Clinical trial · Interventional
Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors
A Phase I Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors
NCT03875287CI-TRIAL-00100593active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cedazuridine | Drug | — | UNRESOLVED |
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine and Cedazuridine
- description
- 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.
- interventionNames
- Drug: Decitabine
- Drug: Cedazuridine
Primary outcomes (2)
- measure
- Safety and tolerability of combination cedazuridine with decitabine as assessed by number of participants who experience adverse events
- timeFrame
- up to 2 years
- description
- Number of participants who have experienced grade 3 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
- measure
- Maximum Tolerated Dose (MTD) as determined by number of participants with of dose limiting toxicities (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.