meizhou People's Hospital
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Nanchang, Kiina, 330052
- Rekrytointi
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, Kiina, 210029
- Rekrytointi
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, Kiina, 200030
- Rekrytointi
- Shanghai Chest Hospital
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Shanghai, Kiina, 200120
- Rekrytointi
- Fudan University Shanghai Cancer Center
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Shanghai, Kiina, 201104
- Rekrytointi
- Shanghai Geriatric Medical Center
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Tianjin, Kiina, 300060
- Rekrytointi
- Tianjin Cancer Hospital
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Xi'an, Kiina, 710061
- Rekrytointi
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, Kiina, 710126
- Rekrytointi
- Xi'an International Medical Center Hospital
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Xiamen, Kiina, 361003
- Rekrytointi
- The First Affiliated Hospital of Xiamen University
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Xinxiang, Kiina
- Rekrytointi
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, Kiina, 450008
- Rekrytointi
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Kiina, 430048
- Rekrytointi
- 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, Kiina, 710061
- Rekrytointi
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kiina, 200032
- Rekrytointi
- Fudan University Shanghai Cancer Center
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Asvestochóri, Kreikka, 570 10
- Rekrytointi
- General Hospital "G.Papanikolaou"
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Cholargós, Kreikka, 155 62
- Rekrytointi
- Metropolitan General Hospital
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Durango, Meksiko, 34000
- Aktiivinen, ei rekrytointi
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, Meksiko
- Aktiivinen, ei rekrytointi
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, Meksiko, 97070
- Valmis
- Medical Care & Research
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Gda?sk, Puola, 80-214
- Rekrytointi
- Uniwersyteckie Centrum Kliniczne
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Koszalin, Puola, 75-581
- Rekrytointi
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, Puola, 02-781
- Rekrytointi
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Bordeaux, Ranska, 33076
- Rekrytointi
- Institut Bergonie
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Caen, Ranska, 14076
- Rekrytointi
- Centre Francois Baclesse
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Dijon, Ranska, 21000
- Rekrytointi
- Institut de Cancérologie de Bourgogne
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Lyon, Ranska, 69373
- Rekrytointi
- Centre Leon Berard
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Marseille, Ranska, 13005
- Rekrytointi
- Hopital de la Timone
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Montpellier, Ranska, 34298
- Rekrytointi
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, Ranska, 44093
- Rekrytointi
- CHU de Nantes - Hotel Dieu
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Nîmes, Ranska, 30029
- Valmis
- Institut de cancerologie du Gard
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Paris, Ranska, 75005
- Rekrytointi
- Institut Curie
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Paris, Ranska, 75970
- Rekrytointi
- Hopital Tenon
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Saint-Herblain, Ranska, 44805
- Rekrytointi
- ICO - Site René Gauducheau
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Toulouse, Ranska, 31059
- Rekrytointi
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, Ranska, 54511
- Rekrytointi
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, Ranska, 94800
- Rekrytointi
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Ranska, 13005
- Rekrytointi
- AP-HM- Hôpital de La Timone
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Taichung, Taiwan, 407
- Rekrytointi
- Taichung Veterans General Hospital
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Tainan, Taiwan, 70457
- Rekrytointi
- National Cheng Kung University Hospital
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Taipei, Taiwan, 110
- Rekrytointi
- National Taiwan University Hospital
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Taoyuan, Taiwan, 333
- Aktiivinen, ei rekrytointi
- Chang Gung Memorial Hospital - Linkou
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Bangkok, Thaimaa, 10700
- Rekrytointi
- Siriraj Hospital
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Bangkok, Thaimaa, 10330
- Aktiivinen, ei rekrytointi
- Chulalongkorn Hospital
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Chiang Mai, Thaimaa, 50200
- Aktiivinen, ei rekrytointi
- Maharaj Nakorn Chiangmai Hospital
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Kyiv, Ukraina, 02000
- Rekrytointi
- Arensia Exploratory Medicine - Ukraine
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Moscow Oblast
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Moscow, Moscow Oblast, Venäjä, 117997
- Aktiivinen, ei rekrytointi
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, Venäjä, 125248
- Rekrytointi
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, Venäjä, 121205
- Rekrytointi
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, Venäjä, 119991
- Rekrytointi
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Leicester, Yhdistynyt kuningaskunta, LE1 5WW
- Rekrytointi
- Leicester Royal Infirmary
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Surrey, Yhdistynyt kuningaskunta, SM2 5PT
- Valmis
- Royal Marsden Hospital - Surrey
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
|
|
Kokeellinen: 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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Niiden osallistujien määrä, joilla on jatkuva pääsy Rochen IMP-pohjaiseen hoitoon ja/tai vertailuaineisiin
Aikaikkuna: Jopa noin 10 vuotta
|
Jopa noin 10 vuotta
|
|
Niiden osallistujien määrä ja vakavuus, joilla on valittuja haittatapahtumia arvioitu National Cancer Instituten yleisten haitallisten tapahtumien terminologiakriteerien (NCI CTCAE), versio 5.0 mukaisesti
Aikaikkuna: Jopa noin 10 vuotta
|
Jopa noin 10 vuotta
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Clinical Trials, Hoffmann-La Roche
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Vasta -aineet, monoklonaalinen, humanisoitu
- Vasta -aineet, monoklonaalinen
- Vasta -aineet
- Immunoglobuliinit
- Immunoproteiinit
- Veriproteiinit
- Seerumin globuliinit
- Globuliinit
- Bevasitsumabi
- geiredestrantti
- ipaSertibi
- söpö
- Tiragolumabi
- entrektinibi
- navolisib
Muut tutkimustunnusnumerot
- BX44273
- 2022-003414-36 (EudraCT-numero)
- 2023 (Yhdysvaltain NIH-apuraha/sopimus)
- 2023-504263-16-00 (Ctis)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .