Liposomal Irinotecan Plus 5-FU / LV Combined With Paricalcitol in Patients With Advanced Pancreatic Cancer Progressed on Gemcitabine-based Therapy

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 11, 2019

Primary Completion Date

March 23, 2021

Study Completion Date

July 2, 2022

Conditions
Pancreatic CancerPancreas CancerCancer of the Pancreas
Interventions
DRUG

5-FU

-Standard of care drug

DRUG

Leucovorin

-Standard of care drug

DRUG

Liposomal Irinotecan

-Standard of care drug

DRUG

Paricalcitol

-Investigational drug

PROCEDURE

Serum and plasma blood samples

-baseline, day 1 of each cycle beginning with cycle 2

PROCEDURE

Tumor biopsy

"* 5 patients in each arm will be required to undergo a mandatory tumor biopsy from the primary pancreatic site or metastatic site, if safe and feasible, prior to cycle 1~* After Cycle 3 of treatment, all patients who had a baseline biopsy will be required to undergo a mandatory biopsy of the same site if safe and feasible."

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ipsen

INDUSTRY

lead

Washington University School of Medicine

OTHER