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NCT05023655 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation

A Phase 2 study, sponsored by Prisma Health-Upstate.

Terminated
Registry status
Phase 2
Development phase
20
Enrollment target

NCT05023655: Clinical Trial Phase 2 study, sponsored by Prisma Health-Upstate.

NCT05023655 is a Phase 2 study that was terminated before completion, run by Prisma Health-Upstate. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05023655, a Phase 2 study, was terminated before completion, sponsored by Prisma Health-Upstate.

TERMINATED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

The FDA approved targeted agent tazemetostat inhibits EZH2 and induces durable tumor responses in patients with B-cell non-Hodgkin's lymphoma and epithelioid sarcomas. Responses have also been demonstrated in INI1 and SMARCA4 negative solid tumors patients. Since EZH2 plays a critical role in driving the biology of ARID1A mutated malignancies, we hypothesize that inhibition of EZH2 with tazemetostat will lead to significant clinical benefit in ARID1A mutated malignancies.

Primary Outcome

Evidence of anti-tumor activity will be assessed by objective response, as defined by RECIST 1.1. This will be used to summarize ORR (CR+PR), as well as the rates for the individual categories of response, (i.e., CR, PR, SD, and PD).

Interventions

  • DRUG Tazemetostat

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-01-06
Est. Completion 2026-03-06
Phase Phase 2
Prisma Health-Upstate

67 total trials

Why NCT05023655 stopped before completion

NCT05023655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which Tazemetostat is the first listed.

NCT05023655 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05023655 about?

NCT05023655 is a clinical study titled "Phase II Study of Tazemetostat in Solid Tumors Harboring an ARID1A Mutation". The FDA approved targeted agent tazemetostat inhibits EZH2 and induces durable tumor responses in patients with B-cell non-Hodgkin's lymphoma and epithelioid sarcomas. Responses have also been demonstrated in INI1 and SMARCA4 negative solid tumors patients. Since EZH2 plays a critical role in drivin...

What is the current status of trial NCT05023655?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-01-06. Estimated completion is 2026-03-06.

What interventions are being tested in trial NCT05023655?

The interventions under investigation include: Tazemetostat (DRUG).

Who is sponsoring clinical trial NCT05023655?

This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05023655's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05023655, the US trial registry maintained by the National Library of Medicine. NCT05023655 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.