drugset / Trial / NCT03883919
Liposomal Irinotecan Plus 5-FU / LV Combined With Paricalcitol in Patients With Advanced Pancreatic Cancer Progressed on Gemcitabine-based Therapy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Given the efficacy of nanoliposomal irinotecan as a second-line regimen in pancreatic ductal adenocarcinoma (PDAC), together with the favorable toxicity profile of paricalcitol and its interplay with irinotecan metabolism, the investigators propose a second-line pilot study in advanced PDAC that will enroll patients who have progressed on a gemcitabine-based regimen.
Timeline
- Start
- 2019-07-11
- Primary completion
- 2021-03-23
- Completion
- 2022-07-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paricalcitol | Other / unclassified | 7 ug/kg | — |
| Subject | Paricalcitol | Other / unclassified | 75 ug | — |
| Background | Irinotecan | Small molecule | 70 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |