NCT06387342 Namodenoson Treatment of Advanced Pancreatic Cancer
| NCT ID | NCT06387342 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Can-Fite BioPharma |
| Condition | Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-10 |
| Primary Completion | 2026-07-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is an open-label trial in patients with advanced pancreatic cancer. The trial will evaluate the safety, clinical activity, and pharmacokinetics of the study drug, namodenoson, in this group of patients.
Eligibility Criteria
Inclusion Criteria: 1. Males and females at least 18 years of age. 2. Histologically or cytologically confirmed pancreatic adenocarcinoma, or clinically diagnosed based upon scan results and a serum Cancer Antigen 19-9 value \>1000 U/mL on at least 1 occasion. 3. Pancreatic adenocarcinoma is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative. 4. Pancreatic adenocarcinoma has progressed on at least 1 prior systemic treatment regimen, or the patient refuses standard treatment. 5. Prior pancreatic adenocarcinoma treatment was discontinued for at least 14 days prior to the Baseline Visit. 6. Measurable or evaluable disease by RECIST v1.1. 7. Patients with a history of treated central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: disease outside the CNS is present; there is no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic st