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Study on Valproic Acid, Simvastatin, and Gemcitabine for Untreated Metastatic Pancreatic Cancer Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called metastatic pancreatic ductal adenocarcinoma, which is a form of pancreatic cancer that has spread to other parts of the body. The study is testing a combination of medications to see if they can improve treatment outcomes for patients who have not yet received any treatment for this cancer. The medications being tested include valproic acid, simvastatin, gemcitabine, and nab-paclitaxel. Valproic acid is commonly used to treat seizures, simvastatin is used to lower cholesterol, gemcitabine is a chemotherapy drug, and nab-paclitaxel is a form of chemotherapy that uses a protein to help deliver the drug to cancer cells.

The purpose of the study is to determine if the combination of these medications can improve the effectiveness of the standard treatment, which includes gemcitabine and nab-paclitaxel. Participants in the study will be randomly assigned to receive either the standard treatment or the new combination of medications. The study will monitor how long patients live without the cancer getting worse, as well as other factors like tumor response, overall survival, and quality of life. Blood samples will also be collected to study how the body processes the drugs and to look for markers that might predict how well the treatment works or what side effects might occur.

The study will take place over several months, with regular check-ups and assessments to track the progress of the disease and the effects of the treatment. The goal is to find a more effective treatment option for patients with metastatic pancreatic ductal adenocarcinoma, potentially improving their quality of life and survival rates. Participants will receive either the new combination of medications or the standard treatment, and their health will be closely monitored throughout the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of the treatment groups. This is a randomized phase 2 study focusing on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

  2. Step 2

    Treatment initiation

    The treatment involves a combination of medications. The patient will receive paclitaxel albumin-bound and gemcitabine through infusion. These medications are administered to target cancer cells.

    Additionally, the patient will take valproic acid and simvastatin orally. These medications are intended to enhance the effectiveness of the treatment regimen.

  3. Step 3

    Medication schedule

    The infusion of paclitaxel albumin-bound and gemcitabine will be scheduled according to the study protocol. The exact frequency and duration will be communicated by the healthcare team.

    Oral medications, valproic acid and simvastatin, will be taken daily. The specific dosage will be determined based on individual patient needs and study guidelines.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular monitoring will occur to assess the patient's response to treatment. This includes imaging tests to evaluate tumor size and progression.

    Blood samples will be collected to evaluate pharmacokinetic and pharmacodynamic biomarkers, which help understand how the body processes the medications.

  5. Step 5

    Evaluation of outcomes

    The primary outcome of the study is progression-free survival, which measures the time until the disease progresses or the patient experiences any cause of death.

    Secondary outcomes include tumor response rate, disease control rate, overall survival, and quality of life assessments.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by December 31, 2026. Upon completion, the results will be analyzed to determine the effectiveness of the treatment regimen.

Who can join the trial?

10 criteria

  • You must provide a signed agreement to participate in the study and related research.
  • You need to have a confirmed diagnosis of **metastatic pancreatic ductal adenocarcinoma (mPDAC)**, which means the cancer has spread from the pancreas to other parts of the body.
  • You should not have received any previous treatments like chemotherapy, radiation, or surgery for mPDAC.
  • Your **Eastern Cooperative Oncology Group (ECOG) Performance Status** should be 0 or 1, which indicates you are fully active or have some symptoms but can still carry out light work.
  • You must have a disease that can be measured through imaging tests, following specific guidelines called **RECIST 1.1 criteria**.
  • You must be 18 years of age or older, regardless of gender.
  • If you are part of the PAXG treatment group, your **dihydropyrimidine dehydrogenase (DPD) activity** must be known. This is an enzyme that helps break down certain drugs in the body.
  • Your bone marrow must be functioning well, with specific levels of blood cells: **absolute neutrophil count** of at least 1.5 x 109/L, **platelet count** of at least 100 x 109/L, and **hemoglobin** of at least 9 g/dL.
  • Your liver function should be adequate, with **total bilirubin** levels at or below 1.5 times the normal limit (or 2 times if you have a biliary stent), and **aspartate aminotransferase (AST)** and **alanine aminotransferase (ALT)** levels at or below 5 times the normal limit.
  • Your kidney function should be adequate, with **serum creatinine** at or below 1.5 mg/dL, or **creatinine clearance** of at least 60 mL/min for males and 50 mL/min for females, which is a measure of how well your kidneys are filtering blood.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than metastatic pancreatic ductal adenocarcinoma (mPDAC). This is a specific type of cancer that starts in the pancreas and has spread to other parts of the body.
  • Patients who are not within the specified age range for the study. The study is looking for participants within certain age groups.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
  • Patients who are participating in another clinical trial at the same time, as this could affect the results of the study.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who have allergies or reactions to the study medications or similar drugs.
  • Patients who have a history of drug or alcohol abuse, which might affect their ability to follow the study requirements.
  • Patients who have certain infections or diseases that could interfere with the study or pose a risk to other participants.
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Investigated drugs

  • Valproic Acid

    is a medication that is being tested in combination with other drugs to see if it can improve treatment outcomes for patients with metastatic pancreatic cancer. It is commonly used to treat seizures and mood disorders, but in this trial, it is being explored for its potential to enhance cancer treatment.

  • Simvastatin

    is a drug typically used to lower cholesterol levels in the blood. In this trial, it is being combined with other medications to investigate if it can help improve the effectiveness of cancer treatment for patients with metastatic pancreatic cancer.

  • Gemcitabine

    is a chemotherapy medication used to treat various types of cancer, including pancreatic cancer. It works by slowing or stopping the growth of cancer cells. In this trial, it is part of the treatment regimen being tested for its effectiveness in combination with other drugs.

  • Nab-Paclitaxel

    is another chemotherapy drug used to treat different cancers, including pancreatic cancer. It is a form of paclitaxel that is bound to a protein called albumin, which helps deliver the drug to the cancer cells more effectively. In this study, it is used alongside other medications to evaluate its role in treating metastatic pancreatic cancer.

What is already known about the treatment

  • Valproic Acid

    This medication is administered orally and is currently being studied in combination with other drugs for its potential benefits in treating metastatic pancreatic ductal adenocarcinoma. It is primarily used as an anticonvulsant and mood stabilizer, but in this trial, it is being evaluated for its ability to enhance the effectiveness of cancer treatment regimens. Valproic acid works by increasing the levels of certain neurotransmitters in the brain and may also affect cancer cells by altering gene expression. It belongs to the pharmacological class of fatty acid derivatives.

  • Simvastatin

    Administered orally, simvastatin is commonly used to lower cholesterol levels but is being investigated for its potential role in cancer treatment. In the context of this trial, it is combined with other medications to assess its impact on metastatic pancreatic ductal adenocarcinoma. Simvastatin works by inhibiting an enzyme involved in cholesterol synthesis, which may also interfere with cancer cell growth. It is classified as a statin, a type of lipid-lowering agent.

  • Gemcitabine

    This medication is given intravenously and is a standard chemotherapy drug used to treat various cancers, including pancreatic cancer. In this trial, it is part of a combination regimen aimed at improving outcomes for patients with metastatic pancreatic ductal adenocarcinoma. Gemcitabine works by interfering with DNA synthesis, thereby preventing cancer cells from multiplying. It is classified as an antimetabolite.

  • Nab-Paclitaxel

    Administered intravenously, nab-paclitaxel is a chemotherapy drug used in combination with other treatments for certain types of cancer, including pancreatic cancer. In this study, it is used alongside other medications to evaluate its effectiveness in treating metastatic pancreatic ductal adenocarcinoma. Nab-paclitaxel works by stabilizing microtubules, which disrupts cell division and leads to cancer cell death. It is part of the taxane class of chemotherapy agents.

Investigated diseases

Metastatic Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas and has spread to other parts of the body. It is characterized by the uncontrolled growth of cells in the pancreatic ducts, which can invade nearby tissues and organs. As the disease progresses, it can cause symptoms such as abdominal pain, weight loss, and jaundice. The spread of cancer cells to distant organs, known as metastasis, often complicates the condition. This disease is typically aggressive, with cancer cells rapidly dividing and forming new tumors in other areas. The progression of the disease can vary, but it often involves the liver, lungs, and peritoneum.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518710-11-00Protocol codeVESPAEstimated enrolment170 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

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