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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Valproic acid
  • Simvastatin 20mg
  • Gemcitabine 1000 mg
  • Nab paclitaxel
  • Cisplatin
  • Capecitabine

Treatment groups

240 Participants
are divided into 2 treatment groups