OncoMatch/Clinical Trials/NCT06736717
Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer
Is NCT06736717 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Onvansertib and NALIRIFOX for pancreatic cancer.
Treatment: Onvansertib · NALIRIFOX — Pancreatic cancer is a deadly disease and will be the second leading cause of cancer related death behind lung cancer by 2030. Over 62,000 people are diagnosed each year in the United States with about 90% succumbing to the disease within 5 years. In the metastatic setting, NALIRIFOX, FOLFIRINOX and nab-paclitaxel-gemcitabine are standard treatment options in patients with good performance status (Eastern Cooperative Oncology Group \[ECOG\] 0/1). All three combinations have shown a survival advantage over previously standard gemcitabine-based therapy, with 11.1 months overall survival (OS) for NALIRIFOX/FOLFIRINOX and 8.7 months for nab-paclitaxel-gemcitabine versus 6.7 months for gemcitabine alone. There is an urgent need to improve treatment of patients with current and emerging therapeutic strategies. KRAS is the most common oncogene mutated in pancreatic adenocarcinoma, and it is mutated in nearly all tumors. Mutant KRAS is essential for PDAC growth, where the constitutive activated RAS proteins contribute to tumorigenesis, treatment resistance, and metastases. Despite research and drug development efforts focused on KRAS, no effective RAS inhibitors have been approved for the treatment of pancreatic cancer with KRAS mutation. The poor prognosis of KRAS-mutated PDAC patients and the absence of KRAS-targeted therapies, highlight the urgency to develop novel therapies aimed at KRAS. This study will investigate onvansertib (also known as PCM-075 and NMS-1286937) as the first PLK1-specific adenosine triphosphate competitive inhibitor administered by oral route to enter clinical trials with proven antitumor activity in different preclinical models.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Leukocytes (WBC) > 3 K/UL; Absolute Neutrophil Count >1.5K/UL; Platelets >100K/UL; Hemoglobin 9 g/dL (level must be maintained without transfusions)
Kidney function
Calculated creatinine clearance 50 mL/min using the Cockcroft-Gault equation
Liver function
Total bilirubin 1.5 x ULN; AST and ALT 2.5 x ULN unless liver metastases are present, in which case they must be 5 x ULN
Cardiac function
QTcF 470 milliseconds; presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia
Adequate organ function, defined as follows: Leukocytes (WBC) > 3 K/UL; Absolute Neutrophil Count >1.5K/UL; Platelets >100K/UL; Hemoglobin 9 g/dL (level must be maintained without transfusions); Calculated creatinine clearance 50 mL/min using the Cockcroft-Gault equation; Total bilirubin 1.5 x ULN; AST and ALT 2.5 x ULN unless liver metastases are present, in which case they must be 5 x ULN; QTcF 470 milliseconds; presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Kansas Cancer Center, Westwood Campus · Kansas City, Kansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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