ACTIVE_NOT_RECRUITING

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

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Conditions

Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase I Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors

Quick Facts

Study Start:2019-04-17
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03875287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must have advanced, unresectable, and/or metastatic solid tumor malignancy that is histologically or cytologically confirmed.
  2. * 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.
  3. * ECOG performance status \<1
  4. * Ability to understand and the willingness to sign a written informed consent document.
  5. * Patients must have measurable disease
  6. * Ability to swallow oral medications
  1. * Participants who have had chemotherapy or radiotherapy within 3 weeks
  2. * Participants may not be receiving any other investigational agents.
  3. * Active hepatitis B or hepatitis C infection.
  4. * Active or untreated gastric or duodenal ulcer
  5. * Symptomatic bowel obstruction within 3 months prior to screening visit.
  6. * Symptomatic ascites in the last 4 weeks

Contacts and Locations

Principal Investigator

Nilofer Azad, MD
PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Nilofer Azad, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-17
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2019-04-17
Study Completion Date2027-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumor