The aim of this Phase 3 study is to evaluate the efficacy of Kinisoquin™ as compared to the placebo in prevention of thromboembolic events in patients with metastatic or locally advanced pancreatic cancer.
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.
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
Parallel
Kinisoquin™
DrugKinisoquin™ capsules formulated with vitamin C and vitamin B3
Placebo
DrugPlacebo
Effectiveness of Kinisoquin™
The time to the first positively adjudicated thromboembolic event (TE) over 16 weeks of treatment in patients treated with Kinisoquin™ compared with placebo.
Effectiveness of Kinisoquin™
The time to the first positively adjudicated proximal or distal lower extremity DVT, any pulmonary embolism, fatal pulmonary embolism diagnosed on autopsy, catheter-related thrombosis, visceral thrombosis or arterial thrombosis. Events will be classified as incidental or symptomatic: incidental TE will be so classified if the imaging was ordered primarily for staging or re-staging or conducted for reasons other than identification of a thrombosis as compared to the placebo.
Risk of TE
To assess the risk of TE defined as proximal or distal lower extremity DVT, any pulmonary embolism, fatal pulmonary embolism diagnosed on autopsy, or arterial thrombosis over 16 weeks of treatment in patients treated with Kinisoquin™ compared with placebo.
Catheter-related TEs
To assess the risk of catheter-related TEs over 16 weeks after study treatment initiation in patients treated with Kinisoquin™ compared with placebo.
Risk of major hemorrhage
To assess the risk of major hemorrhage in patients treated with Kinisoquin™ compared with placebo according to ISTH definition. The criteria for major hemorrhage in non-surgical patients is: * Fatal bleeding, and/or * Symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or * Bleeding causing a fall in hemoglobin level ≥ 2 g/L or * Bleeding leading to a transfusion ≥ 2 units of packed red blood cells
Risk of clinically relevant non-major bleeding
To assess the risk of clinically relevant non-major bleeding in patients treated with Kinisoquin™ compared with placebo.
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