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Набира участници Фаза 3 NCT06174987

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Advanced Cancer Metastatic Cancer

Спонсор: Daiichi Sankyo

Налично на: БГ
Обобщение
This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).
Описание
This Master Rollover Study includes sub-protocols with different study drugs. This Master Rollover Protocol describes core study elements that are applicable to all study drugs that will be provided under the Rollover Study.
Кой може да участва
Inclusion Criteria: * Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements. * Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition. * No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s). Exclusion Criteria: * Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria * Participant who has been off T-DXd therapy for \>18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study
Места на провеждане 12
Австралия (1)
Flinders Medical Center
Bedford Park
ACTIVE_NOT_RECRUITING
Белгия (1)
Grand Hôpital de Charleroi
Charleroi
Бразилия (1)
Instituto Aericas
Rio de Janeiro
NOT_YET_RECRUITING
Франция (1)
Institut Gustave Roussy
Villejuif
Израел (1)
Rabin Medical Center
Petah Tikva
ACTIVE_NOT_RECRUITING
Италия (1)
Ospedale San Raffaele
Milan
Япония (1)
National Cancer Center Hospital
Chūō
Южна Корея (1)
Kyungpook National University Chilgok Hospital
Daegu
Испания (1)
Complejo Hospitalario Universitario A Coruña
A Coruña
Taiwan (1)
National Cheng Kung University Hospital
Tainan
WITHDRAWN
Великобритания (1)
Royal Surrey County Hospital
Guildford
WITHDRAWN
САЩ (1)
Miami Cancer Institute
Miami , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
05.01.2024
Крайна дата
17.01.2028
Регистрационен номер
NCT06174987
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.