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Clinical Trial Detail

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

Complete title: SC-4007,EZH-102, A Phase I Study of the EZH2 Inhibitor Tazemtostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

Research Study Number SC-4007
Principal Investigator Navin Pinto, MD
Phase I

Research Study Description

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).

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number SC-4007
Contact Advanced Therapeutics Study Line
Telephone 206/987-2553

Keywords: Pediatric Cancers, Miscellaneous; Sarcoma; Solid Tumors; Sarcoma, Synovial; Urogenital Neoplasms; Neoplasms, Connective and Soft Tissue; Genital Neoplasms, Female; Endocrine Gland Neoplasms; Adnexal Diseases; Rhabdoid Tumor; Neoplasms, Complex and Mixed

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