Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma

Stopped early · Phase 1

Conditions studied: Advanced Soft-tissue Sarcoma, Advanced Epithelioid Sarcoma

In brief

The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue. Part 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study. Part 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse. The study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma

Key facts

Study ID

NCT04204941

Run by

Epizyme, Inc.

People needed

25

Starts

2019-12-19

Expected to finish

2024-06-14

Last updated by the study team

2026-01-07

Who can join

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

You may qualify if…

• Participants must meet ALL the following inclusion criteria to be eligible to enroll in this study:
• 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.
• Life expectancy ≥ 3 months before enrollment
• Phase 1b: 18-65 years old histologically confirmed Soft Tissue Sarcoma
• Phase 3: ≥18 years old with unresectable locally advanced or metastatic Epithelioid Sarcoma and tumor tissue available
• Have measurable disease
• Eastern Cooperative Oncology Group Performance Status (ECOG) performance status of 0, 1, or 2
• Have adequate hematologic (bone marrow (BM) and coagulation factors), renal and hepatic function as required per protocol
• Females must not be lactating or pregnant at Screening or Baseline
• 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
• Male participants of child-bearing potential must have had either a successful vasectomy or practice highly effective contraception
• Participants diagnosed with human immunodeficiency virus (HIV) are eligible to participate in the study if their infection is well controlled on anti-retroviral therapy.

You may not qualify if…

• Participants meeting any of the following exclusion criteria are NOT eligible to enroll in this study:
• Prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2 (EZH2).
• Prior systemic anticancer therapy.
• Contraindications noted in the doxorubicin label
• Have any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
• Have prior history of T-cell lymphoblastic lymphoma (T- LBL/)/T-cell acute lymphoblastic leukemia (T-ALL).
• 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.
• Have known active central nervous system (CNS) or any leptomeningeal metastasis of primary extracranial tumor.
• Participants taking medications that are known potent cytochrome P450 3A4 (CYP3A4) inducers/inhibitors (including St. John's Wort)
• 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.
• Major surgery within 4 weeks before the first dose of study treatment. Participants must have recovered from surgery prior to enrollment to this study.
• 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.
• Have an active infection requiring systemic therapy.
• Are immunocompromised (ie, has a congenital immunodeficiency).
• Have known hypersensitivity to any component of tazemetostat or doxorubicin.
• Cardiovascular impairment as stated in the protocol
• 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).
• 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.
• Female participants who are pregnant or breastfeeding.
• Participants who have undergone a solid organ transplant.
• Participants with malignancies other than STS (phase 1b) or ES (Phase 3 only).
• Participants housed in an institution by order of the authorities or courts.

Where it is running

• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Sarcoma Oncology Research Center — Santa Monica, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Insititute — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Sarah Cannon and HCA Research Institute — Nashville, Tennessee, United States
• Fred Hutchinson Research Center — Seattle, Washington, United States
• McGill University Faculty of Medicine - Royal Victoria Hospital — Montreal, Quebec, Canada
• National Taiwan University Hospital — Taipei, Taiwan
• Royal Marsden Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.