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Активно (без набиране) Фаза 3 NCT03768063

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Фаза 3 – широко изпитване преди одобрение
Заболявания: Cancer

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.
Кой може да участва
Inclusion Criteria: * Eligible for continuing atezolizumab-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 * Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. 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 atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator * Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential * For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs * For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm 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 patient's country for the patient-specific disease and is accessible to the patient * Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study * Permanent discontinuation of atezolizumab 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). Exception: Participants who permanently discontinued atezolizumab from parent studies that permit participants to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study. * Ongoing serious adverse event(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 * Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications * Concurrent participation in any therapeutic clinical trial (other than the parent study) * Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated referenced safety information (RSI)
Места на провеждане 24
Австралия (1)
St Vincent'S Hospital
Darlinghurst , New South Wales
Белгия (1)
UZ Leuven
Leuven , Flemish Brabant
Бразилия (1)
Hospital Araujo Jorge
Goiânia , Goiás
България (1)
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv
Chile (1)
Pontificia Universidad Catolica de Chile
Santiago
Чехия (1)
Masaryk?v onkologický ústav
Brno
Дания (1)
Rigshospitalet
København Ø
Франция (1)
CHU Angers
Angers , Pays de la Loire Region
Гърция (1)
Metropolitan Hospital
Piraeus , Attica
Guatemala (1)
Grupo Angeles
Guatemala City
Hong Kong (1)
Queen Mary Hospital
Hong Kong
Унгария (1)
Orszagos Onkologiai Intezet
Budapest
Италия (1)
Istituto Nazionale dei Tumori
Milan , Lombardy
Япония (1)
Nagoya University Hospital
Aichi
Mexico (1)
Phylasis Clinicas Research S de RL de CV
Toluca
Полша (1)
Uniwersytecki Szpital Kliniczny w Poznaniu
Pozna? , Greater Poland Voivodeship
Румъния (1)
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
Cluj-Napoca
Russia (1)
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk , Arhangelsk
Словакия (1)
University Hospital Bratislava
Bratislava
Южна Корея (1)
Seoul National University Hospital
Seoul
Испания (1)
Hospital Universitario Quiron Dexeus
Barcelona
Тайланд (1)
Faculty of Med. Siriraj Hosp.
Bangkok
Ukraine (1)
Communal Non profit Enterprise Regional Center of Oncology
Kharkiv , Kharkiv Governorate
САЩ (1)
University of Colorado Cancer Center
Aurora , Colorado
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.02.2019
Крайна дата
05.07.2028
Регистрационен номер
NCT03768063
Източник
anzctr
Запитване за медицински туризъм

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