This is an open-label, single arm, multi-center Phase II trial of entinostat given as a 5 mg oral dose every week (days 1, 8, 15, and 22 of a 4-week cycle) in patients with relapsed or refractory abdominal neuroendocrine (NE) tumors. Patients will continue on treatment until disease progression or intolerable toxicity occurs.
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Pathologically confirmed stage intravenous (IV) unresectable relapsed, or unresectable refractory abdominal neuroendocrine tumor from the last biopsy available which may be the initial diagnostic biopsy.
✓. Eligibility for stage 2 of the study, if the extension stage is opened, will be determined by ribonucleic acid-sequencing (RNA-seq) analysis and master regulator profile of a single fresh needle biopsy specimen obtained during study screening.
✓. Documented disease that is radiographically measurable.
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (must be done within 7 days prior to study drug administration).
✓. Age 18 years or older
✓. Total Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN (results within 7 days before study drug administration), ≤5×ULN for patients with liver metastases.
✓. Serum creatinine ≤ 1.5 x ULN (results within 7 days before study drug administration)
Exclusion criteria
✕. Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia (Cervical Intraepithelial Neoplasia (CIN) / cervical carcinoma in situ) or melanoma in situ)). Prior history of other cancer is allowed, as long as there is no active disease within the prior 5 years.
✕. Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 3 days prior to start of study drug.
✕. Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever \>38.5°C that has not been evaluated for infection up to the day of initial dosing. Patients with documented history of tumor fever are accepted provided acute or chronic infection has been excluded as possible cause of the fever.
✕. Patients who have been treated with any investigational drug within 28 days prior to the first dose of study medication, or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
✕. History of pericarditis or pericardial effusion that had required medical or surgical intervention in the last 6 months, or myocardial infarction or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, or New York Heart Association (NYHA) Class III or IV disease, or a corrected QT (QTc) interval \>0.47 seconds
✕. Known human immunodeficiency virus (HIV) or a history of active Hepatitis B or C as evidenced by laboratory abnormalities in addition to positive serology. Testing is not required for patients not suspected of having these conditions
✕. Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and comply with study procedures