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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Ipspxmei Rlwxrnfjv Psy Ll Sjptir Dnn Teuvgt Dwqs Aqkmull Iwmv Snbyqc	Meldola	Italy
Ahrkwsk Ofwpergduaf Uwulrtoxgzkir Ojemxsis Rpwaohc	Foggia	Italy
Hrvtijkw Vanj dejwggeq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	14.06.2023
Spain	Recruiting	14.06.2023

Trial locations

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.

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 ID:

2024-518710-11-00

Protocol code:

VESPA

NCT ID:

NCT05821556

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?