Tazemetostat Expanded Access Program for Adults With Solid Tumors

NCT ID: NCT03874455

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief 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.

Conditions

Epithelioid Sarcoma (Ex-US Only); Spindle Cell Sarcoma; Sinonasal Carcinoma; Small Cell Carcinoma of the Ovary Hypercalcemic Type; Thoracic Sarcoma; Poorly Differentiated Chordoma; ATRT; Malignant Rhabdoid Tumor of Kidney; Malignant Rhabdoid Tumor of Ovary; Malignant Rhabdoid Tumor; Myxoid Spindle Cell Sarcoma; Epithelioid Malignant Peripheral Nerve Sheath Tumor; Chondrosarcoma; Renal Cell Carcinoma; Myoepithelial Carcinoma; Synovial Sarcoma; Renal Medullary Carcinoma; Malignant Mesothelioma; Desmoplastic Small Round Cell Tumor (DSRCT); Intramedullary Spinal Cord Schwannomatosis

Interventions

Tazemetostat

Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene

Intervention Type: DRUG

Other Intervention Names

EPZ-6438

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epizyme, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Other Identifiers

EZH-701

Identifier Type: -

Identifier Source: org_study_id