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NCT02601937 · ClinicalTrials.gov registry record · Phase 1

EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

A Phase 1 study of Synovial Sarcoma and Rhabdoid Tumors, sponsored by Epizyme.

Completed
Registry status
Phase 1
Development phase
109
Enrollment target
20
Study locations

NCT02601937 is a Phase 1 study of Synovial Sarcoma and Rhabdoid Tumors that has completed, run by Epizyme. The registered enrollment target is 109 participants, below the 147-participant average among 11 other Synovial Sarcoma trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT02601937, a Phase 1 study of Synovial Sarcoma and Rhabdoid Tumors, has completed, sponsored by Epizyme.

COMPLETED
Registry status
Phase 1
Development phase
109 participants
Enrollment target
20
Study locations

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.

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

FieldValue
Enrollment Target 109 participants
Start Date 2016-01-07
Est. Completion 2021-10-22
Phase Phase 1

Sponsor

Epizyme

16 total trials

What the Registry Record Tells You About NCT02601937

The ClinicalTrials.gov registry entry for NCT02601937 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 147-participant average among 11 other Synovial Sarcoma trials with a reported enrollment target (26% lower). The listed sponsor is Epizyme, which has 16 total studies on file at ClinicalTrials.gov.

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.

NCT02601937 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Massachusetts, Texas.

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.

What interventions are being tested in trial NCT02601937?

The interventions under investigation include: Tazemetostat (DRUG).

Who is sponsoring clinical trial NCT02601937?

This trial is sponsored by Epizyme, which has 16 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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