Cholesterol-Lowering Drug + Chemotherapy for Pancreatic Cancer

Recruiting at 1 trial location

Overseen ByAnne Gangloff, MD PhD FRCPC

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: CHU de Quebec-Universite Laval

Must be taking: Cholesterol-lowering drugs

Must not be taking: Statins, PCSK9 inhibitors

Disqualifiers: Operable cancer, Other malignancy, Myalgia, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, it mentions that any drugs contraindicated by the protocol that cannot be changed or modified to an acceptable alternative would exclude you from participation. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the cholesterol metabolism disruption treatment for pancreatic cancer?

Research shows that disrupting cholesterol metabolism can slow the growth of pancreatic cancer cells and make them more sensitive to chemotherapy. Studies found that reducing cholesterol in cancer cells can decrease tumor growth and improve the effectiveness of chemotherapy drugs.¹ ² ³ ⁴ ⁵

Is the combination of cholesterol-lowering drugs and chemotherapy safe for humans?

The research suggests that targeting cholesterol metabolism, such as using avasimibe, in combination with chemotherapy, has been studied for pancreatic cancer and shows potential in reducing tumor growth. However, specific safety data for humans is not detailed in these studies, so it's important to consult with healthcare providers for personalized advice.¹ ² ³ ⁴ ⁵

How does the cholesterol-lowering drug combined with chemotherapy work for pancreatic cancer?

This treatment is unique because it targets cholesterol metabolism in pancreatic cancer cells, which are highly dependent on cholesterol for growth and survival. By disrupting cholesterol uptake and synthesis, the treatment reduces tumor growth and enhances the effectiveness of chemotherapy, offering a novel approach compared to traditional treatments that do not focus on cholesterol metabolism.² ³ ⁴ ⁵ ⁶

What is the purpose of this trial?

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.