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Experimental combo for rare sarcoma shows early promise but trial halted

NCT ID NCT04204941

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new drug called tazemetostat combined with standard chemotherapy (doxorubicin) in people with advanced epithelioid sarcoma, a rare soft-tissue cancer. The trial aimed to find a safe dose and see if the combination could help patients live longer without their cancer worsening. However, the study was stopped early after enrolling only 25 participants, so we have very limited information on how well it works.

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) combined with doxorubicin (chemotherapy)
What this could lead to
If successful, this combination could offer a new frontline treatment option for advanced epithelioid sarcoma, potentially slowing disease progression.
What could go wrong
The trial was terminated early with only 25 participants, so results are very limited. It is too early to know if the combination is effective or safe for broader use.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Dec 2019

Finished

Jun 2024

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 Participants must meet ALL the following inclusion criteria to be eligible to enroll in this study: 1. Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol. Study related activities will not start until written consent is obtained. 2. Life expectancy ≥ 3 months before enrollment 3. Phase 1b: 18-65 years old histologically confirmed Soft Tissue Sarcoma 4. Phase 3: ≥18 years old with unresectable locally advanced or metastatic Epithelioid Sarcoma and tumor tissue available 5. Have measurable disease 6. Eastern Cooperative Oncology Group Performance Status (ECOG) performance status of 0, 1, or 2 7. Have adequate hematologic (bone marrow (BM) and coagulation factors), renal and hepatic function as required per protocol 8. Females must not be lactating or pregnant at Screening or Baseline 9. Females must not be pregnant or breast feeding and agree to use highly effective contraception during the clinical trial and for 6 months following the final dose of study 10. Male participants of child-bearing potential must have had either a successful vasectomy or practice highly effective contraception 11. Participants diagnosed with human immunodeficiency virus (HIV) are eligible to participate in the study if their infection is well controlled on anti-retroviral therapy. Exclusion Criteria Participants meeting any of the following exclusion criteria are NOT eligible to enroll in this study: 1. Prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2 (EZH2). 2. Prior systemic anticancer therapy. 3. Contraindications noted in the doxorubicin label 4. Have any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 5. Have prior history of T-cell lymphoblastic lymphoma (T- LBL/)/T-cell acute lymphoblastic leukemia (T-ALL). 6. Have participated in another interventional clinical study and received investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the planned first dose of study treatment. 7. Have known active central nervous system (CNS) or any leptomeningeal metastasis of primary extracranial tumor. 8. Participants taking medications that are known potent cytochrome P450 3A4 (CYP3A4) inducers/inhibitors (including St. John's Wort) 9. Are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from the diet and all foods that contain those fruits from time of enrollment to through the duration of study participation. 10. Major surgery within 4 weeks before the first dose of study treatment. Participants must have recovered from surgery prior to enrollment to this study. 11. Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of study treatment. 12. Have an active infection requiring systemic therapy. 13. Are immunocompromised (ie, has a congenital immunodeficiency). 14. Have known hypersensitivity to any component of tazemetostat or doxorubicin. 15. Cardiovascular impairment as stated in the protocol 16. Have a known active infection with hepatitis B virus (HBV, as measured by positive hepatitis B surface antigen), hepatitis C virus (HCV, as measured by positive hepatitis C antibody). 17. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the participant's participation in this study OR interfere with their ability to receive study treatment or complete the study. 18. Female participants who are pregnant or breastfeeding. 19. Participants who have undergone a solid organ transplant. 20. Participants with malignancies other than STS (phase 1b) or ES (Phase 3 only). 21. Participants housed in an institution by order of the authorities or courts.

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Conditions

The condition(s) this trial relates to.

epithelioid sarcoma soft tissue sarcoma

As listed by the trial registrant

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

Advanced epithelioid sarcoma Advanced soft-tissue sarcoma

Contacts and locations

Locations

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Insititute

    Boston, Massachusetts, 02215, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Fred Hutchinson Research Center

    Seattle, Washington, 98109, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214, United States

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224, United States

  • McGill University Faculty of Medicine - Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1, Canada

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Royal Marsden Foundation Trust

    London, SW3 6JJ, United Kingdom

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218, United States

  • Sarah Cannon and HCA Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarcoma Oncology Research Center

    Santa Monica, California, 90403, United States

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

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