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

Last updated: February 27, 2025
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Neuroblastoma

Treatment

Decitabine

Cedazuridine

Clinical Study ID

NCT03875287
J18115
ASTX727
IRB00182038
  • Ages 18-100
  • All Genders

Study 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 35 patients total).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have advanced, unresectable, and/or metastatic solid tumormalignancy that is histologically or cytologically confirmed.

  • Patients must have received at least 2 lines of therapy in the advanced/metastaticsetting (if 2 lines exist) and have no other possible therapies or refuse therapiesthat have shown clinical benefit for their condition.

  • ECOG performance status <1

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

  • Patients must have measurable disease

  • Ability to swallow oral medications

Exclusion

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.

Study Design

Total Participants: 35
Treatment Group(s): 2
Primary Treatment: Decitabine
Phase: 1
Study Start date:
April 17, 2019
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Active - Recruiting

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland 21231
    United States

    Active - Recruiting

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