Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma

March 21, 2024 updated by: Epizyme, Inc.
A multicenter, open-label expanded access program to provide access to tazemetostat to Epithelioid Sarcoma (ES) patients in serious need who are otherwise unable to participate in a clinical study or whom access is not available through marketed product in the US.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Patients with epithelioid sarcoma (ES) are eligible to enroll in the EAP. The patient with ES must have an advanced disease that is considered life threatening at the time of enrollment and appropriate, comparable, or satisfactory alternative treatments must have been tried without clinical success. Patients with conditions other than ES are not eligible for the tazemetostat EAP.

Inclusion Criteria:

  1. Age (at the time of consent): ≥18 years of age.
  2. They are unable to participate in tazemetostat clinical trials for their condition.
  3. Can provide signed written informed consent.
  4. Morphology and immunophenotypic panel consistent with epithelioid sarcoma (e.g., CD34, epithelial embrane antigen [EMA], Keratin, and INI1).

  5. Female patients of childbearing potential should:

    • Agree to practice one highly effective method of contraception and one additional effective barrier method (eg, condom or diaphragm with spermicide) at the same time, from the time of providing voluntary written informed consent through 30 days or 5 half-lives (whichever is longer) after the last dose of tazemetostat, and
    • Have a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of tazemetostat (urine or serum test is acceptable however, positive urine tests must be confirmed with serum testing), and
    • Agree to use effective contraception from start of screening until 30 days following the last dose of tazemetostat and have a male partner who uses a condom, or
    • Practice true abstinence, (when this is in line with the preferred and usual lifestyle of the patient) or
    • Have a male partner who is vasectomized.

  6. Male patients with a female partner of childbearing potential should:

    • Be vasectomized, or
    • Agree to use condoms from at least 7 days prior to initiating and during tazemetostat treatment and for at least 30 days following the last dose of tazemetostat, or
    • Have a female partner who is NOT of childbearing potential.

Exclusion Criteria:

  • 1. Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from time of enrollment while on the EAP.

    2. Is currently taking any prohibited medication(s) as described in Section 6.3 of the protocol.

    3. Has known hypersensitivity to any of the components of tazemetostat or other inhibitor(s) of EZH2.

    4. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE v5.0 criteria) within the past month, or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).

    5. Is known to have any abnormalities associated with MDS (e.g. del 5q, chr 7 abn) and MPN (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing.

    6. Has a prior history of T-LBL/T-ALL. 7. For female patients of childbearing potential: Is pregnant or nursing. 8. For male patients: Is unwilling to adhere to contraception criteria from at least 7 days prior to initiating and during tazemetostat treatment and for at least 30 days after last dose of tazemetostat.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epizyme, Inc.

Collaborators

WEP Clinical

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

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

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EZH-801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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