Cholesterol Disruption in Combination With FOLFIRINOX in Patients With Metastatic Pancreatic Adenocarcinoma

  • End date
    Jun 27, 2023
  • participants needed
  • sponsor
    CHU de Quebec-Universite Laval
Updated on 27 November 2021
measurable disease
pancreatic adenocarcinoma
cancer chemotherapy
pancreatic ductal adenocarcinoma
breast ductal carcinoma
metastatic pancreatic adenocarcinoma


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 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.

Condition Bone Metastases, metastasized, Neoplasm Metastasis, metastases, Digestive System Neoplasms, Cancer, Metastatic, secondary cancer, Metastasis, metastatic disease, cancer of the pancreas, Islet Ce417ll Cancer, Pancreatic Ductal Adenocarcinoma, Liver Metastases, pancreatic cancers, cancer, pancreatic, cancers metastatic, secondaries, Metastatic Cancer, Neoplasm of unspecified nature of digestive system, Brain Metastases, metastatic tumor, Pancreatic Cancer, Pancreatic Disorders, Pancreatic disorder
Treatment Cholesterol metabolism disruption
Clinical Study IdentifierNCT04862260
SponsorCHU de Quebec-Universite Laval
Last Modified on27 November 2021


Yes No Not Sure

Inclusion Criteria

To be eligible to this trial, patients must fulfill the following inclusion
Have a histologically confirmed, treatment-naive metastatic pancreatic ductal adenocarcinoma with liver metastases
Be at least 18 years or older at the time of signing the informed consent
Have a life expectancy of at least 12 weeks
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have measurable disease as assessed by RECIST v1.1
Agrees and amenable to a tumor and liver biopsy at baseline and on day 41 +/- 3 days. Patient that are anticoagulated at baseline are eligible provided it is deemed safe by the investigator to stop anticoagulation momentarily in order to safely proceed to a biopsy
Eligible to standard-dose FOLFIRINOX as assessed by the principal investigator or a sub-investigator
Demonstrate normal organ function as defined below. These assessments must be done within 7 days of Cycle 1 Day-7
Provide written informed consent and able to follow the trial treatment and visit schedule
For Women Of Child-Bearing Potential (WOCBP), a negative serum pregnancy test must be obtained prior to receiving the study medication
WOCBP should agree to use 2 different methods of birth control OR abstain from heterosexual intercourse for the duration of the trial and up to 90 days after the last study medication administration
Male subjects should agree to use an adequate method of contraception for the duration of the trial and up to 90 days after the last study medication administration. Male subjects should refrain from donating sperm during this period

Exclusion Criteria

To be eligible to this trial, patients must not fulfill any of the following
Known additional malignancy that is progressing or that requires treatment. Exceptions include basal cell carcinoma of the skin, in situ bladder or in situ cervical cancer. Other malignancy may be eligible after consultation with the chief investigator
Spinal cord compression or brain metastases unless treated, stable and not requiring steroids for at least 4 weeks prior to the initiation of study treatment
Baseline myalgia or myositis of any etiology
Prior treatment with FOLFIRINOX in the adjuvant setting
History of clinically significant intolerance or myositis with any statin
History of clinically significant intolerance or hypersensitivity to PCSK9 inhibitors or ezetimibe
Baseline grade 2 ULN Creatine Phosphokinase (CPK) elevation
Liver tumor burden that is deemed unsafe by the investigator
Major surgery or procedure from which the patient has not yet recovered
Any medical condition that puts the patient at high medical risk, including but not limited to active uncontrolled infection or active bleeding diathesis
Any history of disease that, in the opinion of the investigator, puts liver function at risk including but not limited to autoimmune hepatitis or history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Screening at baseline for those conditions is not required
Use of any drugs that are contraindicated as per protocol and that cannot be changed or modified to an acceptable alternative
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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