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

Johns Hopkins Medicine

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Decitabine; Drug: Cedazuridine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03875287

ASTX727 (Other Identifier)

J18115

IRB00182038 (Other Identifier)

Details and patient eligibility

About

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 35 patients total).

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Decitabine and Cedazuridine

Experimental group

Description:

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.

Treatment:

Drug: Cedazuridine

Drug: Decitabine