Entinostat Neuroendocrine (NE) Tumor
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|ClinicalTrials.gov Identifier: NCT03211988|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Entinostat||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Simon 2-stage design (optimum version)|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Single-Arm Multicenter Study of Entinostat in Patients With Relapsed or Refractory Abdominal Neuroendocrine (NE) Tumors|
|Actual Study Start Date :||December 23, 2017|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2021|
Eligible patients will be enrolled according to Simon's two-stage design. The dose of Entinostat is 5 mg (one tablet) orally, once every week in a 28 day cycle.
Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
- Objective Response Rate (ORR) [ Time Frame: Up to Two Years ]Percentage of patients who experience a tumor size reduction from the time of initial response to tumor progression.
- Duration of Progression-Free Survival (PFS) [ Time Frame: Up to Two Years ]Time from study enrollment until disease progression or death.
- Duration of Overall Survival (OS) [ Time Frame: Up to Two Years ]The length of time from either the date of diagnosis or start of treatment that years patients diagnosed with the disease are still alive.
- Duration of Response for Patients who Achieve Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to Two Years ]Time from documentation of tumor response to disease progression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211988
|Contact: Lisa Olmos, RN||(212) firstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Antonio Fojo, MD, PhD email@example.com|
|Principal Investigator:||Antonio Fojo, MD, PhD||Columbia University/Herbert Irving Cancer Center|