Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients
Randomized Phase 2 Study of Valproic Acid combinEd With Simvastatin and Gemcitabine/Nab-paclitaxel-based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (The VESPA Trial).
Sponsor: National Cancer Institute, Naples
Listed as NCT05821556, this observational or N/A phase trial focuses on Adenocarcinoma of the Pancreas and remains actively recruiting participants. Sponsored by National Cancer Institute, Naples, it has been updated 8 times since 2023, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Apr 16, 2026 — Present [daily]
Recruiting
Phase: PHASE2 → None
-
Sep 2025 — Apr 2026 [monthly]
Recruiting PHASE2
-
Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE2
-
Sep 2024 — Aug 2025 [monthly]
Recruiting PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE2
▶ Show 3 earlier versions
-
Jul 2023 — Jul 2024 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
-
Jun 2023 — Jul 2023 [monthly]
Not Yet Recruiting PHASE2
-
May 2023 — Jun 2023 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.
Contact Information
- National Cancer Institute, Naples
For direct contact, visit the study record on ClinicalTrials.gov .