A Phase IB Study of Tazemetostat Combined with Enzalutamide or Abiraterone/Prednisone in Men with Advanced Prostate Cancer

Share
Print

Full Title

A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination with Enzalutamide or Abiraterone/Prednisone in Chemotherapy-Naïve Subjects with Metastatic Castration Resistant Prostate Cancer

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers” (CRPC).

In this study, researchers want to find out whether the drug tazemetostat is a safe treatment for metastatic CRPC, and whether combining tazemetostat with one of the standard drug treatments for advanced prostate cancer (either enzalutamide or abiraterone acetate/prednisone) is more effective than either of the standard drugs given alone.

Researchers will find the highest dose of tazemetostat that can be given safely with enzalutamide or abiraterone acetate/prednisone. Patients will receive tazemetostat with either enzalutamide or abiraterone acetate/prednisone, depending on their prior prostate cancer treatment. All of these medications are taken orally. Tazemetostat is used to treat certain forms of sarcoma and lymphoma; its use in this study is considered investigational.

Eligibility

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

  • Patients must have metastatic CRPC.
  • Patients may not have previously received chemotherapy for advanced prostate cancer.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Wassim Abida at 646-497-9068.

Protocol

20-050

Phase

I/II

Investigator

Co-Investigators