Combination treatment of E7727 and decitabine for patients 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
This study is testing a new combination of two medications, E7727 and decitabine, to see if it can safely help people with advanced solid tumors who have already tried other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT03875287 on ClinicalTrials.gov |
What this trial studies
This phase 1 study evaluates the safety and optimal dosing of E7727, an oral cytidine deaminase inhibitor, in combination with oral decitabine for patients with advanced solid tumors. The trial aims to enroll up to 35 patients, assessing both the hypomethylation effects and toxicity of the treatment. Participants must have previously received at least two lines of therapy and have measurable disease. The study will help determine the best dosage for future trials.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced, unresectable, or metastatic solid tumors who have exhausted standard treatment options.
Not a fit: Patients who have recently undergone chemotherapy or radiotherapy, or those with active infections or certain gastrointestinal conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies involving hypomethylating agents have shown promise in treating solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 1 other locations
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Nilofer Azad, MD — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study coordinator: Danielle Wendler
- Email: phase1trials@jhmi.edu
- Phone: 410-502-5140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.