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

Inclusion Criteria:

1. Participants must have histological or cytological confirmed pancreaticadenocarcinoma malignancy that is metastatic (including recurrent with distantmetastases) or locally advanced.

2. Receiving first line chemotherapy (within 45 days of first dose of study drug) Note:subjects must be either initiating first systemic cancer therapy regimen followinginitial diagnosis or initiating first cycle of chemotherapy for disease recurrence.

3. Minimum age 18 years.

4. Life expectancy of greater than 4 months.

5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

6. Participants must have preserved organ and marrow function as defined by:

• Platelet count ≥ 100,000/mcL.

• Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5xinstitutional upper limit of normal (ULN).

• Total bilirubin ≤ 3x ULN without liver metastases and < 5x ULN in presence ofliver metastases.

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULNwithout liver metastases and < 5x ULN in the presence of liver metastases

• Estimated creatinine clearance (CrCl > 30 mL/min).

7. Willingness of women of child-bearing potential and men to use adequatecontraception (hormonal or barrier method of birth control; abstinence) prior tostudy entry and for the duration of study participation until at least 4 weeks afterstudy completion.

8. Ability to understand and the willingness to sign a written informed consentdocument.

Exclusion Criteria:

1. Participants with known brain metastases

2. Prior history of documented thromboembolic event within the last 12 months (excluding central line associated events whereby patients completedanticoagulation)

3. Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)

4. History of significant hemorrhage (requiring hospitalization or transfusion) outsideof a surgical setting within the last 24 months

5. Familial bleeding diathesis

6. Known diagnosis of disseminated intravascular coagulation (DIC)

7. Currently receiving anticoagulant therapy

8. Current daily use of aspirin (> 100mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to useregular use of higher doses of non-steroidal anti-inflammatory agents as determinedby the treating physician (e.g. ibuprofen > 800mg daily or equivalent)

9. Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements

10. Known intolerance to the active ingredient of Kinisoquin™, isoquercetin, nicotinicacid, or ascorbic acid (including known G6PD deficiency)

11. Females of child-bearing potential who are lactating, have a positive pregnancy testat Screening, or are unwilling to use acceptable contraception prior to study entryand for the duration of study participation until at least 4 weeks after studycompletion.

12. Participation in other clinical trials The study is open to any individual who has ametastatic or locally advanced pancreatic adenocarcinoma malignancy withoutdiscrimination based on race, religion, political affiliation, or other criteria.