Tazemetostat for Solid Cancers and Lymphoma

Recruiting at 122 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 inducers/inhibitors

Disqualifiers: Pregnancy, Uncontrolled infection, Myeloid malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well tazemetostat works in children with certain difficult-to-treat cancers that have specific gene mutations. Tazemetostat is a pill that aims to stop cancer cell growth by blocking a specific protein. The goal is to see if this treatment can help these children when other treatments have failed. Tazemetostat is already approved for treating various cancers, including certain brain tumors in children.

Research Team

Susan N Chi

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for patients with relapsed or refractory advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with specific gene mutations (EZH2, SMARCB1, SMARCA4). Participants must have measurable disease and recovered from previous cancer therapies. They need adequate blood counts and organ function and can't have had prior EZH2 inhibitor treatment.

Inclusion Criteria

My cancer can be seen and measured on scans, or if I have neuroblastoma, it shows up on special scans even if not measurable.

My blood counts meet the required levels and I haven't needed platelet transfusions in the last week.

My kidney function is normal or near normal.

Exclusion Criteria

My blood tests do not show signs of specific blood disorders.

I do not have any infections that are currently uncontrolled.

Pregnant or breast-feeding women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tazemetostat orally twice daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• Tazemetostat

Trial Overview The trial tests Tazemetostat's effectiveness in stopping tumor growth by blocking a protein called EZH2. It targets patients whose cancers haven't responded to other treatments and who carry certain genetic mutations that may be affected by this drug.

Participant Groups

Group I: Treatment (tazemetostat) Experimental Treatment 1 Intervention

Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Tazemetostat is already approved in United States, European Union for the following indications:

Approved in United States as Tazverik for:

• Epithelioid sarcoma
• Follicular lymphoma

Approved in European Union as Tazverik for:

• Epithelioid sarcoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Children's Oncology Group

Collaborator

Trials

467

Recruited

241,000+