Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.
• Treatments: Decitabine

Criteria

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 <1

• Ability to understand and the willingness to sign a written informed consent document.

• Patients must have measurable disease

• Ability to swallow oral medications

Exclusion Criteria:

• 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.