Experimental drug tazemetostat offered to patients with rare, aggressive tumors
NCT ID NCT03874455
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This expanded access program provides tazemetostat, a drug that blocks a protein called EZH2, to adults with serious or life-threatening solid tumors that have lost the INI1 or SMARCA4 protein. Eligible patients must have tried other treatments without success and cannot join a formal clinical trial. The goal is to offer a potential option when no standard therapies remain.
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 rare, aggressive tumors who have run out of standard therapies.
- What could go wrong
- This is an expanded access program, not a formal trial, so results are limited and may not prove effectiveness. Tazemetostat may cause side effects and not shrink tumors.
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.
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. 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 childbearing potential should: * Agree to practice one highly effective method of contraception 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: 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 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 4.03 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 time of enrollment in study to 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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