NCT04204941

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

Terminated Phase 1 Last updated 7 January 2026

What this trial tests

Phase 1 trial testing Tazemetostat in Advanced Soft-tissue Sarcoma in 25 participants. Terminated before completion.

Timeline

19 December 2019

Primary endpoint
14 June 2024

14 June 2024

Quick facts

Lead sponsor	Epizyme, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	19 December 2019
Primary completion	14 June 2024
Estimated completion	14 June 2024
Sites	21 locations across Taiwan, Canada, United States, United Kingdom

Drugs / interventions tested

• Tazemetostat (tazemetostat) — full drug profile →
• Doxorubicin HCl

Conditions studied

• Advanced Soft-tissue Sarcoma — all drugs for Advanced Soft-tissue Sarcoma →
• Advanced Epithelioid Sarcoma — all drugs for Advanced Epithelioid Sarcoma →

Sponsor

Epizyme, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Soft-tissue Sarcoma or Advanced Epithelioid Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. EZH2: a novel target for cancer treatment.
   Duan R, Du W, Guo W. · · 2020 · cited 652× · PMID 32723346 · DOI 10.1186/s13045-020-00937-8
2. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial.
   Morschhauser F, Tilly H, Chaidos A, McKay P, et al · · 2020 · cited 448× · PMID 33035457 · DOI 10.1016/s1470-2045(20)30441-1
3. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: an international, open-label, phase 2 basket study.
   Gounder M, Schöffski P, Jones RL, Agulnik M, et al · · 2020 · cited 300× · PMID 33035459 · DOI 10.1016/s1470-2045(20)30451-4
4. EZH2-Targeted Therapies in Cancer: Hype or a Reality.
   Eich ML, Athar M, Ferguson JE, Varambally S. · · 2020 · cited 188× · PMID 32978169 · DOI 10.1158/0008-5472.can-20-2147
5. Epigenetics and beyond: targeting writers of protein lysine methylation to treat disease.
   Bhat KP, Ümit Kaniskan H, Jin J, Gozani O. · · 2021 · cited 181× · PMID 33469207 · DOI 10.1038/s41573-020-00108-x
6. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
7. Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
   Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
8. The roles of EZH2 in cancer and its inhibitors.
   Liu Y, Yang Q. · · 2023 · cited 100× · PMID 37148376 · DOI 10.1007/s12032-023-02025-6