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| Diagnosis | Rhabdoid Tumor, INI1-negative Tumors, Synovial Sarcoma, Malignant Rhabdoid Tumor, Epithelioid sarcoma, Epithelioid malignant peripheral nerve sheah tumor, Extraskeletal myxoid chondrosarcoma, myoepithelial carcinoma, Renal medullary carcinoma, | Study Status | Closed to enrollment |
| Phase | I |
| Age | Child - (6 Months to 17 Years) | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | oral (suspension and tablets) |
| Last Posted Update | 2021-10-19 |
| ClinicalTrials.gov # | NCT02601937 |
International Sponsor
Epizyme, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel MorgensternCentres
Study Description
Some rare cancer such as rhabdoid tumors or epithelioid sarcoma have been shown to have a molecular dysfunction allowing a protein called EZH2 to favour tumour developpment. Tazemetostat is an EZH2 inhibitor and is expected to slow or stop the growth of cancer cells. The aim of this Phase I study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of Tazemetostat in children with refractory or relapsed solid cancer for which no standard therapy is available or for which the subject is not eligible for the existing therapy.
Inclusion Criteria
- Age ≥6 months to <18 years
- Patient has one of the specific disease targeted in this study, histologically confirmed by a CLIA/CAP certified laboratory
- Relapsed or refractory disease and no standard treatment options as determined by locally or regionally available standards of care and treating physician's discretion
- Patient is able to swallow and retain orally administered medication
Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.
