Tazemetostat in Advanced Epithelioid Sarcoma

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

Agents: Tazemtostat
Phase III
Status  Recruiting
Sponsor Epizyme, Inc


Further information: https://www.clinicaltrials.gov/ct2/show/NCT04204941?term=tazemetostat&cond=sarcoma&phase=2&draw=2&rank=1 


This is an international, double-blind and randomized phase 3 study to evaluate the efficacy and safety of tazemetostat + doxorubicin vs placebo + doxorubicin in patients with advanced epithelioid sarcoma (ES). 

WHO is the trial for?

  • Patients of 18 years or older with Epithelioid Sarcoma
  • Patients mus have measurable disease
  • Patients who did not have prior systemic therapy

WHAT is the key question that this trial is attempting to answer?

This study aims to investigate a drug called tazemtostat, a selective EZH2 inhibitor, in combination with doxorubicin. The trial tries to find out whether the combination of tazemetostat and doxorubicin is more effective than doxorubicin alone, the current standard in first-line therapy in locally advanced unresectable or metastatic ES. In addition, safety and tolerability of the drug(s) is assessed.

WHY patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN will the trial be open?

Phase III of this study is open for recruitment.

WHERE is the trial available?

The trial is being conducted in several study centers in the US, Canada, Taiwan and the UK. For further information please check here: https://www.clinicaltrials.gov/ct2/show/NCT04204941?term=tazemetostat&cond=sarcoma&phase=2&draw=2&rank=1

Study contact: (US)-617-229-7575; clinicaltrials@epizyme.com


STUDY DESIGN: What does the study look like?

This study has two study arms: all participating patients will be randomly divided (by a computer) in two groups.

The first group will receive tazemetostat + doxorubicin, the other group receives doxorubicin + placebo. 

Tazemetostat 800 mg will be given orally twice daily in continuous 21-day cycles during cycles 1-6 and in continuous 28-day cycles during cycle 7 and beyond. Doxorubicin will be given in a dosing of 75 mg/m2 IV on day 1 of cycles 1-6. 

HOW do I get more information?

Patient organisations supporting sarcoma and/or GIST patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving GIST and/or sarcoma patients. If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.eu

CONNECT with other patients on this trial

If you want to connect with other patients considering or participating in this trial, you can find them here.

SHARE your experience

You want to share your experience on this trial?
Send us an e-mail to: info@sarcoma-patients.eu
Note that your experience would be helpful for other patients and patient organisations.

RESULTS of the study

Not yet available.

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.


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