A Phase I Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors
Description
Brief Summary
This is a phase 1 study of the combination of cedazuridine with decitabine in patients with
solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal
hypomethylation and toxicity (up to 30 patients total).
Phase
N/AInclusion and Exclusion Criteria
- Participants must have advanced, unresectable, and/or metastatic solid tumor malignancy that is histologically or cytologically confirmed.
- Patients must have received at least 2 lines of therapy in the advanced/metastatic setting (if 2 lines exist) and have no other possible therapies or refuse therapies that have shown clinical benefit for their condition.
- ECOG performance status <1
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must have measurable disease
- Ability to swallow oral medications
- Participants who have had chemotherapy or radiotherapy within 3 weeks
- Participants may not be receiving any other investigational agents.
- Active hepatitis B or hepatitis C infection.
- Active or untreated gastric or duodenal ulcer
- Symptomatic bowel obstruction within 3 months prior to screening visit.
- Symptomatic ascites in the last 4 weeks Other protocol defined inclusion/exclusion criteria may apply.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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