이전에 Genentech 및/또는 F. Hoffman-La Roche 후원 연구에 등록한 참가자를 위한 롤오버 연구 (UmbrellaMAX)
이전에 Genentech 및/또는 F. Hoffmann-La Roche Ltd 후원 연구에 등록한 환자를 대상으로 한 오픈 라벨, 다기관 확장 연구
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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
연구 연락처 백업
- 이름: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
- 전화번호: 888-662-6728 (U.S. Only)
- 이메일: global-roche-genentech-trials@gene.com
연구 장소
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Asvestochóri, 그리스, 570 10
- 모병
- General Hospital "G.Papanikolaou"
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Cholargós, 그리스, 155 62
- 모병
- Metropolitan General Hospital
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Taichung, 대만, 407
- 모병
- Taichung Veterans General Hospital
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Tainan, 대만, 70457
- 모병
- National Cheng Kung University Hospital
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Taipei, 대만, 110
- 모병
- National Taiwan University Hospital
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Taoyuan, 대만, 333
- 모집하지 않고 적극적으로
- Chang Gung Memorial Hospital - Linkou
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Goyang-si, 대한민국, 10408
- 모병
- National Cancer Center
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Gyeonggi-do, 대한민국, 13496
- 모병
- CHA Bundang Medical Center
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Seongnam-si, 대한민국, 463-707
- 완전한
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
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Seoul, 대한민국, 05505
- 모집하지 않고 적극적으로
- Asan Medical Center
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Moscow Oblast
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Moscow, Moscow Oblast, 러시아 제국, 117997
- 모집하지 않고 적극적으로
- Russian Scientific Center of Roentgenoradiology
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Moscow, Moscow Oblast, 러시아 제국, 125248
- 모병
- P.A. Herzen Oncological Inst.
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Moscow, Moscow Oblast, 러시아 제국, 121205
- 모병
- Moscow City Oncology Hospital #62
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Moskva, Moscow Oblast, 러시아 제국, 119991
- 모병
- I.M.Sechenov First Moscow State Medical University (1st MSMU)
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Durango, 멕시코, 34000
- 모집하지 않고 적극적으로
- Consultorio de Especialidad en Urologia Privado
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Sinaloa
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Culiacán, Sinaloa, 멕시코
- 모집하지 않고 적극적으로
- Centro Medico Culiacan SA de CV
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Yucatán
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Mérida, Yucatán, 멕시코, 97070
- 완전한
- Medical Care & Research
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Charleroi, 벨기에, 6060
- 완전한
- GHdC Site Les Viviers
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Kortrijk, 벨기에, 8500
- 모집하지 않고 적극적으로
- AZ Groeninge
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Leuven, 벨기에, 3000
- 모집하지 않고 적극적으로
- UZ Leuven Gasthuisberg
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Leuven, 벨기에, 3000
- 완전한
- UZ Leuven Gasthuisberg
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Leicester, 영국, LE1 5WW
- 모병
- Leicester Royal Infirmary
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Surrey, 영국, SM2 5PT
- 완전한
- Royal Marsden Hospital - Surrey
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Kyiv, 우크라이나, 02000
- 모병
- Arensia Exploratory Medicine - Ukraine
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Chiba, 일본, 277-8577
- 모병
- National Cancer Center Hospital East
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Chuo-ku, Fukuoka-shi, 일본, 810-8563
- 모병
- National Hospital Organization Kyushu Medical Center
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Fukuoka, 일본, 812-8582
- 모병
- Kyushu University Hospital
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Kanagawa, 일본, 232-0024
- 모집하지 않고 적극적으로
- Yokohama City University Medical Center
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Kanagawa, 일본, 241-8515
- 완전한
- Kanagawa Cancer Center
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Kanagawa, 일본, 213-8587
- 모병
- Toranomon Branch Hospital
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Kashiwa-shi, 일본, 277-8577
- 모병
- National Cancer Center Hospital East
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Matsuyama, 일본, 791-0280
- 모병
- National Hospital Organization Shikoku Cancer Center
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Numakunai, 일본, 028-3695
- 모병
- Iwate Medical University Hospital
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Saitama, 일본, 362-0806
- 모병
- Saitama Cancer Center
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Sakaishi, 일본, 591-8555
- 모병
- NHO Kinki-Chuo Chest Medical Center
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Beijing, 중국, 100142
- 모병
- Beijing Cancer Hospital
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Changchun, 중국, 130021
- 모병
- the First Hospital of Jilin University
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Chengdu, 중국, 610041
- 모병
- West China Hospital of Sichuan University
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Guangzhou, 중국, 510515
- 모병
- Nanfang Hospital, Southern Medical University
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Guangzhou, 중국, 510000
- 모병
- Cancer Center of Guangzhou Medical University
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Hangzhou, 중국, 310022
- 모병
- Zhejiang Cancer Hospital
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Hangzhou, 중국, 310014
- 모병
- Zhejiang People's Hospital
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Hangzhou, 중국, 310016
- 모병
- Sir Run Run Shaw Hospital Zhejiang University
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Harbin, 중국, 150081
- 모병
- Harbin Medical University Cancer Hospital
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Hefei, 중국, 230601
- 모병
- The Second Affiliated Hospital of Anhui Medical University
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Meizhou, 중국, 514031
- 모병
- Meizhou People's Hospital
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Nanchang, 중국, 330052
- 모병
- The 1st Affiliated Hospital of Nanchang Unversity
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Nanjing, 중국, 210029
- 모병
- Jiangsu Province Hospital of Chinese Medicine
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Shanghai, 중국, 200030
- 모병
- Shanghai Chest Hospital
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Shanghai, 중국, 200120
- 모병
- Fudan University Shanghai Cancer Center
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Shanghai, 중국, 201104
- 모병
- Shanghai Geriatric Medical Center
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Tianjin, 중국, 300060
- 모병
- Tianjin Cancer Hospital
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Xi'an, 중국, 710061
- 모병
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'an, 중국, 710126
- 모병
- Xi'an International Medical Center Hospital
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Xiamen, 중국, 361003
- 모병
- The First Affiliated Hospital of Xiamen University
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Xinxiang, 중국
- 모병
- The First Affiliated Hospital of Xinxiang Medical University
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Zhengzhou, 중국, 450008
- 모병
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, 중국, 430048
- 모병
- 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, 중국, 710061
- 모병
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200032
- 모병
- Fudan University Shanghai Cancer Center
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Ontario
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Toronto, Ontario, 캐나다, M5G 1Z5
- 모병
- Princess Margaret Cancer Center
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San José, 코스타리카, 10103
- 모집하지 않고 적극적으로
- Clinica CIMCA
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San José, 코스타리카, 10108
- 모집하지 않고 적극적으로
- ICIMED Instituto de Investigación en Ciencias Médicas
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Bangkok, 태국, 10700
- 모병
- Siriraj Hospital
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Bangkok, 태국, 10330
- 모집하지 않고 적극적으로
- Chulalongkorn Hospital
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Chiang Mai, 태국, 50200
- 모집하지 않고 적극적으로
- Maharaj Nakorn Chiangmai Hospital
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Gda?sk, 폴란드, 80-214
- 모병
- Uniwersyteckie Centrum Kliniczne
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Koszalin, 폴란드, 75-581
- 모병
- Szpital Wojewódzki im. Miko?aja Kopernika
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Warsaw, 폴란드, 02-781
- 모병
- Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
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Bordeaux, 프랑스, 33076
- 모병
- Institut Bergonie
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Caen, 프랑스, 14076
- 모병
- Centre Francois Baclesse
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Dijon, 프랑스, 21000
- 모병
- Institut de Cancérologie de Bourgogne
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Lyon, 프랑스, 69373
- 모병
- Centre Leon Berard
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Marseille, 프랑스, 13005
- 모병
- Hopital de la Timone
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Montpellier, 프랑스, 34298
- 모병
- Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
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Nantes, 프랑스, 44093
- 모병
- CHU de Nantes - Hotel Dieu
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Nîmes, 프랑스, 30029
- 완전한
- Institut de cancerologie du Gard
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Paris, 프랑스, 75005
- 모병
- Institut Curie
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Paris, 프랑스, 75970
- 모병
- Hopital Tenon
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Saint-Herblain, 프랑스, 44805
- 모병
- ICO - Site René Gauducheau
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Toulouse, 프랑스, 31059
- 모병
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, 프랑스, 54511
- 모병
- Hopitaux de Brabois - Gastro-Entereologie
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Villejuif, 프랑스, 94800
- 모병
- Gustave Roussy
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, 프랑스, 13005
- 모병
- AP-HM- Hôpital de La Timone
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Roche IMP(들) 기반 요법 및/또는 비교 약제에 지속적으로 접근할 수 있는 참가자 수
기간: 최장 약 10년
|
최장 약 10년
|
|
국립암연구소(NCI CTCAE) 부작용에 대한 공통 용어 기준, 버전 5.0에 따라 평가된 선택된 부작용이 있는 참가자의 수 및 심각도
기간: 최대 약 10년
|
최대 약 10년
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Clinical Trials, Hoffmann-La Roche
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BX44273
- 2022-003414-36 (EudraCT 번호)
- 2023 (미국 NIH 보조금/계약)
- 2023-504263-16-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .