Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors
NCT ID: NCT03875287
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
35 participants
INTERVENTIONAL
2019-04-17
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
OTHER
NONE
Study Groups
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Decitabine and Cedazuridine
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.
Decitabine
DOSING REGIMEN(S):
Level -1 10mg daily days 1-4
Level 1 10mg daily days 1-5
Level 2 15mg daily days 1-5
Level 3 20mg daily days 1-5
Level 4 25 mg daily days 1-5
Cedazuridine
DOSING REGIMEN(S):
Level -1 100mg daily days 1-4
Level 1 100mg daily days 1-5
Level 2 100mg daily days 1-5
Level 3 100mg daily days 1-5
Level 4 100mg daily days 1-5
Interventions
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Decitabine
DOSING REGIMEN(S):
Level -1 10mg daily days 1-4
Level 1 10mg daily days 1-5
Level 2 15mg daily days 1-5
Level 3 20mg daily days 1-5
Level 4 25 mg daily days 1-5
Cedazuridine
DOSING REGIMEN(S):
Level -1 100mg daily days 1-4
Level 1 100mg daily days 1-5
Level 2 100mg daily days 1-5
Level 3 100mg daily days 1-5
Level 4 100mg daily days 1-5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
100 Years
ALL
No
Sponsors
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Astex Pharmaceuticals, Inc.
INDUSTRY
Stand Up To Cancer
OTHER
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Nilofer Azad, MD
Role: PRINCIPAL_INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00182038
Identifier Type: OTHER
Identifier Source: secondary_id
ASTX727
Identifier Type: OTHER
Identifier Source: secondary_id
J18115
Identifier Type: -
Identifier Source: org_study_id
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