A Phase I Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) with Oral Decitabine in Subjects with Solid Tumors (ASTX727)
Johns Hopkins Kimmel Cancer Center in Baltimore
To assess safety and tolerability of combination cedazuridine with decitabine in patients with solid tumor.To determine the phase II dose of the combination of cedazuridine and decitabine.
Inclusion 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 less than 1Ability to understand and the willingness to sign a written informed consent document.Patients must have measurable diseaseAbility to swallow oral medicationsExclusion Criteria:Participants who have had chemotherapy or radiotherapy within 3 weeksParticipants may not be receiving any other investigational agents.Active hepatitis B or hepatitis C infection.Active or untreated gastric or duodenal ulcerSymptomatic bowel obstruction within 3 months prior to screening visit.Symptomatic ascites in the last 4 weeks
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).Treatment will be administered on an outpatient basis. Cycle length is 28 days. The dose of cedazuridine is fixed at 100mg and the dose and duration of decitabine will vary depending on when a patient enters the study.
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