Tazemetostat for Ovarian or Endometrial Cancer
Trial Summary
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.12345
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.
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Treatment Details
Interventions
- Tazemetostat
Tazemetostat is already approved in United States, European Union for the following indications:
- Epithelioid sarcoma
- Follicular lymphoma
- Epithelioid sarcoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator