Actively Recruiting
Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients
Led by National Cancer Institute, Naples · Updated on 2026-04-14
240
Participants Needed
5
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.
CONDITIONS
Official Title
Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for study procedures and correlative studies
- Have metastatic pancreatic ductal adenocarcinoma confirmed by histology or cytology
- Have not received any prior chemotherapy, radiation, or surgery for pancreatic cancer
- Be 18 years of age or older, any gender
- Have an ECOG Performance Status of 0 or 1 at study entry
- Have measurable disease by imaging according to RECIST 1.1 criteria
- Known dihydropyrimidine dehydrogenase (DPD) activity for patients in the PAXG treatment group
- Have adequate bone marrow function with ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, and hemoglobin ≥ 9 g/dL
- Have adequate liver function with total bilirubin ≤ 1.5 x ULN (or ≤ 2 if biliary stent present) and AST/ALT ≤ 5 x ULN
- Have adequate kidney function with serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min (males) or ≥ 50 mL/min (females)
You will not qualify if you...
- History of another cancer within the past year, except treated basal or squamous cell skin cancer or in situ cervical cancer
- Prior chemotherapy or other medical treatment for metastatic pancreatic cancer (prior adjuvant chemotherapy allowed if ended > 6 months ago)
- Previous treatment with HDAC inhibitors or drugs with similar activity like valproic acid
- Use of statins, fibrates, or cholesterol medications within 3 months before study start
- Known allergy to statins or any study medication components
- Major surgery within 4 weeks before enrollment
- Pregnancy or breastfeeding
- Presence of brain metastases
- Hepatitis or severe liver disorders
- Severe or uncontrolled systemic diseases or other conditions that could interfere with study participation or compliance
- Long QT syndrome or QTc interval > 480 msec or use of medications that prolong QTc
- Poor cooperation, non-compliance, or inability to understand informed consent
- Participation in another drug or device study within 30 days before treatment
- Inability to take oral medication, need for intravenous nutrition, prior surgeries affecting absorption, or active peptic ulcer disease
- Sexually active individuals of childbearing potential unwilling to use contraception during and for 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
Naples, Italy, Italy, 80131
Actively Recruiting
2
Università vita e Salute, IRCCS San Raffaele
Milan, Milano, Italy
Actively Recruiting
3
Università Cattolica Del Sacro Cuore, IRCCS Fondazione Policlinico Universitario Gemelli - Medical Oncology, Roma, Italia
Roma, Roma, Italy
Actively Recruiting
4
University of Verona Hospital Trust
Verona, Verona, Italy, 37122
Actively Recruiting
5
Ramon y Cajal Hospital and Health Research Institute (IRYCIS)
Madrid, Madrid, Spain
Actively Recruiting
Research Team
A
Antonio Avallone
CONTACT
A
Alessandra Leone
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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