Status:
RECRUITING
Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Astex Pharmaceuticals, Inc.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03875287
Start Date
April 17 2019
End Date
December 1 2026
Last Update
March 4 2025
Active Locations (2)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231