Study on Onvansertib and NALIRIFOX for First-Line Treatment of Advanced Pancreatic Cancer

Sponsor: University of Kansas Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT06736717

Provider View

This clinical trial is exploring a new treatment combination of Onvansertib and NALIRIFOX for patients with advanced pancreatic cancer. The study aims to improve outcomes for patients with this aggressive cancer type.

Patient Parameters

Program Overview

Pancreatic cancer is a serious disease and is expected to become the second leading cause of cancer-related deaths by 2030. Each year, over 62,000 people in the U.S. are diagnosed, and about 90% do not survive beyond five years. Current treatments like NALIRIFOX, FOLFIRINOX, and nab-paclitaxel-gemcitabine have shown some improvement in survival rates, but there is a need for better options. This study focuses on a new drug, Onvansertib, which targets a common mutation in pancreatic cancer called KRAS. The goal is to see if Onvansertib, combined with NALIRIFOX, can offer better results for patients with advanced pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and be willing to sign a consent form.
  • Men and women aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Have measurable cancer as defined by specific medical criteria.
  • Diagnosed with adenocarcinoma of the pancreas that cannot be removed by surgery or has spread.
  • Have not received previous treatment for cancer that has spread.
  • Willing to provide a previous tumor sample or undergo a new biopsy if safe.
  • Have adequate organ function, including:
    • White blood cell count above 3 K/UL
    • Neutrophil count above 1.5 K/UL
    • Platelet count above 100 K/UL
    • Hemoglobin level of at least 9 g/dL without transfusions
    • Kidney function with creatinine clearance of at least 50 mL/min
    • Total bilirubin level within 1.5 times the normal limit
  • Liver enzymes within specific limits unless liver metastases are present.
  • Women and men with partners who can become pregnant must agree to use effective birth control methods.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Planning to use other cancer treatments during the study.
  • Have a psychiatric condition or social situation that would prevent following the study requirements.
  • Pregnant or breastfeeding.
  • Allergic to any ingredients in the study drug.
  • Have a severe infection within two weeks before starting the study.
  • Had major surgery within four weeks before joining the study.
  • Have untreated or symptomatic brain cancer spread.
  • Have a digestive disorder that affects the absorption of oral medication.
  • Unable or unwilling to take the study drug by mouth.
  • Have uncontrolled health issues, such as heart failure or severe lung disease.
  • Have active infections like HIV or hepatitis B or C.
  • Have a history of other cancers, except for certain treated skin or cervical cancers.
  • Have any condition that makes the study treatment unsafe.
  • Taking medications that affect heart rhythm or interact with the study drug.
  • Have a prolonged QT interval on an ECG test.

Locations

FACILITYZIPCITYSTATE
The University of Kansas Cancer Center, Westwood Campus66205Kansas CityKansas

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