RECRUITING

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

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Conditions

Solid TumorARID1A Gene MutationARID1A mutation; solid tumors; tazemetostat

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-06
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05023655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
  2. * Histologically and/or cytologically confirmed advanced or metastatic solid tumor harboring ARID1A mutation (except epithelioid sarcoma)
  3. * Progression of disease following approved therapies or for which no standard therapy exists
  4. * For subjects who have experienced any clinically significant toxicity related to a prior anticancer treatment (i.e., chemotherapy, immunotherapy, and/or radiotherapy): at the time the subject provides voluntary written informed consent, all toxicities have either resolved to grade 1 per NCI CTCAE Version 5.0 \[11\] OR are clinically stable and no longer clinically significant.
  5. * Have measurable disease as defined by RECIST 1.1.
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  7. * Males or females are \>18 years of age at the time of providing voluntary written informed consent.
  8. * Life expectancy \>3 months before enrollment.
  9. * Time between prior anticancer therapy and first dose of tazemetostat as follows:
  10. * Adequate renal function: Creatinine \< 2.0 or calculated creatinine clearance ≥ 35 mL/minute per the Cockcroft and Gault formula
  11. * Adequate bone marrow function:
  1. * Subjects with epithelioid sarcoma are excluded.
  2. * Has a prior history of T-Cell Lymphoblastic Lymphoma, T-Cell Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Neoplasm.
  3. * Female subjects who are pregnant or breastfeeding.
  4. * Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
  5. * Subjects with uncontrolled CNS metastases requiring steroids.
  6. * Subjects taking medications that are known potent CYP3A4 inducers/inhibitors (including St. John's wort)
  7. * Are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from their diet.
  8. * Major surgery within 4 weeks before the first dose of study drug. NOTE: Minor surgery (e.g., minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment.
  9. * Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat.
  10. * Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II (Appendix 3), uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.
  11. * Have an active infection requiring systemic therapy.
  12. * Known hypersensitivity to any component of tazemetostat.
  13. * Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the subject's participation in this study OR interfere with their ability to receive study treatment or complete the study.
  14. * Subjects who have undergone a solid organ transplant.
  15. * Prior malignancy in the past 5 years.

Contacts and Locations

Study Contact

Julie C Martin, DNP
CONTACT
864-455-3667
julie.martin@prismahealth.org
Jan Kueber, MBA
CONTACT
864-455-3774
jan.kueber@prismahealth.org

Principal Investigator

Ki Chung, MD
PRINCIPAL_INVESTIGATOR
Prisma Health

Study Locations (Sites)

Prisma Health Cancer Institute
Greenville, South Carolina, 29605
United States

Collaborators and Investigators

Sponsor: Prisma Health-Upstate

  • Ki Chung, MD, PRINCIPAL_INVESTIGATOR, Prisma Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-06
Study Completion Date2027-01

Study Record Updates

Study Start Date2022-01-06
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • ARID1A mutation; solid tumors; tazemetostat

Additional Relevant MeSH Terms

  • Solid Tumor
  • ARID1A Gene Mutation