A Phase I/II Study of E7438 in Patients with Advanced Solid Tumors or B-Cell Lymphomas

Full Title

An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat E7438 (EZH2 Histone Methyl Transferase [HMT] Inhibitor) as a Single Agent in Subjects With Advanced Solid Tumors or With B Cell Lymphomas and Tazemetostat in Combination with Prednisolone in Subjects with Diffuse Large B-Cell Lymphoma

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the investigational drug E7438 (also known as EPZ-6438) in patients with persistent or recurrent advanced solid tumors or B-cell lymphomas. E7438 works against cancer cells by inhibiting a protein involved in cancer cell growth called EZH2.

Phase I of the study will include patients with advanced solid tumors and lymphomas, while phase II will include only lymphoma patients. E7438 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 an advanced solid tumor or B-cell lymphoma that has continued to grow or came back after therapy, or for which no curative therapy exists.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • For the phase I portion: 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.
  • For the phase II portion: Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. John Gerecitano at 212-639-3748.

Protocol

16-1002

Phase

I/II

Investigator

Co-Investigators

Diseases