Phase I/II Study of Vitamin D Receptor Agonist Paricalcitol Plus Gemcitabine and Nab-paclitaxel in Patients With Metastatic Pancreatic Cancer
Summary
The purpose of this phase I/II study is to evaluate the safety and efficacy of paricalcitrol plus gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer. This is a two stage study which consists of a safety run-in phase and a randomized phase II study which include patients with previously-untreated, metastatic pancreatic adenocarcinoma. In the run-in safety study, the safety of adding two formulations (IV or Oral) of paricalcitol to a standard chemotherapy program of gemcitabine and nab-paclitaxel will be evaluated. The randomized phase II study will evaluate the efficacy of paricalcitol when added to gemcitabine and nab-paclitaxel.
General Information
NCT#: NCT03520790
Study ID: 18-021
Trial Phase: Phase I/II
Trial Sponsor: SU2C - Stand Up to Cancer, Dana-Farber Cancer Institute, Lustgarten Foundation
Therapies Used in This Trial: Nab-paclitaxel, Gemcitabine, Paricalcitol