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

NCT03883919 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-10-05

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Kian-Huat Lim, M.D, Ph.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2021-03-23
Completion
2022-07-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883919 on ClinicalTrials.gov