A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

Официальное название

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

Обзор

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.

Вмешательства

• Препарат Ipatasertib
  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.
• Препарат Tiragolumab
  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.
• Препарат Atezolizumab
  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.
• Препарат Tiragolumab and Atezolizumab
  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.
• Препарат Bevacizumab
  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.
• Препарат Entrectinib
  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.
• Препарат Inavolisib
  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.
• Препарат Divarasib
  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.

Первичные конечные точки

• Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s) [Срок оценки: Up to approximately 10 years]
• Number and Severity of Participants With Selected Adverse Events Assessed as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 [Срок оценки: Up to approximately 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Concurrent participation in any therapeutic clinical trial (other than the parent study)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 19 центров

• First Affiliated Hospital of Medical College of Xi'an Jiaotong University — XI 'an City, Shaanxi Province
• Fudan University Shanghai Cancer Center — Шанхай
• Beijing Cancer Hospital — Пекин
• the First Hospital of Jilin University — Changchun
• West China Hospital of Sichuan University — Чэнду
• Cancer Center of Guangzhou Medical University — Гуанчжоу
• Sir Run Run Shaw Hospital Zhejiang University — Ханчжоу
• Zhejiang Cancer Hospital — Ханчжоу
• … и ещё 11 центров

Франция · 12 центров

• Institut Bergonie — Bordeaux
• Centre Francois Baclesse — Caen
• Institut de Cancérologie de Bourgogne — Dijon
• Centre Leon Berard — Lyon
• Hopital de la Timone — Marseille
• Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque — Montpellier
• Institut de cancerologie du Gard — Nîmes
• Institut Curie — Paris
• … и ещё 4 центра

Япония · 8 центров

• National Cancer Center Hospital East — Chiba
• Kyushu University Hospital — Fukuoka
• Toranomon Branch Hospital — Kanagawa
• Yokohama City University Medical Center — Kanagawa
• Kanagawa Cancer Center — Kanagawa
• National Cancer Center Hospital East — Kashiwa-shi
• Saitama Cancer Center — Saitama
• NHO Kinki-Chuo Chest Medical Center — Sakaishi

Тайвань · 4 центра

• Taichung Veterans General Hospital — Taichung
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Chang Gung Memorial Hospital - Linkou — Taoyuan

Бельгия · 3 центра

• GHdC Site Les Viviers — Charleroi
• AZ Groeninge — Kortrijk
• UZ Leuven Gasthuisberg — Leuven

Мексика · 3 центра

• Centro Medico Culiacan SA de CV — Culiacán
• Medical Care & Research — Mérida
• Consultorio de Especialidad en Urologia Privado — Durango

Россия · 3 центра

• Moscow City Oncology Hospital #62 — Moscovskaya Oblast
• Russian Scientific Center of Roentgenoradiology — Moscow
• P.A. Herzen Oncological Inst. — Moscow

South Korea · 3 центра

• Seoul National University Bundang Hospital — Seongnam-si
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul

Таиланд · 3 центра

• Chulalongkorn Hospital — Bangkok
• Siriraj Hospital — Bangkok
• Maharaj Nakorn Chiangmai Hospital — Chiang Mai

Costa Rica · 2 центра

• Clinica CIMCA — San José
• ICIMED Instituto de Investigación en Ciencias Médicas — San José

Греция · 2 центра

• General Hospital "G.Papanikolaou" — Asvestochóri
• Metropolitan General Hospital — Cholargós

Польша · 2 центра

• Uniwersyteckie Centrum Kliniczne — Gda?sk
• Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie — Warsaw

Великобритания · 2 центра

• Leicester Royal Infirmary — Leicester
• Royal Marsden Hospital - Surrey — Surrey

Канада · 1 центр

• Princess Margaret Cancer Center — Toronto

Идентификаторы

NCT: NCT05862285 · BX44273 · 2022-003414-36 · 2023-504263-16-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗