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Pressure Enabled Drug Delivery By Pancreatic Retrograde Venous Infusion For Advanced Pancreatic Carcinoma

NCT04270929 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-06-01

No results posted yet for this study

Summary

This is an open label, single institution, dose-escalation phase 1 study designed to assess the feasibility, safety, and efficacy of oxaliplatin administered via Pancreatic Retrograde Venous Infusion (PRVI) using Pressure Enabled Drug Delivery (PEDD) technology. Oxaliplatin PEDD-PRVI is administered with systemic FOLFIRI followed by FOLFIRINOX therapy for the treatment of patients with unresectable or metastatic pancreatic adenocarcinoma.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

DRUG

FOLFIRI

During Cycles 1 and 2, standard of care systemic FOLFIRI will be delivered on Days 2-4 following oxaliplatin PEDD-PRVI.

DRUG

FOLFIRINOX

During Cycles 3-6, standard of care systemic FOLFIRINOX will be administered on Days 1-3.

DEVICE

TriSalus Infusion System

The TriSalus Infusion System administers therapeutics using PEDD technology.

Sponsors & Collaborators

  • TriSalus Life Sciences, Inc.

    collaborator INDUSTRY

  • Roger Williams Medical Center

    lead OTHER

Principal Investigators

  • Rathore · Roger Williams Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2021-05-04
Completion
2021-05-04
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04270929 on ClinicalTrials.gov