Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/6/2019 |
| Start Date: | May 2019 |
| End Date: | August 2020 |
| Contact: | Angela Scardina, RN |
| Email: | phase1trials@jhmi.edu |
| Phone: | 443-287-6456 |
A Phase I Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors
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 30 patients total).
solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal
hypomethylation and toxicity (up to 30 patients total).
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.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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