NCT02601937 : A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

OnePhase One

0-21Age 0-21

Sarcoma<br/>CancersCancer LocationSarcoma
Cancers

Treatment | SarcomaSarcoma,Synovial Sarcoma

Trial Overview Read MoreRead more

This trial aims to analyses the use of tumour suppressing medication in children with relapsed or refractory tumours or synovial sarcoma.
 

This trial is treating patients with INI1-Negative Tumors or Synovial Sarcoma.

This is a systemic therapy treatment .

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Commercial Sponsor

Epizyme, Inc.

Summary

This is a Phase I, open-label, dose escalation and dose expansion study with a BID oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study. The study has two parts: Dose Escalation and Dose Expansion.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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