NO_LONGER_AVAILABLENot Applicable

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 range18 Years

SexALL

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).
✕. 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.

Trial details

NCT IDNCT03874455

SponsorEpizyme, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Epithelioid Sarcoma (Ex-US Only) trials