This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.
Written informed consent to study procedures and to correlative studies.
Histologically or cytologically proven metastatic PDAC.
No prior treatments (chemotherapy, radiation or surgery) for PDAC
Either sex aged ≥ 18 years.
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.
Prior chemotherapy or any other medical treatment for metastatic PDAC (previous adjuvant chemotherapy is allowed if terminated > 6 months previously).
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.
Current use of statins or fibrates or any medication for hypercholesterolemia for any time during the 3 months before the study.
National Cancer Institute, Naples
Lead sponsor