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

Status
Active
Cancer Type
Bone and Soft Tissue (including Sarcoma)
Chondrosarcoma
Trial Phase
Phase I
Eligibility
6 months to 21 years, Male and Female
Study Type
Treatment
NCD ID
NCT02601937
Protocol IDs
EZH-102 (primary)
NCI-2015-02224
Study 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.

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 Expansion at the MTD or the RP2D, for subjects with rhabdoid tumors

(MRT/ATRT/RTK/selected tumors with rhabdoid features).

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