Entinostat Neuroendocrine (NE) Tumor
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|ClinicalTrials.gov Identifier: NCT03211988|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : January 8, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211988
|Contact: Bridget James||(212) firstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Edward Gelmann, MD email@example.com|
|Principal Investigator:||Edward Gelmann, MD||Columbia University|