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

Phase 2 Recruiting 240 enrolled National Cancer Institute, Naples

RandomizedParallel-groupOpen-labelTreatment

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

Evaluation	Drug	Modality	Dose	Route
Subject	Simvastatin	Small molecule	20 mg	Oral
Subject	Valproic Acid	Small molecule	—	Oral
Background	Capecitabine	Small molecule	1250 mg/m2	Oral
Background	Cisplatin	Other / unclassified	30 mg/m2	—
Background	Gemcitabine	Small molecule	800 mg/m2	—
Background	Gemcitabine	Small molecule	1000 mg/m2	—
Background	Paclitaxel	Small molecule	125 mg/m2	—
Background	Paclitaxel	Small molecule	150 mg/m2	—