Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma

Summary

Cardiovascular diseases and cancers, the two leading causes of death in Canada, require cholesterol to sustain their progression. All cells require cholesterol, but cancer cells have much higher needs to sustain growth, division and metastasis. The availability of new cholesterol-lowering drugs developed to protect patients from heart diseases has resulted in unprecedented low levels of cholesterol. The combination of atorvastatin, ezetimibe and Repatha, which are 3 cholesterol-lowering drugs used in combination, is safe, well tolerated and efficient over years of treatment. Recent reports indicate that abundant cholesterol supplies are required to sustain the progression of pancreatic ductal adenocarcinomas. This proof-of-concept study aims to verify the feasibility, the acceptability and gain preliminary data on adding a cholesterol shortage on top of FOLFIRINOX (standard chemotherapy) in newly diagnosed patients with locally advanced pancreatic adenocarcinomas or metastatic pancreatic adenocarcinomas. It is expected that a drug-induced cholesterol shortage will slow-down or stop the progression of pancreatic adenocarcinomas while increasing the response to chemotherapy.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Pancreatic Cancer
• Pancreas Cancer
• Metastatic Cancer

Interventions

DRUG

Cholesterol metabolism disruption

Cholesterol metabolism disruption using a combination of atorvastatin, ezetimibe and evolocumab in metastatic pancreatic adenocarcinomas

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Biovalorem

  collaborator UNKNOWN

• CHU de Quebec-Universite Laval

  lead OTHER

Principal Investigators

• Anne Gangloff, MD PhD FRCPC · CHU de Québec-Université Laval

• Maxime Chénard-Poirier, MD FRCPC · CHU de Québec-Université Laval

• Félix Couture, MD FRCPC · CHU de Québec-Université Laval

• Vincent Castonguay, MD FRCPC · CHU de Québec-Université Laval

• Olivier Dumas, MD FRCPC · CHU de Québec-Université Laval

• Anne-Marie Carreau, MD FRCPC · CHU de Québec-Université Laval

• Frédéric Calon, PhD · CHU de Québec-Université Laval

• Nabil G. Seidah, PhD · Institut de recherches cliniques de Montréal

• Francine Aubin, MD FRCPC · CHUM

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-04

Primary Completion

2025-01-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• Canada

Study Locations