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Lysine

Dose Escalation: Level 1 (Starting Dose) Oral Tazemetostat 240 mg/m\^2 BID; Level 2 Oral Tazemetostat 300 mg/m\^2 BID; Level 3 Oral Tazemetostat 400 mg/m\^2 BID; Level 4 Oral Tazemetostat 520 mg/m\^2 BID; Level 5 Oral Tazemetostat 700 mg/m\^2 BID; Level 6 Oral Tazemetostat 900 mg/m\^2 BID; Level 7 Oral Tazemetostat 1200 mg/m\^2 BID

Dose Expansion:

Cohort 1: Oral tazemetostat 1200mg/m2 BID Cohort 2: Oral tazemetostat 520mg/m2 BID Cohort 3: Oral tazemetostat 520mg/m2 BID Cohort 4: Oral tazemetostat 800mg/m2 TID (2400mg/m2/day)

Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.

Tazemetostat

This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) 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.

Dose escalation for subjects with the following relapsed/refractory malignancies:

* Rhabdoid tumors:
* Atypical teratoid rhabdoid tumor (ATRT)
* Malignant rhabdoid tumor (MRT)
* Rhabdoid tumor of kidney (RTK)
* Selected tumors with rhabdoid features
* INI1-negative tumors:
* Epithelioid sarcoma
* Epithelioid malignant peripheral nerve sheath tumor
* Extraskeletal myxoid chondrosarcoma
* Myoepithelial carcinoma
* Renal medullary carcinoma
* Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor approval)
* Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment.

Dose Expansion at the MTD or the RP2D

* Cohort 1 - ATRT (closed to enrollment)
* Cohort 2 - MRT/RTK/selected tumors with rhabdoid features (closed to enrollment)
* Cohort 3 - INI-negative tumors:

  * Epithelioid sarcoma
  * Epithelioid malignant peripheral nerve sheath tumor
  * Extraskeletal myxoid chondrosarcoma
  * Myoepithelial carcinoma
  * Renal medullary carcinoma
  * Chordoma (poorly differentiated or de-differentiated)
  * Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval
* Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement (closed to enrollment)

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

The incidence and severity of treatment-emergent adverse events (AEs) qualifying as protocol-defined DLTs in Cycle 1 will guide establishment of the protocol defined RP2D and/or MTD

Epizyme, Inc.

Spots Global Cancer Trial Database for rhabdoid tumors