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EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
NCT02601937 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of the enhancer of zeste homolog-2 (EZH2) inhibitor, 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.
Conditions Studied
Interventions
- DRUG Tazemetostat
Study Locations (20)
California
- Children's Hospital of Los Angeles — Los Angeles
- University of California San Francisco - Benioff Children's Hospital — San Francisco
Massachusetts
- Dana Farber Cancer Institute — Boston
- Massachusetts General Hospital - Cancer Center — Boston
Texas
- UT Southwestern Medical Center — Dallas
- Texas Children's Cancer and Hematology Center — Houston
Colorado
- Children's Hospital Colorado — Aurora
District of Columbia
- Children's National Medical Center — Washington D.C.
Georgia
- Children's Healthcare of Atlanta — Atlanta
Illinois
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago
Maryland
- John Hopkins Kimmel Cancer Center — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2016-01-07 |
| Est. Completion | 2021-10-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02601937
The ClinicalTrials.gov registry entry for NCT02601937 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Epizyme, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Synovial Sarcoma appearing as the primary indexed condition, and to 1 intervention — of which Tazemetostat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02601937 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Massachusetts, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02601937 about?
NCT02601937 is a clinical study titled "EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma". This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of the enhancer of zeste homolog-2 (EZH2) inhibitor, tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment ...
What is the current status of trial NCT02601937?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2016-01-07. Estimated completion is 2021-10-22.
What conditions does trial NCT02601937 study?
This clinical trial studies the following conditions: Synovial Sarcoma, Rhabdoid Tumors, INI1-negative Tumors, Malignant Rhabdoid Tumor of Ovary. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02601937?
The interventions under investigation include: Tazemetostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02601937?
This trial is sponsored by Epizyme, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02601937 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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