Tazemetostat for Ovarian or Endometrial Cancer

Recruiting at 658 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A inhibitors, CYP3A inducers

Disqualifiers: Myeloid malignancies, T-cell lymphoma, 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: 3

Duration: Up to 6 months

62 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back. Tazemetostat aims to stop cancer cells from growing and spreading. The trial targets patients whose cancers have returned after initial treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking strong and moderate inhibitors or inducers of CYP3A (a liver enzyme) at least 14 days before starting the study treatment and during the trial. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Tazemetostat for ovarian or endometrial cancer?

Research on epigenetic therapies, which target changes in gene expression, shows promise for treating ovarian cancer. Tazemetostat, as an epigenetic drug, may help overcome drug resistance in ovarian cancer by reversing gene silencing, similar to other epigenetic therapies that have shown potential in preclinical models. ^{1 2 3 4 5}

Research Team

Ramez N Eskander

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with recurrent ovarian or endometrial cancer, specifically endometrioid or clear cell types. Participants must have completed prior treatments and be able to take oral medication. They should not be pregnant, have severe co-morbidities, bowel obstruction, HIV on antiretrovirals, a history of myeloid malignancies or recent therapeutic paracentesis.

Inclusion Criteria

Your blood test results show no major abnormalities in how your blood cells look.

My cancer stage fits the study requirements.

Your white blood cell count is at least 1,500 per microliter.

Exclusion Criteria

Pregnant or lactating patients

I have a history of T-cell lymphoblastic lymphoma or leukemia.

I haven't taken drugs that strongly affect liver enzymes in the last 14 days.

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 in the absence of disease progression or unacceptable toxicity.

Up to 6 months

Monthly visits for treatment and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 3 months for 2 years and then every 6 months for 3 years.

5 years

Every 3 months for 2 years, then every 6 months for 3 years

Treatment Details

Interventions

• Tazemetostat

Trial Overview The trial tests Tazemetostat's effectiveness in treating recurrent ovarian or endometrial cancer. It's a phase II study where the drug aims to stop tumor growth by killing cells or preventing their division and spread. Imaging techniques like MRI and CT scans are used for evaluation.

Participant Groups

Group I: Treatment (tazemetostat) Experimental Treatment 3 Interventions

Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study.

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+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Findings from Research

Pemetrexed (PEM) shows promise in treating recurrent ovarian cancer, particularly when combined with carboplatin, with response rates comparable to other combination therapies, based on eight trials reviewed.

However, due to a lack of randomized trials directly comparing PEM with existing treatments, its definitive efficacy remains uncertain, especially in platinum-resistant cases where PEM may perform similarly to other single-agent therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pemetrexed disodium in ovarian cancer treatment. Morotti, M., Valenzano Menada, M., Venturini, PL., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

A phase II study of vorinostat in the treatment of persistent or recurrent epithelial ovarian or primary peritoneal carcinoma: a Gynecologic Oncology Group study. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Epigenetic therapy for ovarian cancer: promise and progress. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The epigenetics of ovarian cancer drug resistance and resensitization. [2009]

4. England pubmed.ncbi.nlm.nih.gov

Pemetrexed disodium in ovarian cancer treatment. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Combination of enzastaurin and pemetrexed inhibits cell growth and induces apoptosis of chemoresistant ovarian cancer cells regulating extracellular signal-regulated kinase 1/2 phosphorylation. [2021]