Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors
Running, not enrolling · Phase 1
Conditions studied: Solid Tumor
In brief
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).
Key facts
- Study ID
- NCT03875287
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 35
- Starts
- 2019-04-17
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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