Spots Global Cancer Trial Database for A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Official Title: A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Study ID: NCT02601937
Interventions
Study Description
Brief 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)
Detailed Description:
Keywords
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Los Angeles, Los Angeles, California, United States
University of California San Francisco - Benioff Children's Hospital, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
John Hopkins Kimmel Cancer Center, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital - Cancer Center, Boston, Massachusetts, United States
Memorial Sloan Kettering, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Oregon Health & Science University (OHSU), Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital, Inc., Memphis, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Texas Children's Cancer and Hematology Center, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Sydney Children's Hospital, Sydney, New South Wales, Australia
Lady Cilento/Queensland Children's Hospital, South Brisbane, Queensland, Australia
The Royal Children's Hospital, Melbourne, Victoria, Australia
The Childrens Hospital at Westmead Oncology Unit, Westmead, , Australia
The Hospital for Sick Children, Toronto, Ontario, Canada
Rigshospitalet Department of Oncology Blegdamsvej, Copenhagen, , Denmark
Institut Curie, Paris, , France
Institut Gustave Roussy, Villejuif, , France
Children's Hospital Augsburg Klinikum, Augsburg, , Germany
Charite - Universitatsmedizin Berlin, Berlin, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Westfalische Wilhelms - Universitat Munster Padiatrische, Munster, , Germany
Istituto Giannina Gaslini- UOSD Centro di Neuro-Oncologia, Genova, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, , Netherlands
Prinses Maxima Centrum voor Kinderoncologie, Utrecht, , Netherlands
Great Ormond Street Hospital for Children NHS Foundation Trust, London, , United Kingdom
Central Manchester University Hospital - Royal Manchester Children's Hospital, Manchester, , United Kingdom
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
