Onvansertib in Combination With NALIRIFOX for First Line Treatment of Advanced Pancreatic Cancer

Exclusion Criteria

• •Simultaneously enrolled in any therapeutic clinical trial
• •Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
• •Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• •Is pregnant or breastfeeding
• •Has a known allergic reaction to any excipient contained in the study drug formulation
• •Active Grade 3 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.027) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
• •Patient has had major surgery within 4 weeks prior to enrollment
• •Untreated or symptomatic brain metastasis
• •Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (e.g., intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
• •Unable or unwilling to swallow study drug
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure (CHF) Class II or higher according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection
• •Known active infection with HIV, with measurable viral titer, and/or active infection with hepatitis B or C (patients who have had a hepatitis B virus immunization are eligible)
• •Known active infection with SARS-CoV-2 where symptoms are present
• •Clinically significant ascites or pleural effusions
• •Patients with a history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or prostate, or other solid tumors curatively treated with no evidence of disease for \> 2 years
• •Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug per PI discretion.
• •Any condition (e.g., psychological, geographical, etc.) that does not permit compliance with the protocol
• •Treatment with any of the drugs listed in section with title; Prohibited or Restricted Concomitant Medications at the time of study treatment initiation. Planned concomitant use of medications known to prolong the QT/QTc interval according to institutional guidelines. Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers. Patients currently receiving these agents who can be switched to alternate therapy are not excluded. Inhibitors should be stopped at least 1 week prior to the first dose of protocol therapy and inducers should be stopped at least 2 weeks prior to initiation of protocol therapy
• •QT interval: Fridericia's correction (QTcF) \> 470 milliseconds.
• •* A single ECG is sufficient. Triplicate may be done per PI discretion. If triplicate ECG completed, the QTcF should be calculated as the arithmetic mean of the QTcF on triplicate ECGs. In the case of potentially correctible causes of QT prolongation that are readily corrected (e.g., medications, hypokalemia), the triplicate ECG may be repeated once during Screening and that result may be used to determine eligibility
• •* Presence of risk factors for torsade de pointes, including family history of Long QT Syndrome or uncorrected hypokalemia