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 range
18 Years – 99 Years
Sex
ALL
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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