Epithelioid SarcomaNCT04225429
Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma
A study testing Tazemetostat in people with Epithelioid Sarcoma, run by Epizyme, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epithelioid Sarcoma
- What is being tested?
- Tazemetostat
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Age (at the time of consent): ≥18 years of age.
- They are unable to participate in tazemetostat clinical trials for their condition.
- Can provide signed written informed consent.
- Morphology and immunophenotypic panel consistent with epithelioid sarcoma (e.g., CD34, epithelial embrane antigen [EMA], Keratin, and INI1).
- 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
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- 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.
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Epithelioid Sarcoma
- Being tested
- Tazemetostat
- Keywords
- Epithelioid Sarcoma, Oncology, SMARC-B, loss of INI 1, EZH2, Expanded Access, Compassionate Use
- Medical subject headings
- Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TazemetostatDrug
800mg/dose taken orally twice every day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelioid SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Epizyme, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225429
- Sponsor's protocol ID
- EZH-801
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2020
- Last updated
- 2 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tazemetostat Expanded Access Program for Adults With Epithelioid Sarcoma
- ClinicalTrials.gov ID
- NCT04225429
- Acronym / sponsor ID
- EZH-801
- Conditions
- Epithelioid Sarcoma
- Keywords
- Epithelioid Sarcoma, Oncology, SMARC-B, loss of INI 1, EZH2, Expanded Access, Compassionate Use
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Epizyme, Inc.Industry (pharma, biotech, devices)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age (at the time of consent): ≥18 years of age.
- They are unable to participate in tazemetostat clinical trials for their condition.
- Can provide signed written informed consent.
- Morphology and immunophenotypic panel consistent with epithelioid sarcoma (e.g., CD34, epithelial embrane antigen [EMA], Keratin, and INI1).
- Female patients of childbearing potential should:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tazemetostat800mg/dose taken orally twice every day. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
Questions about this trial
What is this clinical trial studying?
A study testing Tazemetostat in people with Epithelioid Sarcoma, run by Epizyme, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.