Could two old drugs boost chemo for pancreatic cancer?
NCT ID NCT05821556
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding valproic acid and simvastatin to standard chemotherapy can help people with untreated metastatic pancreatic cancer live longer without their disease getting worse. About 240 participants will be randomly assigned to receive either the standard chemo alone or the standard chemo plus the two extra drugs. The study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- valproic acid and simvastatin combined with gemcitabine/nab-paclitaxel chemotherapy
- What this could lead to
- If it works, this could point toward a more effective first-line treatment for metastatic pancreatic cancer, potentially slowing disease progression.
- What could go wrong
- This is an early phase 2 trial with a small sample size. The added drugs may not improve outcomes and could increase side effects. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 11. Patients with long QT-syndrome or QTc interval duration \> 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix). 12. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form. 13. Participation in any interventional drug or medical device study within 30 days prior to treatment start. 14. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. 15. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study and until 6 months after the last trial treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale
RECRUITINGNaples, Italy, 80131, Italy
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Ramon y Cajal Hospital and Health Research Institute (IRYCIS)
RECRUITINGMadrid, Madrid, Spain
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University of Verona Hospital Trust
RECRUITINGVerona, Verona, 37122, Italy
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Università Cattolica Del Sacro Cuore, IRCCS Fondazione Policlinico Universitario Gemelli - Medical Oncology, Roma, Italia
RECRUITINGRoma, Roma, Italy
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Università vita e Salute, IRCCS San Raffaele
RECRUITINGMilan, Milano, Italy
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