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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: Completed Phase 1 study of Synovial Sarcoma and Rhabdoid Tumors, sponsored by Epizyme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The incidence and severity of treatment-emergent adverse events qualifying as protocol-defined dose-limiting toxicities that occurred during the first month of treatment was used to determine the RP2D and/or maximum tolerated dose (MTD) in pediatric patients treated with tazemetostat.
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 |
What the finished NCT02601937 record still lists
NCT02601937 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 147-participant average among 11 other Synovial Sarcoma trials with a reported enrollment target (26% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
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Where NCT02601937's enrollment target sits among peer trials
109 3rd of 11 higher than 9 of 11 other Synovial Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Synovial Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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