{"entity":{"id":"tazemetostat-doxorubicin-es","kind":"trial","name":"Tazemetostat with doxorubicin as front-line therapy for advanced epithelioid sarcoma (EZH-301 run-in)","aka":[],"tldr":"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.","status":"completed","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04204941","url":"https://clinicaltrials.gov/study/NCT04204941"},{"label":"Gounder et al., tazemetostat in advanced epithelioid sarcoma (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30451-4"}],"tags":["owner-request"],"related":[],"cancers":["epithelioid-sarcoma"],"sections":[],"technologies":["epigenetic-drugs"],"targets":["ezh2"],"drugs":["tazemetostat","doxorubicin"],"companies":["ipsen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"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,"outcomes":[]},"route":"/trials/tazemetostat-doxorubicin-es/","neighbours":{"cancer":[{"id":"epithelioid-sarcoma","kind":"cancer","name":"Epithelioid sarcoma","route":"/cancers/epithelioid-sarcoma/"}],"technology":[{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"}],"target":[{"id":"ezh2","kind":"target","name":"EZH2","route":"/targets/ezh2/"}],"drug":[{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"tazemetostat","kind":"drug","name":"Tazemetostat","route":"/drugs/tazemetostat/"}],"company":[{"id":"ipsen","kind":"company","name":"Ipsen","route":"/companies/ipsen/"}]}}