A PHASE 2 SINGLE-ARM MULTI-CENTER STUDY OF ENTINOSTAT IN PATIENTS WITH RELAPSED OR REFRACTORY ABDOMINAL NEUROENDOCRINE TUMORS

Protocol: 
AAAR1117
Phase: 
II

A PHASE 2 SINGLE-ARM MULTI-CENTER STUDY OF ENTINOSTAT IN PATIENTS WITH RELAPSED OR REFRACTORY ABDOMINAL NEUROENDOCRINE TUMORS

You are being asked to participate in this study because you have a neuroendocrine tumor that has spread to your organs. You may or may not have had prior treatment for your neuroendocrine tumor. The purpose of this study is to determine if a drug called entinostat has efficacy in shrinking neuroendocrine tumors. People who usually have metastatic neuroendocrine tumors may be treated with octreotide or lanreotide and also with everolimus. There are other ongoing clinical trials with different agents for patients with your kind of disease. Approximately 40 individuals will be asked to participate in this study.

Are you Eligible? (Inclusion Criteria)

1. Pathologic confirmation of relapsed or refractory abdominal
neuroendocrine tumor from the last biopsy available. Relapsed disease is
defined as progressive disease following systematic therapy (ies).
Refractory disease is defined as disease not responding to or having
progressed within 1 month of the last dose of most recent systemic therapy.

2. Documented disease that is radiographically measurable.

3. Last dose of prior therapy must be > 21 days before the first dose of
study drug administration. There is no upper limit to number of prior
therapies. However, the patient must have recovered from acute toxicities
from the most recent therapy to grade 1 or less.

4. ECOG performance status of 0 or 1 (must be done within 7 days prior to
study drug administration).

5. Age 18 years or older

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States