Phase II Study of Tazemetostat for Solid Tumors with ARID1A Mutation

Sponsor: Prisma Health-Upstate

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05023655

Provider View

This clinical trial is exploring the use of tazemetostat, a drug that targets a specific protein, to treat solid tumors with an ARID1A mutation. The study aims to see if this treatment can provide significant benefits for patients with these types of tumors.

Patient Parameters

Program Overview

This study is testing tazemetostat, a drug that targets a protein called EZH2, in patients with solid tumors that have a mutation in the ARID1A gene. This mutation is common in several types of cancer, including ovarian, uterine, and certain other cancers. Tazemetostat has shown promise in treating other cancers by blocking EZH2, which plays a role in cancer growth. The study aims to see if tazemetostat can help control tumors with the ARID1A mutation.

Description

The ARID1A gene is important for controlling cell growth and repairing DNA. When this gene is mutated, it can lead to cancer. Tazemetostat is a drug that blocks a protein called EZH2, which is often overactive in cancers with ARID1A mutations. By blocking EZH2, tazemetostat may help stop cancer cells from growing.

This study is focused on patients with advanced or metastatic solid tumors that have an ARID1A mutation. These patients have already tried other treatments that did not work or have no other standard treatment options available. The study will evaluate how well tazemetostat works in shrinking tumors and improving patient outcomes.

Participants will receive tazemetostat and will be monitored for any side effects and changes in their cancer. The study will also look at how long patients live without their cancer getting worse and overall survival rates. This research could lead to new treatment options for patients with ARID1A-mutated cancers.

Eligibility Criteria

Inclusion Criteria

  • Agree to participate and sign a consent form.
  • Have a confirmed diagnosis of advanced or metastatic solid tumor with an ARID1A mutation (except epithelioid sarcoma).
  • Cancer has progressed after standard treatments or no standard treatment is available.
  • Any side effects from previous cancer treatments have resolved or are stable.
  • Have measurable cancer as defined by specific criteria.
  • Be in good overall health with a performance status of 0, 1, or 2.
  • Be 18 years or older.
  • Have a life expectancy of more than 3 months.
  • Have waited a specific amount of time after previous cancer treatments before starting tazemetostat.
  • Have adequate kidney, bone marrow, and liver function as determined by blood tests.

Exclusion Criteria

  • Have epithelioid sarcoma.
  • Have a history of certain blood cancers or disorders.
  • Are pregnant or breastfeeding.
  • Have previously taken tazemetostat or similar drugs.
  • Have uncontrolled brain metastases requiring steroids.
  • Are taking certain medications that affect how tazemetostat works.
  • Cannot avoid certain foods like grapefruit.
  • Have had major surgery within 4 weeks before starting the study.
  • Cannot take oral medication or have digestive issues that affect drug absorption.
  • Have significant heart problems or recent heart attack or stroke.
  • Have an active infection requiring treatment.
  • Are allergic to tazemetostat.
  • Have any other major illness that increases risk or affects study participation.
  • Have had a solid organ transplant.
  • Have had another cancer in the past 5 years.

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