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

  • End date
    Jan 28, 2023
  • participants needed
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 2 February 2022
measurable disease


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).

Condition Solid Tumor
Treatment Decitabine, Cedazuridine
Clinical Study IdentifierNCT03875287
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on2 February 2022


Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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