The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer

Inclusion criteria

• Participants must have histological or cytological confirmed pancreatic adenocarcinoma malignancy that is metastatic (including recurrent with distant metastases) or locally advanced.
• Receiving first line chemotherapy (within 45 days of first dose of study drug) Note: subjects must be either initiating first systemic cancer therapy regimen following initial diagnosis or initiating first cycle of chemotherapy for disease recurrence.
• Minimum age 18 years.
• Life expectancy of greater than 4 months.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Participants must have preserved organ and marrow function as defined by:
• Platelet count ≥ 100,000/mcL.
• Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5x institutional upper limit of normal (ULN).
• Total bilirubin ≤ 3x ULN without liver metastases and \< 5x ULN in presence of liver metastases.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN without liver metastases and \< 5x ULN in the presence of liver metastases
• Estimated creatinine clearance (CrCl \> 30 mL/min).
• Willingness of women of child-bearing potential and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until at least 4 weeks after study completion.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Participants with known brain metastases
• Prior history of documented thromboembolic event within the last 12 months (excluding central line associated events whereby patients completed anticoagulation)
• Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
• History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
• Familial bleeding diathesis
• Known diagnosis of disseminated intravascular coagulation (DIC)
• Currently receiving anticoagulant therapy
• Current daily use of aspirin (\> 100mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g. ibuprofen \> 800mg daily or equivalent)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Known intolerance to the active ingredient of Kinisoquin™, isoquercetin, nicotinic acid, or ascorbic acid (including known G6PD deficiency)
• Females of child-bearing potential who are lactating, have a positive pregnancy test at Screening, or are unwilling to use acceptable contraception prior to study entry and for the duration of study participation until at least 4 weeks after study completion.
• Participation in other clinical trials The study is open to any individual who has a metastatic or locally advanced pancreatic adenocarcinoma malignancy without discrimination based on race, religion, political affiliation, or other criteria.