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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tazemetostat | Drug | Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene |
|
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D018335 | Rhabdoid Tumor |
| D002813 | Chondrosarcoma |
| D002292 | Carcinoma, Renal Cell |
| D013584 | Sarcoma, Synovial |
| D000086002 | Mesothelioma, Malignant |
| D058405 | Desmoplastic Small Round Cell Tumor |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018193 | Neoplasms, Complex and Mixed |
| D009372 | Neoplasms, Connective Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000593333 | tazemetostat |
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