A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Disease Treated With Tazemetostat in a Previous Clinical Study

Completed · Phase 1/Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Synovial Sarcoma, Epitheliod Sarcoma (ES), Mesothelioma, Advanced Solid Tumors, Renal Medullary Carcinoma, Non-Hodgkin Lymphoma (NHL)

In brief

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.

Key facts

Study ID

NCT02875548

Run by

Epizyme, Inc.

People needed

58

Starts

2016-08-30

Expected to finish

2025-09-26

Last updated by the study team

2025-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subjects meeting ANY of the following criteria must NOT be enrolled in this study:
• 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.
• 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.
• Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
• Has a prior history of T-LBL/T-ALL.

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• California Cancer Associates For Research And Excellence, cCARE — Santa Fe, California, United States
• Hematology Oncology Associates of the Treasure Coast - Port St. Lucie — Port Saint Lucie, Florida, United States
• Moffitt — Tampa, Florida, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Central Care Cancer Center — Bolivar, Missouri, United States
• Astera Cancer Center — East Brunswick, New Jersey, 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
• University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Princess Alexandra Hospital — Alexandra, Australia
• Monash Medical Centre- Monash Campus — Clayton, Australia
• Geelong Hospital — Geelong, Australia
• Peter MacCallum Cancer Institute — Melbourne, Australia
• Monash Health — Monash, Australia
• University Hospital (UZ) Leuven — Leuven, Belgium
• Institut Bergonie — Bordeaux, France
• CHU de Caen - Hôpital Côte de Nacre — Caen, France
• CHRU de Lile- Hopital Claude Huriez — Lille, France
• CHU de Montpellier - Hopital Saint Eloi — Montpellier, France
• Hôpital Saint Louis - AP-HP — Paris, France
• Centre Hospitalier Lyon Sud — Pierre-Bénite, France
• CHU Rennes- Hopital Pontchaillou — Rennes, France
• Centre Henri Becquerel — Rouen, France

Full record on ClinicalTrials.gov

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