a study on Malignant Rhabdoid Tumor Rhabdoid Tumors of the Kidney (RTK) Atypical Teratoid Rhabdoid Tumor Selected Tumors With Rhabdoid Features Sarcoma INI1-negative Tumors Renal Medullary Carcinoma Solid Tumor
This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID administered orally in continuous 28 day cycles. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. Eligible subjects will be enrolled into one of fivecohorts based on tumor type: - Cohort 1: MRT, RTK, ATRT, or selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant rhaboid tumor of the ovary [MRTO] - Cohort 2: Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement - Cohort 3: Other INI1 negative tumors or any solid tumor with an EZH2 gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma - Cohort 4: Renal medullary carcinoma (RMC) - Cohort 5: Epithelioid sarcoma (ES) Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 8 weeks of treatment and then every 8 weeks thereafter while on study.
Malignant Rhabdoid Tumors (MRT) Rhabdoid Tumors of the Kidney (RTK) Atypical Teratoid Rhabdoid Tumors (ATRT) Selected Tumors With Rhabdoid Features Synovial Sarcoma INI1-negative Tumors Malignant Rhabdoid Tumor of Ovary Renal Medullary Carcinoma Epithelioid Sarcoma Any Solid Tumor With an EZH2 GOF Mutation
Open to people ages 16 years and up
Has a malignancy:
Prior therapy(ies), if applicable, must be completed according to the criteria below:
Has adequate hematologic (bone marrow [BM] and coagulation factors), renal and hepatic function as defined by criteria below:
Has known active CNS or any leptomeningeal metastasis of primary extra-cranial tumor
Has had a symptomatic venous thrombosis within the 3 months prior to study enrollment
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