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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05821556
Study type Interventional
Source National Cancer Institute, Naples
Contact Antonio Avallone
Phone 08117770357
Email a.avallone@istitutotumori.na.it
Status Recruiting
Phase Phase 2
Start date June 12, 2023
Completion date June 2026

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