Clinical trialPhase 2Recruiting
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).
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 12 June 2023
- Expected end
- June 2027
- Enrollment
- 240 participants
- Sites
- 5
- Primary outcomes
- Progression Free Survival (PFS)
- Sponsor
- Other
- Results posted
- No
- Last update
- 14 April 2026
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Brief summary public domain (ClinicalTrials.gov)
This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.
Detailed description public domain (ClinicalTrials.gov)
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.