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Cholesterol Metabolism Disruptor

Cholesterol-Lowering Drug + Chemotherapy for Pancreatic Cancer

Phase < 1

Waitlist Available

Led By Francine Aubin, MD FRCPC

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be at least 18 years or older at the time of signing the informed consent

Have a histologically confirmed, treatment-naive locally advanced and inoperable (LaiPDAC) or metastatic pancreatic ductal adenocarcinoma (mPDAC)

Must not have

Any medical condition that puts the patient at high medical risk, including but not limited to active uncontrolled infection or active bleeding diathesis

Major surgery or procedure from which the patient has not yet recovered

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether adding a cholesterol-lowering drug to standard chemotherapy can improve outcomes in pancreatic cancer.

Who is the study for?

This trial is for adults with newly diagnosed, untreated advanced pancreatic cancer that can't be removed by surgery or has spread. They must have a life expectancy of at least 12 weeks, good performance status (able to carry out daily activities), and normal organ function. Women who can bear children and men must use effective birth control during the study.

What is being tested?

The study tests if adding cholesterol-lowering drugs (atorvastatin, ezetimibe, Repatha) to standard chemotherapy (FOLFIRINOX) slows down or stops pancreatic cancer progression. It's a proof-of-concept trial aiming to see if this combination is feasible and acceptable for patients.

What are the potential side effects?

Possible side effects include muscle pain or weakness due to statins, allergic reactions to any of the drugs used in the trial, liver-related issues from biopsies or drug interactions, and general chemotherapy side effects like fatigue, nausea, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My pancreatic cancer is advanced and cannot be removed by surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled infections or bleeding disorders.

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I am still recovering from a major surgery or procedure.

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I am not on any medication that cannot be changed and is not allowed in the study.

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I have received FOLFIRINOX as a previous treatment.

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I experience muscle pain or inflammation.

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My pancreatic cancer is advanced but can be removed with surgery.

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My pancreatic cancer is considered operable or almost operable and can be treated with chemotherapy before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Characterization of dose-limiting toxicities

Safety as measured by the rate of adverse events

Secondary study objectives

CD36 (Cluster of Differentiation 36) changes in response to the multipathway cholesterol embargo

Change in tumoral and hepatic levels of TILs (Tumor-Infiltrating Lymphocytes)

LDLR (low-density lipoprotein receptor) tumoral and hepatic changes in response to the multipathway cholesterol embargo.

+5 more

Other study objectives

Efficacy as measured by objective response rate

Efficacy as measured by overall survival

Efficacy as measured by progression free survival

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Multipathway cholesterol metabolism disruptionExperimental Treatment1 Intervention

Twelve to fifteen patients will receive a combination of daily atorvastatin 40 mg, twice daily ezetimibe 10 mg and evolocumab 420 mg subcutaneously every month. This multipathway cholesterol metabolism disruption will be combined to standard chemotherapy (FOLFIRINOX).

0 / 10Eligibility criteria met