ClinicalTrials.gg
No longer availableNCT03874455Updated Jul 2, 2026

Tazemetostat Expanded Access Program for Adults With Solid Tumors

An expanded access record providing Tazemetostat in Epithelioid Sarcoma (Ex-US Only), Spindle Cell Sarcoma and Sinonasal Carcinoma, sponsored by Epizyme, Inc.. No longer available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Epizyme, Inc. (part of Ipsen) · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
18 Years and older
Sex
All
01

Study summary

Patients with a diagnosis listed under "conditions" below are eligible to be considered for the EAP. These conditions must be serious or life-threatening at the time of enrollment and appropriate, comparable, or satisfactory alternative treatments must have been tried without clinical success. Patients with conditions not listed under "conditions" below are not eligible for the tazemetostat EAP.

02

Conditions studied

  • Epithelioid Sarcoma (Ex-US Only)
  • Spindle Cell Sarcoma
  • Sinonasal Carcinoma
  • Small Cell Carcinoma of the Ovary Hypercalcemic Type
  • Thoracic Sarcoma
  • Poorly Differentiated Chordoma
  • ATRT
  • Malignant Rhabdoid Tumor of Kidney
  • Malignant Rhabdoid Tumor of Ovary
  • Malignant Rhabdoid Tumor
  • Myxoid Spindle Cell Sarcoma
  • Epithelioid Malignant Peripheral Nerve Sheath Tumor
  • Chondrosarcoma
  • Renal Cell Carcinoma
  • Myoepithelial Carcinoma
  • Synovial Sarcoma
  • Renal Medullary Carcinoma
  • Malignant Mesothelioma
  • Desmoplastic Small Round Cell Tumor (DSRCT)
  • Intramedullary Spinal Cord Schwannomatosis
03

In context

Sarcoma

1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.

Browse Sarcoma studies →

Lead sponsor

Epizyme, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 9 (75%) have results posted.

First submitted before Epizyme, Inc. became part of Ipsen.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  4. Documented loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable.
  5. Female patients of should:

    • Agree to practice one highly effective method of and one additional effective (barrier, for example condom or diaphragm with spermicide) method 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 first dose of tazemetostat until 30 days following the last dose of tazemetostat, or
    • Have a female partner who is NOT of childbearing potential.

Exclusion criteria

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 to while on the EAP.
  2. Is currently taking any prohibited medication(s) as described in section 6.3.
  3. Has known to any of the components of tazemetostat or other inhibitor(s) of EZH2.
  4. Has thrombocytopenia, neutropenia, or anemia of grade ≥3 (per 4.03 criteria) within the past month, or any prior history of myeloid , 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 : Is pregnant or nursing.
  8. For male patients: Is unwilling to adhere to criteria from time of enrollment in study to at least 30 days after last dose of tazemetostat.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene

    Also known as: EPZ-6438

06

Where to request access

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT03874455
Lead sponsor
Epizyme, Inc.
Responsible party
Sponsor
First posted
Mar 14, 2019
Last update
Jul 2, 2026

Study contacts

Ipsen Medical Director
study director · Ipsen
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion