Phase 1b/3 of Tazemetostat/Doxorubicin in Advanced Epithelioid Sarcoma
Research type
Research Study
Full title
A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
IRAS ID
273166
Contact name
Robin Jones
Contact email
Sponsor organisation
Epizyme, Inc.
Eudract number
2019-003648-55
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 8 months, 5 days
Research summary
Tazemetostat is a selective small inhibitor of the histone-lysine methyltransferase enzyme (a protein) EZH2 and is being developed as a treatment for patients with Epithelioid Sarcoma (ES), an ultra-rare and aggressive form of soft-tissue sarcoma (STS). Soft-tissue sarcomas represent only 1% of all cancer diagnoses, of which ES represent <1%.
This is a global Phase 1b and Phase 3 Clinical trial, where approximately 154 patients are expected to be enrolled at 46 centres across North America, Europe and Asia-Pacific.
The Phase 1b portion of the study is open-label (the patient and research team will know what drug the patient receives), designed to evaluate the effectiveness and safety of the combination of Tazemetostat and a approved cancer drug (Doxorubicin) and establish the recommended Phase 3 dose. The Phase 1b will consist of a screening, treatment and follow-up period. The treatment period will consist of dose-escalation with a starting dose of 400mg, followed by 600mg and then 800mg (Twice daily).
The Phase 3 portion is double-blind (the patient or the research team will not know what treatment the patient receives), placebo controlled study designed to compare the effectiveness of Tazemetostat + Doxorubicin against the current standard treatment, Doxorubicin + Placebo. The Phase 3 portion consists of a screening, treatment and follow-up period. At the completion of the treatment period (disease progression) patients will be followed up every 12 weeks for at least 2 years.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0153
Date of REC Opinion
17 Aug 2020
REC opinion
Further Information Favourable Opinion