Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Neuroendocrine Tumors
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Simon 2-stage design (optimum version)Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

Description

Neuroendocrine tumors (NETs) are derived from NE cells that reside widely in the endocrine system and other organs and comprise a heterogeneous group of neoplasms. Because NETs can arise in a broad spectrum of locations they are associated with a broad range of symptoms that may be caused by mass ef...

Neuroendocrine tumors (NETs) are derived from NE cells that reside widely in the endocrine system and other organs and comprise a heterogeneous group of neoplasms. Because NETs can arise in a broad spectrum of locations they are associated with a broad range of symptoms that may be caused by mass effects and/or by the production of hormones or biogenic amines. Most recently, entinostat has been shown to down-regulate the number and function of two key immunosuppressive cells, myeloid derived suppressor cells (MDSCs) and regulatory T-cells (Tregs), in the tumor microenvironment thereby enhancing the activity of immune checkpoint inhibition. To date, entinostat has been investigated alone or in combination in >900 patients with cancer in clinical studies, including >600 patients with solid tumors. Entinostat as a single agent has been studied in metastatic melanoma and in combination has been studied in metastatic non-small cell lung cancer (NSCLC), breast cancer, renal cell cancer, and colon cancer.

Tracking Information

NCT #
NCT03211988
Collaborators
Not Provided
Investigators
Principal Investigator: Antonio Fojo, MD, PhD Columbia University/Herbert Irving Cancer Center
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