OncoMatch/Clinical Trials/NCT05821556
Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients
Is NCT05821556 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for adenocarcinoma of the pancreas.
Treatment: Valproic acid · Simvastatin 20mg · Gemcitabine 1000 mg · Nab paclitaxel · Cisplatin · Capecitabine — This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: DPYD activity known
Known dihydropyrimidine dehydrogenase (DPD) activity is mandatory for patients enrolled in PAXG scheme
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: previous adjuvant chemotherapy is allowed if terminated > 6 months previously
No prior treatments (chemotherapy, radiation or surgery) for PDAC; Prior chemotherapy or any other medical treatment for metastatic PDAC (previous adjuvant chemotherapy is allowed if terminated > 6 months previously)
Cannot have received: HDAC inhibitor (valproic acid)
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
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L AND platelet count ≥ 100 x 10^9/L AND haemoglobin ≥ 9 g/dL
Kidney function
serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (Cockroft-Gault)
Liver function
total bilirubin ≤ 1.5 x ULN or ≤ 2 in case of biliary stent; AST/ALT ≤ 5 X ULN
Adequate bone marrow haematological function: absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L AND platelet count ≥ 100 x 10^9/L AND haemoglobin ≥ 9 g/dL. Adequate liver function: total bilirubin ≤ 1.5 x ULN or ≤ 2 in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN. Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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