Tazemetostat Expanded Access Program for Adults With Solid Tumors (NCT03874455) | Clinical Trial Compass
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Tazemetostat Expanded Access Program for Adults With Solid Tumors
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
. Female patients of childbearing potential should:
. Male patients with a female partner of childbearing potential should:
Exclusion criteria
. 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.
. Is currently taking any prohibited medication(s) as described in section 6.3.
. Has known hypersensitivity to any of the components of tazemetostat or other inhibitor(s) of EZH2.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Has a prior history of T-LBL/T-ALL.
. For female patients of childbearing potential: Is pregnant or nursing.
. 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.