drugset / Trial / NCT04257448
Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
A multi-center, open-label phase I/II study to to determine the safety and tolerability of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine in patients with advanced pancreatic ductal adenocarcinoma (PDAC) (Part 1), followed by sequential immune targeting with programmed death-ligand (PD-L)1 blockade in combination with low-dose Lenalidomide (Part 2) in patients with controlled disease after 3 cycles (Part 1).
Timeline
- Start
- 2020-05-25
- Primary completion
- 2024-07-02
- Completion
- 2024-07-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 20 mg/m2 | Subcutaneous |
| Subject | Azacitidine | Other / unclassified | 30 mg/m2 | Subcutaneous |
| Subject | Azacitidine | Other / unclassified | 40 mg/m2 | Subcutaneous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Romidepsin | Peptide | 2 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 3.3 mg/m2 | Intravenous |
| Subject | Romidepsin | Peptide | 7 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |