# Tazemetostat with doxorubicin as front-line therapy for advanced epithelioid sarcoma (EZH-301 run-in)

Source: https://onco.cc/trials/tazemetostat-doxorubicin-es/  
OnCo record `tazemetostat-doxorubicin-es` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The attempt to move the EZH2 inhibitor tazemetostat into first-line epithelioid sarcoma alongside doxorubicin; the safety run-in enrolled 25 patients and the study was stopped, leaving the accelerated approval without its confirmatory trial.

## Summary

After tazemetostat's single-arm approval in 2020, Epizyme opened this study to test the drug with doxorubicin as front-line treatment for advanced epithelioid sarcoma, with a phase 1b run-in leading into a randomised phase 3. ClinicalTrials.gov records 25 participants and a terminated status; the sponsor's business changes after its acquisition by Ipsen preceded the closure. Its fate matters because the epithelioid sarcoma approval rested on a 62-patient cohort with a 15 percent response rate.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-16
- Tags: owner-request
- Registry id: NCT04204941
- Phase: 1
- Setting: Previously untreated advanced epithelioid sarcoma with loss of INI1/SMARCB1: tazemetostat added to doxorubicin, the safety run-in of the planned randomised confirmatory trial; started December 2019, 25 enrolled, terminated by the sponsor
- Sponsor: Epizyme (Ipsen)
- Enrolled: 25

## Sources

- ClinicalTrials.gov NCT04204941: https://clinicaltrials.gov/study/NCT04204941
- Gounder et al., tazemetostat in advanced epithelioid sarcoma (Lancet Oncology 2020): https://doi.org/10.1016/S1470-2045(20)30451-4

## Connected records

- cancers: [Epithelioid sarcoma](https://onco.cc/cancers/epithelioid-sarcoma/)
- technologies: [Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)](https://onco.cc/technologies/epigenetic-drugs/)
- targets: [EZH2](https://onco.cc/targets/ezh2/)
- drugs: [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Tazemetostat](https://onco.cc/drugs/tazemetostat/)
- companies: [Ipsen](https://onco.cc/companies/ipsen/)

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