Cholesterol-Lowering Drug + Chemotherapy for Pancreatic Cancer

Not currently recruiting at 2 trial locations

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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lowering cholesterol can enhance the effectiveness of chemotherapy in fighting pancreatic cancer. It combines three cholesterol-lowering drugs with standard chemotherapy to determine if this approach slows or stops cancer growth. The trial seeks participants recently diagnosed with locally advanced or metastatic pancreatic cancer that cannot be surgically removed. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking therapy.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using the cholesterol-lowering drugs atorvastatin, ezetimibe, and evolocumab (also known as Repatha) together is generally safe and well-tolerated over long periods. Studies have found that these drugs can be combined without major problems. In everyday use, evolocumab has been widely used, and reports of serious side effects are rare.

Atorvastatin and ezetimibe are well-known for lowering cholesterol levels and are usually well-tolerated, with mild side effects like muscle pain or digestive issues being the most common. Evolocumab is a newer drug that also lowers cholesterol but works differently. It is given as a monthly injection.

This combination of drugs is already used to manage cholesterol and protect against heart disease. Researchers are now exploring whether it can help fight pancreatic cancer by depriving cancer cells of cholesterol, potentially slowing or stopping their growth. Although this research is in the early stages, the safety record of these drugs in other uses suggests promising tolerance in this new area.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about this treatment because it targets cholesterol metabolism to enhance the effectiveness of chemotherapy for pancreatic cancer. Unlike standard treatments that focus solely on chemotherapy, this approach combines cholesterol-lowering drugs like atorvastatin, ezetimibe, and evolocumab with chemotherapy (FOLFIRINOX). The unique mechanism of disrupting cholesterol pathways may improve the delivery and impact of chemotherapy on cancer cells, offering hope for better outcomes in a notoriously difficult-to-treat cancer.

What evidence suggests that this cholesterol metabolism disruption is effective for pancreatic cancer?

Research has shown that interfering with cholesterol function in the body can slow pancreatic cancer cell growth and increase their responsiveness to chemotherapy. Cholesterol plays a crucial role in the growth and spread of cancer cells, particularly in pancreatic cancer. In this trial, participants will receive a combination of medications—atorvastatin, ezetimibe, and evolocumab—designed to significantly lower cholesterol levels. This treatment aims to deprive cancer cells of the cholesterol they need, slowing their growth and enhancing the effects of standard chemotherapy. This approach is expected to improve pancreatic cancer management by weakening cancer cells and making them more vulnerable.¹ ³ ⁴ ⁶ ⁷