A Phase II Study of Tazemetostat for Recurrent or Persistent Endometrioid or Clear Cell Ovarian Cancer or Uterine Endometrioid Cancer

Full Title

A Phase II Study of Tazemetostat (EPZ-6438) (IND # 138671) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma (CIRB) (NRG-GY014)

Purpose

Tazemetostat is an investigational drug that kills cancer cells by stopping a protein called EZH2 from working. In certain cancers, EZH2 activity is abnormally high. Tazemetostat has been shown to slow the growth of or kill cancer cells in these tumor types.

High levels of EZH2 have been found in both endometrial and ovarian cancers. The purpose of this study is to evaluate the safety and effectiveness of tazemetostat in women with recurrent or persistent ovarian and uterine cancers. Tazemetostat is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have endometrioid or clear cell ovarian cancer or uterine endometrioid cancer that came back or continued to grow despite at least one but no more than three prior regimens of chemotherapy.
  • At least 4 weeks must pass since the completion of chemotherapy or immunotherapy and 2 weeks since radiation therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alison Schram at 646-888-5388.

Protocol

19-193

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators