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Cholesterol-Lowering Drug + Chemotherapy for Pancreatic Cancer
Study Summary
This trial will test whether adding a cholesterol-lowering drug to standard chemotherapy can improve outcomes in pancreatic cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have any uncontrolled infections or bleeding disorders.I quit smoking more than 3 months ago.You have had a bad reaction to PCSK9 inhibitors or ezetimibe in the past.I am 18 years old or older.My brain or spinal tumors are treated, stable, and I haven't needed steroids for 4 weeks.I am still recovering from a major surgery or procedure.My pancreatic cancer is advanced and cannot be removed by surgery.My doctor thinks my liver cancer is too advanced for some treatments.I am not on any medication that cannot be changed and is not allowed in the study.I am considered fit for standard-dose FOLFIRINOX chemotherapy.I have received FOLFIRINOX as a previous treatment.Your CPK level is higher than normal before starting the trial.Your doctor has found that you have a low amount of red blood cells.You have had a liver disease like hepatitis B, hepatitis C, HIV, or autoimmune hepatitis that could harm your liver function.You have had a bad reaction or muscle inflammation from taking any type of statin medication.I have another cancer, but it's not getting worse or needing treatment, except for certain skin, bladder, or cervical cancers.I experience muscle pain or inflammation.You have a disease that can be measured using specific guidelines.I agree to have a tumor and liver biopsy if it's safe, and I can pause my blood thinner for the biopsy.I am fully active or restricted in physically strenuous activity but can do light work.I can follow the trial's schedule and have given my written consent.My recent tests show my organs are functioning normally.I agree to use birth control during the trial and for 3 months after, and not to donate sperm.My pancreatic cancer is advanced but can be removed with surgery.My pancreatic cancer is considered operable or almost operable and can be treated with chemotherapy before surgery.
- Group 1: Multipathway cholesterol metabolism disruption
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What objectives are this experiment trying to accomplish?
"This trial seeks to evaluate safety by monitoring adverse events over a two year period. Secondary measurements of success include assessing changes in tumoral lipid droplet content using red oil staining, alterations of Low-density lipoprotein Receptor-Related Protein 1 levels evaluated with immunohistochemistry and modifications in Niemann-Pick C1-Like 1 protein concentration gauged via the same technique."
What is the participant count of this clinical investigation?
"Confirmed. Clinicaltrials.gov has this medical trial listed as actively recruiting candidates since its initial posting on November 4th 2021 and the last edit was made October 17th 2022. The study requires 12 participants to be enrolled at a single site."
Have prior research efforts investigated the ramifications of interrupting cholesterol homeostasis?
"Currently, 102 clinical trials examining Cholesterol metabolism disruption are active with 25 in Phase 3. Despite the concentration of research facilities located in Omaha, Nebraska; 1403 other clinics across America are also involved."
Is this experiment a pioneering endeavor?
"Global research into Cholesterol metabolism disruption has been ongoing since 2005, when Merck Sharp & Dohme LLC initiated their Phase 4 clinical trial with 80 participants. Since that time, a total of 650 trials have concluded and 102 are currently live in 354 cities across 45 countries."
What treatments commonly involve disruption of Cholesterol metabolism?
"Cholesterol metabolism disruption is generally implemented to address lipid related issues. It has also shown efficacy in treating a range of conditions such as lipidemias, postoperative thromboembolism, and anginal pain."
Are there any restrictions that would disqualify someone from enrolling in this research study?
"This experimental protocol is searching for 12 volunteers between the ages of 18 and 99 with adenocarcinoma. The enrollees must fulfill additional prerequisites, such as having a life expectancy longer than three months and demonstrating normal organ function within one week prior to treatment commencement. Furthermore, they should be able to provide written consent and comply with the trial's visit schedule. Lastly, those selected for this study need to meet other criteria related to their hemoglobin levels, platelet count, creatinine levels, bilirubin readings and more which are outlined in detail in these instructions"
Is there still opportunity to participate in this experiment?
"Clinicaltrials.gov documents this medical trial is still seeking participants, after its initial posting on November 4th 2021 and most recent update October 17th 2022."
Does this trial's eligibility extend to octogenarians?
"This clinical trial is enrolling participants aged 18 to 99. Additionally, there are 40 trials open for minors and 1626 studies available for senior citizens."
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