Clinical Trials Logo
  1. Home
  2. Synovial Sarcoma
  3. NCT02601937

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

Synovial Sarcoma Clinical Trial

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

Clinical Trial Summary

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)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02601937
Study type Interventional
Source Epizyme, Inc.
Contact
Status Completed
Phase Phase 1
Start date January 7, 2016
Completion date October 22, 2021
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Terminated NCT01957709 - Recombinant Interferon Gamma in Treating Patients With Soft Tissue Sarcoma Early Phase 1
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Active, not recruiting NCT02869217 - Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors Phase 1
Completed NCT01674101 - Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy N/A
Completed NCT03250325 - Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma Phase 1/Phase 2
Recruiting NCT06094101 - Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision) Phase 1/Phase 2
Terminated NCT03520959 - A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) Phase 3
Terminated NCT02683148 - DHEA in Synovial Sarcoma Patients Phase 1
Recruiting NCT05642455 - SPEARHEAD-3 Pediatric Study Phase 1/Phase 2
Active, not recruiting NCT04420975 - Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma Phase 1
Recruiting NCT02983539 - Detection of Circulating Tumor Cells in Patients With Sarcomas
Recruiting NCT04028479 - The Registry of Oncology Outcomes Associated With Testing and Treatment
Active, not recruiting NCT03132922 - MAGE-A4ᶜ¹º³²T for Multi-Tumor Phase 1
Terminated NCT04145700 - CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma Phase 1/Phase 2
Completed NCT00004853 - Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts After Intensive Chemotherapy Phase 1
Recruiting NCT06083883 - Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1 Phase 1
Terminated NCT05355753 - A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors Phase 1/Phase 2
Withdrawn NCT05116800 - Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma Phase 2
Recruiting NCT03638206 - Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies Phase 1/Phase 2