The Effect of Kinisoquin on Thromboembolic Events in Patients With Metastatic Pancreatic Cancer

Inclusion Criteria:

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

2. Receiving first line chemotherapy (within 30 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 6 months

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

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

• Platelet count ≥ 50,000/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. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry andfor the duration of study participation

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 2 years (excludingcentral line associated events whereby patients completed anticoagulation)

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 (> 81mg 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 of (iso)quercetin, niacin, or ascorbic acid (including known G6PDdeficiency)

11. Females of child-bearing potential must be non-lactating, must have a negativepregnancy test at Screening, and must agree to continue using contraceptionthroughout the study and for 4 weeks after study completion

12. Participation in other clinical trials