Experimental drug opens door for rare sarcoma patients with no options left
NCT ID NCT04225429
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This program provides tazemetostat, an experimental drug taken as a pill twice daily, to adults with advanced epithelioid sarcoma—a rare cancer—who have no satisfactory alternative treatments. It is designed for people who cannot join other clinical studies or access the drug through regular channels. The goal is to offer a potential treatment option for those in serious need.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tazemetostat
- What this could lead to
- If it works, this could provide a treatment option for people with advanced epithelioid sarcoma who have run out of alternatives.
- What could go wrong
- This is an expanded access program, not a formal trial, so results may be limited. The drug may not work for everyone and could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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