A Study to Assess the Long-term Safety of Tazemetostat
- Registration Number
- NCT02875548
- Lead Sponsor
- Epizyme, Inc.
- 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)
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Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- Subjects must meet ALL criteria to be eligible for enrollment in this study.
- Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat.
- Is currently receiving tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or any other clinical trial being conducted with tazemetostat that is not sponsored by Epizyme (including but not limited to, investigator-initiated trials). For subjects on combination therapy, treatment with other therapeutic(s) must have been completed in the antecedent study or will be provided by a source other than Epizyme if combination therapeutics are continued in this study until disease progression, treatment toxicity, subject preference or death, up to approximately 7 years.
- Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
- Has a life expectancy of ≥3 months.
- Has adequate hematologic, (bone marrow [BM] and coagulation factors), renal, and hepatic function. Subject must remain eligible for continued treatment with tazemetostat according to the eligibility and treatment criteria from the antecedent study
Subjects meeting ANY of the following criteria must NOT be enrolled in this study:
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Has had an interruption of tazemetostat dosing of >14 days from the antecedent clinical study to starting the rollover study unless approved by the Medical Monitor.
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Has another malignancy other than the one for which they are receiving tazemetostat.
• Exception: Subject who has been disease-free of a prior malignancy for 5 years or subject with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma is eligible.
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Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
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Has a prior history of T-LBL/T-ALL.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-label Tazemetostat Tazemetostat Participants will continue to receive the same tazemetostat dose and schedule as specified in their antecedent tazemetostat protocol. For participants on combination therapy, the other therapeutic(s) must have been completed in the antecedent study or be provided by a source other than Epizyme if combination treatment is continued in this clinical rollover study.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs) Until end of study an average of 7 years An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention Severity of adverse events experienced by all participants will be evaluated by the Investigator based on the CTCAE, version 5.0.
Duration of Study Drug Exposure Until end of study an average of 7 years The average study drug exposure duration will be reported.
- Secondary Outcome Measures
Name Time Method The overall survival (OS) Until end of study an average of 7 years Defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause
Trial Locations
- Locations (29)
California Cancer Associates For Research And Excellence, cCARE
🇺🇸Santa Fe, California, United States
Central Care Cancer Center
🇺🇸Bolivar, Missouri, United States
Astera Cancer Center
🇺🇸East Brunswick, New Jersey, United States
CHU de Montpellier - Hopital Saint Eloi
🇫🇷Montpellier, France
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
David H. Koch Center for Cancer Care at memorial Sloan Kettering Cancer 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
Hammersmith Hospital
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
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