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Cancer drug tazemetostat gets Long-Term safety check in rollover trial

NCT ID NCT02875548

Disease control Sponsor: Epizyme, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study offers continued access to tazemetostat for 58 people with various cancers who already benefited from the drug in earlier trials. The main goal is to monitor long-term safety and side effects. Participants must have shown clinical benefit from tazemetostat before joining.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tazemetostat (a targeted cancer drug)
What this could lead to
If successful, this study could confirm that long-term use of tazemetostat is safe for people with certain cancers, supporting its continued use as a treatment option.
What could go wrong
This is a rollover study, not a new treatment test, so it won't prove whether tazemetostat works better than other options. Long-term side effects are still being monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

58 people

The number who actually took part.

Started

Aug 2016

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects must meet ALL criteria to be eligible for enrollment in this study. 2. Has demonstrated and continues to demonstrate clinical benefit from treatment with tazemetostat. 3. 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. 4. Has voluntarily provided signed written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. 5. Has a life expectancy of ≥3 months. 6. 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 Exclusion Criteria: Subjects meeting ANY of the following criteria must NOT be enrolled in this study: 1. 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. 2. 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. 3. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS). 4. Has a prior history of T-LBL/T-ALL.

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Conditions

The condition(s) this trial relates to.

collecting duct carcinoma diffuse large B-cell lymphoma epithelioid sarcoma follicular lymphoma mesothelioma neoplasm non-Hodgkin lymphoma synovial sarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors Diffuse large B cell lymphoma (DLBCL) Epitheliod sarcoma (ES) Follicular lymphoma (FL) Mesothelioma Non Hodgkin lymphoma (NHL) Renal medullary carcinoma Synovial sarcoma

Contacts and locations

Locations

  • Astera Cancer Center

    East Brunswick, New Jersey, 08816, United States

  • Beatson, West of Scotland Cancer Centre

    Glasgow, United Kingdom

  • CHRU de Lile- Hopital Claude Huriez

    Lille, 59037, France

  • CHU Rennes- Hopital Pontchaillou

    Rennes, 35033, France

  • CHU de Caen - Hôpital Côte de Nacre

    Caen, 14033, France

  • CHU de Montpellier - Hopital Saint Eloi

    Montpellier, France

  • California Cancer Associates For Research And Excellence, cCARE

    Santa Fe, California, 92024, United States

  • Central Care Cancer Center

    Bolivar, Missouri, 65613, United States

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • Clatterbridge Cancer Centre

    Liverpool, L7 8XP, United Kingdom

  • Columbia University Medical Center

    New York, New York, 10019, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • David H. Koch Center for Cancer Care at memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Geelong Hospital

    Geelong, Australia

  • Gustave Roussay

    Villejuif, 94805, France

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Hematology Oncology Associates of the Treasure Coast - Port St. Lucie

    Port Saint Lucie, Florida, 34952, United States

  • Hôpital Saint Louis - AP-HP

    Paris, 75010, France

  • Institut Bergonie

    Bordeaux, 33076, France

  • Moffitt

    Tampa, Florida, 33612, United States

  • Monash Health

    Monash, Australia

  • Monash Medical Centre- Monash Campus

    Clayton, 3168, Australia

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Endokrynologii Onkologicznej i Medycyny Nuklearnej

    Warsaw, Poland

  • Oncology and Haematology Clinical Trials Unit

    Leicester, LEI 5WW, United Kingdom

  • Peter MacCallum Cancer Institute

    Melbourne, 3002, Australia

  • Pratia MCM Krakow

    Krakow, 30-510, Poland

  • Princess Alexandra Hospital

    Alexandra, Australia

  • S.P. Grigoreva Institute of Medical Radiology and Oncology of NAMS of Ukraine"

    Kharkiv, 61024, Ukraine

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • University Hospital (UZ) Leuven

    Leuven, 3000, Belgium

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.