Tazemetostat for Sarcoma

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Epizyme, Inc.

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This study will include participants with various types of cancer known as soft-tissue sarcomas. Tissues that can be affected by soft tissue sarcomas include fat, muscle, blood vessels, deep skin tissues, tendons and ligaments. Soft tissue cancers are rare and can occur almost anywhere in the body. Part 1 of this trial will study the safety and the level that adverse effects of the study drug tazemetostat in combination with doxorubicin (current front line treatment) 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 how long participants live without their disease getting worse when receiving the study drug plus doxorubicin versus doxorubicin plus placebo (dummy treatment).

Eligibility Criteria

Adults over 18 with various advanced soft-tissue sarcomas, for which no standard treatments are available. Participants must have a life expectancy of more than 3 months and adequate organ function. They should not have had prior exposure to tazemetostat or similar drugs, major surgery within the last 3 weeks, or certain cardiovascular conditions.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

Has provided signed written informed consent

Your biopsy results have been confirmed by a certified laboratory.

+15 more

Exclusion Criteria

I have previously been treated with tazemetostat or similar medications.

I have not taken part in a drug trial within the last 30 days or 5 half-lives of the drug.

I have not had major surgery in the last 3 weeks.

+17 more

Participant Groups

The trial is testing Tazemetostat in combination with doxorubicin against doxorubicin plus placebo. Part 1 determines the safe dosage and side effects (tolerability) of Tazemetostat; Part 2 compares how long patients live without disease progression using these combinations.

1Treatment groups

Experimental Treatment

Group I: Open-label TazemetostatExperimental Treatment1 Intervention

All cohorts will receive 800 mg oral Tazemetostat twice a day in continuous 28-day cycles.

Tazemetostat is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tazverik for: