En rollover-studie för deltagare som tidigare varit inskrivna i en Genentech- och/eller F. Hoffman-La Roche-sponsrad studie (UmbrellaMAX)
En öppen etikett, multicenterutvidgningsstudie på patienter som tidigare varit inskrivna i en Genentech och/eller F. Hoffmann-La Roche Ltd sponsrad 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studera Kontakt Backup
- Namn: 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
Studieorter
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Charleroi, Belgien, 6060
- Avslutad
- GHdC Site Les Viviers
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Kortrijk, Belgien, 8500
- Aktiv, inte rekryterande
- AZ Groeninge
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Leuven, Belgien, 3000
- Aktiv, inte rekryterande
- UZ Leuven Gasthuisberg
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Leuven, Belgien, 3000
- Avslutad
- UZ Leuven Gasthuisberg
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San José, Costa Rica, 10103
- Aktiv, inte rekryterande
- Clinica CIMCA
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San José, Costa Rica, 10108
- Aktiv, inte rekryterande
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bordeaux, Frankrike, 33076
- Rekrytering
- Institut Bergonie
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Caen, Frankrike, 14076
- Rekrytering
- Centre Francois Baclesse
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Dijon, Frankrike, 21000
- Rekrytering
- Institut de Cancérologie de Bourgogne
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Lyon, Frankrike, 69373
- Rekrytering
- Centre Leon Berard
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Marseille, Frankrike, 13005
- Rekrytering
- Hopital de la Timone
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Montpellier, Frankrike, 34298
- Rekrytering
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, Frankrike, 44093
- Rekrytering
- CHU de Nantes - Hotel Dieu
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Nîmes, Frankrike, 30029
- Avslutad
- Institut de cancerologie du Gard
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Paris, Frankrike, 75005
- Rekrytering
- Institut Curie
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Paris, Frankrike, 75970
- Rekrytering
- Hopital Tenon
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Saint-Herblain, Frankrike, 44805
- Rekrytering
- ICO - Site René Gauducheau
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Toulouse, Frankrike, 31059
- Rekrytering
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, Frankrike, 54511
- Rekrytering
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, Frankrike, 94800
- Rekrytering
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankrike, 13005
- Rekrytering
- AP-HM- Hôpital de La Timone
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Asvestochóri, Grekland, 570 10
- Rekrytering
- General Hospital "G.Papanikolaou"
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Cholargós, Grekland, 155 62
- Rekrytering
- Metropolitan General Hospital
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Chiba, Japan, 277-8577
- Rekrytering
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, Japan, 810-8563
- Rekrytering
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japan, 812-8582
- Rekrytering
- Kyushu University Hospital
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Kanagawa, Japan, 232-0024
- Aktiv, inte rekryterande
- Yokohama City University Medical Center
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Kanagawa, Japan, 241-8515
- Avslutad
- Kanagawa Cancer Center
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Kanagawa, Japan, 213-8587
- Rekrytering
- Toranomon Branch Hospital
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Kashiwa-shi, Japan, 277-8577
- Rekrytering
- National Cancer Center Hospital East
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Matsuyama, Japan, 791-0280
- Rekrytering
- National Hospital Organization Shikoku Cancer Center
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Numakunai, Japan, 028-3695
- Rekrytering
- Iwate Medical University Hospital
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Saitama, Japan, 362-0806
- Rekrytering
- Saitama Cancer Center
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Sakaishi, Japan, 591-8555
- Rekrytering
- NHO Kinki-Chuo Chest Medical Center
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Ontario
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Toronto, Ontario, Kanada, M5G 1Z5
- Rekrytering
- Princess Margaret Cancer Center
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Beijing, Kina, 100142
- Rekrytering
- Beijing Cancer Hospital
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Changchun, Kina, 130021
- Rekrytering
- the First Hospital of Jilin University
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Chengdu, Kina, 610041
- Rekrytering
- West China Hospital of Sichuan University
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Guangzhou, Kina, 510515
- Rekrytering
- Nanfang Hospital, Southern Medical University
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Guangzhou, Kina, 510000
- Rekrytering
- Cancer Center of Guangzhou Medical University
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Hangzhou, Kina, 310022
- Rekrytering
- Zhejiang Cancer Hospital
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Hangzhou, Kina, 310014
- Rekrytering
- Zhejiang People's Hospital
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Hangzhou, Kina, 310016
- Rekrytering
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, Kina, 150081
- Rekrytering
- Harbin Medical University Cancer Hospital
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Hefei, Kina, 230601
- Rekrytering
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, Kina, 514031
- Rekrytering
- Meizhou People's Hospital
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Nanchang, Kina, 330052
- Rekrytering
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, Kina, 210029
- Rekrytering
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, Kina, 200030
- Rekrytering
- Shanghai Chest Hospital
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Shanghai, Kina, 200120
- Rekrytering
- Fudan University Shanghai Cancer Center
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Shanghai, Kina, 201104
- Rekrytering
- Shanghai Geriatric Medical Center
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Tianjin, Kina, 300060
- Rekrytering
- Tianjin Cancer Hospital
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Xi'an, Kina, 710061
- Rekrytering
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, Kina, 710126
- Rekrytering
- Xi'an International Medical Center Hospital
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Xiamen, Kina, 361003
- Rekrytering
- The First Affiliated Hospital of Xiamen University
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Xinxiang, Kina
- Rekrytering
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, Kina, 450008
- Rekrytering
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Kina, 430048
- Rekrytering
- 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
- Rekrytering
- 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
- Rekrytering
- Fudan University Shanghai Cancer Center
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Durango, Mexiko, 34000
- Aktiv, inte rekryterande
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, Mexiko
- Aktiv, inte rekryterande
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, Mexiko, 97070
- Avslutad
- Medical Care & Research
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Gda?sk, Polen, 80-214
- Rekrytering
- Uniwersyteckie Centrum Kliniczne
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Koszalin, Polen, 75-581
- Rekrytering
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, Polen, 02-781
- Rekrytering
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Moscow Oblast
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Moscow, Moscow Oblast, Ryssland, 117997
- Aktiv, inte rekryterande
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, Ryssland, 125248
- Rekrytering
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, Ryssland, 121205
- Rekrytering
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, Ryssland, 119991
- Rekrytering
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Leicester, Storbritannien, LE1 5WW
- Rekrytering
- Leicester Royal Infirmary
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Surrey, Storbritannien, SM2 5PT
- Avslutad
- Royal Marsden Hospital - Surrey
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Goyang-si, Sydkorea, 10408
- Rekrytering
- National Cancer Center
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Gyeonggi-do, Sydkorea, 13496
- Rekrytering
- CHA Bundang Medical Center
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Seongnam-si, Sydkorea, 463-707
- Avslutad
- Seoul National University Bundang Hospital
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Seoul, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center
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Seoul, Sydkorea, 05505
- Aktiv, inte rekryterande
- Asan Medical Center
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Taichung, Taiwan, 407
- Rekrytering
- Taichung Veterans General Hospital
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Tainan, Taiwan, 70457
- Rekrytering
- National Cheng Kung University Hospital
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Taipei, Taiwan, 110
- Rekrytering
- National Taiwan University Hospital
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Taoyuan, Taiwan, 333
- Aktiv, inte rekryterande
- Chang Gung Memorial Hospital - Linkou
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Bangkok, Thailand, 10700
- Rekrytering
- Siriraj Hospital
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Bangkok, Thailand, 10330
- Aktiv, inte rekryterande
- Chulalongkorn Hospital
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Chiang Mai, Thailand, 50200
- Aktiv, inte rekryterande
- Maharaj Nakorn Chiangmai Hospital
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Kyiv, Ukraina, 02000
- Rekrytering
- Arensia Exploratory Medicine - Ukraine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Antal deltagare med fortsatt tillgång till Roche IMP(s)-baserad terapi och/eller jämförelsemedel(er)
Tidsram: Upp till cirka 10 år
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Upp till cirka 10 år
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Antal och svårighetsgrad av deltagare med utvalda biverkningar bedömda enligt National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Tidsram: Upp till cirka 10 år
|
Upp till cirka 10 år
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Clinical Trials, Hoffmann-La Roche
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BX44273
- 2022-003414-36 (EudraCT-nummer)
- 2023 (U.S.S. NIH-anslag/kontrakt)
- 2023-504263-16-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
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