Extract

Dose Escalation: To determine the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D) of tazemetostat when administered as an oral suspension twice daily (BID) in pediatric subjects with relapsed/refractory rhabdoid tumors, integrase interactor 1 (INI1)-negative tumors or synovial sarcoma Dose Expansion: To evaluate the antitumor activity of tazemetostat as assessed by overall response rate (ORR) in pediatric subjects with relapsed/refractory atypical teratoid rhabdoid tumor (ATRT) (Cohort 1), non-ATRT rhabdoid tumors (Cohort 2), and INI1-negative tumors or synovial sarcoma (Cohort 3) using disease appropriate standardized response criteria.

Inclusion criteria

• Atypical teratoid rhabdoid tumor (ATRT), Malignant rhabdoid tumor (MRT), Rhabdoid tumor of kidney (RTK), selected tumors with rhabdoid features.
• 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

Links

• euctr
• euctr
• euctr