Spots Global Cancer Trial Database for A Study to Assess the Long-term Safety of Tazemetostat
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Trial Identification
Brief Title: A Study to Assess the Long-term Safety of Tazemetostat
Official Title: Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study
Study ID: NCT02875548
Interventions
Study Description
Brief Summary: This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy. The aim of the study will be to assess the long-term safety of tezemetostat.
Detailed Description: This open-label, multicenter, global study will provide continuing access to tazemetostat therapy for subjects who have completed their participation in a prior tazemetostat study (either with monotherapy or combination therapy) without unacceptable toxicity, have not had evidence of tumor progression as defined by disease-appropriate standard criteria, and continue to receive clinical benefit from the therapy. Subjects will receive tazemetostat as dictated in their antecedent study. Visits will be conducted per Standard of Care (SoC) as appropriate in each country and as determined by the Investigator. Subjects will be followed for long-term safety in addition to time to treatment failure (TTF) and overall survival (OS).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Arizona, United States
Moffitt, Tampa, Florida, United States
University of Michigan, Ann Arbor, Michigan, United States
Columbia University Medical Center, New York, New York, United States
Monash Medical Centre- Monash Campus, Clayton, , Australia
Geelong Hospital, Geelong, , Australia
Peter MacCallum Cancer Institute, Melbourne, , Australia
University Hospital (UZ) Leuven, Leuven, , Belgium
Institut Bergonie, Bordeaux Cedex, , France
CHU de Caen - Hôpital Côte de Nacre, Caen, , France
CHRU de Lile- Hopital Claude Huriez, Lille Cedex, , France
Hôpital Saint Louis - AP-HP, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
CHU Rennes- Hopital Pontchaillou, Rennes Cedex, , France
Centre Henri Becquerel, Rouen, , France
Gustave Roussay, Villejuif, , France
Pratia MCM Krakow, Kraków, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej, Warszawa, , Poland
S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine", Kharkiv, , Ukraine
Beatson, West of Scotland Cancer Centre, Glasgow, , United Kingdom
Oncology and Haematology Clinical Trials Unit, Leicester, , United Kingdom
Clatterbridge Cancer Centre, Liverpool, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Ipsen Medical Director
Affiliation: Ipsen
Role: STUDY_DIRECTOR
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