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Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients

Randomized Phase 2 Study of Valproic Acid combinEd With Simvastatin and Gemcitabine/Nab-paclitaxel-based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (The VESPA Trial).

NCT05821556•National Cancer Institute, Naples

View on ClinicalTrials.gov

Summary

This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.

Detailed Description

The study hypothesizes that valproic acid (VPA) in combination with simvastatin (SIM) may improve the efficacy of first-line gemcitabine and nab-paclitaxel-based regimens and extend progression free survival (PFS) as compared with chemotherapy alone, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Correlative studies on tumor and blood samples could identify potential biomarkers of toxicity and efficacy helping to define personalized treatment strategy and adding new insight into the antitumor mechanism of the combination approach.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent to study procedures and to correlative studies.
•2. Histologically or cytologically proven metastatic PDAC.
•3. No prior treatments (chemotherapy, radiation or surgery) for PDAC
•4. Either sex aged ≥ 18 years.
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 at study entry.
•6. Imaging-documented measurable disease, according to RECIST 1.1 criteria.
•7. Known dihydropyrimidine dehydrogenase (DPD) activity is mandatory for patients enrolled in PAXG scheme.
•8. Adequate bone marrow haematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L AND platelet count ≥ 100 x 109/L AND haemoglobin ≥ 9 g/dL.
•9. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN.
•10. Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula).

Exclusion Criteria

•1. Prior malignancy within one year. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
•2. Prior chemotherapy or any other medical treatment for metastatic PDAC (previous adjuvant chemotherapy is allowed if terminated \> 6 months previously).
•3. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.
•4. Current use of statins or fibrates or any medication for hypercholesterolemia for any time during the 3 months before the study.
•5. Proven hypersensitivity to statins and to any component of the other medications used in the trial.
•6. Major surgical intervention within 4 weeks prior to enrollment;
•7. Pregnancy and breast-feeding.
•8. Brain metastasis.
•9. Hepatitis or any severe liver disorder.
•10. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.
+5 more criteria

Locations (5)

Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale

Naples, Italy, Italy

Università vita e Salute, IRCCS San Raffaele

Milan, Milano, Italy

Università Cattolica Del Sacro Cuore, IRCCS Fondazione Policlinico Universitario Gemelli - Medical Oncology, Roma, Italia

Roma, Roma, Italy

University of Verona Hospital Trust

Verona, Verona, Italy

Ramon y Cajal Hospital and Health Research Institute (IRYCIS)

Madrid, Madrid, Spain

Key Dates

Start Date

June 12, 2023

Primary Completion Date

August 1, 2025

Completion Date

June 1, 2026

Last Updated

July 29, 2025

Enrollment

240

ESTIMATED participants

Conditions

Adenocarcinoma of the Pancreas

Interventions

Valproic acid

DRUG

Simvastatin 20mg

DRUG

Gemcitabine 1000 mg

DRUG

Nab paclitaxel

DRUG

Cisplatin

DRUG

Capecitabine

DRUG

Contacts

Antonio Avallone

CONTACT

08117770357 a.avallone@istitutotumori.na.it

Alessandra Leone

CONTACT

08117770585 a.leone@istitutotumori.na.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients

Inclusion Criteria

Exclusion Criteria

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