Tazemetostat for Ovarian or Endometrial Cancer

Not currently recruiting at 676 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a drug called tazemetostat for patients with recurrent ovarian or endometrial cancer. The drug aims to halt tumor growth by killing tumor cells or preventing them from dividing and spreading. This trial may suit individuals whose ovarian or endometrial cancer persists, particularly if previous treatments have been ineffective. Participants take tazemetostat pills and undergo regular CT or MRI scans to monitor progress. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that tazemetostat is likely to be safe for humans?

Research shows that tazemetostat is generally well-tolerated. Studies have found it safe, with many patients experiencing tumor shrinkage and managing the drug effectively. The FDA has approved tazemetostat for other cancers, indicating a good safety record. Most side effects were mild or moderate, making it a promising option for those with recurring ovarian or endometrial cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tazemetostat is unique because it targets a specific protein involved in cancer growth called EZH2, which is different from most standard treatments like chemotherapy and hormone therapy. Unlike the standard care that broadly attacks fast-growing cells, tazemetostat's targeted action could mean fewer side effects and a more effective treatment for certain patients. Researchers are excited about this treatment because it offers a new approach to tackling ovarian or endometrial cancer, potentially leading to better outcomes with less toxicity.

What evidence suggests that tazemetostat might be an effective treatment for ovarian or endometrial cancer?

Research shows that tazemetostat, the treatment under study in this trial, may help treat recurrent ovarian and endometrial cancer. Studies found that over half of the patients (55%) experienced tumor shrinkage. Additionally, nearly half (49.6%) of the patients did not see their cancer worsen for a year. However, only 10% maintained this status for two years. These results suggest that tazemetostat could effectively slow down or reduce cancer for some patients, particularly in the short term. ^{1 4 6 7 8}

Who Is on the Research Team?

Ramez N Eskander

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03348631

Tazemetostat in Treating Patients With Recurrent Ovarian ... This phase II trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back (recurrent).

2. withpower.com withpower.com/trial/phase-3-adenocarcinoma-2-2019-738c2

Tazemetostat for Ovarian or Endometrial Cancer This trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back. Tazemetostat aims to stop cancer ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20461213

A Study of Tazemetostat in Treating Patients With ... The purpose of this trial is to study how well tazemetostat works in treating patients with ovarian, primary peritoneal, or endometrial cancer that has come ...

4. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/4691

Tazemetostat in Treating Patients with Recurrent Ovarian ... Summary. This phase II trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back (recurrent).

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e19045

Efficacy and safety of oral tazemetostat, an EZH2 inhibitor, ... The results showed a 55% tumor response rate and 49.6% progression-free survival (PFS) at 1 year, but only 10% achieved PFS at 2 years. While ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11559081/

Pharmacology and pharmacokinetics of tazemetostat - PMC Overall, tazemetostat is the first-in-class EZH2 inhibitor approved by the FDA for cancer treatment. Current clinical studies are evaluating combination ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2019.37.15_suppl.11003

Safety and efficacy of tazemetostat, a first-in-class EZH2 ... Tazemetostat, a first-in-class, selective, oral inhibitor of EZH2, has demonstrated tumor regression and favorable safety in phase 1/2 trials.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2020/211723Orig1s000MultidisciplineR.pdf

Multi-Discipline Review - accessdata.fda.gov TAZVERIK (tazemetostat). In summary, the available safety data and exposure-safety analysis demonstrated acceptable safety and tolerability ...