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.
Approximately one-third of all pancreatic cancer patients suffer from a venous thromboembolism (VTE). The greatest risk of thrombosis is observed in the first three months following the start of chemotherapy. The development of distant metastasis in pancreatic cancer increases the risk of VTE approximately 4-fold. Kinisoquin™ is a more bioavailable form of quercetin, a naturally occurring flavonol, intended to prevent thromboembolic events in cancer patients. The aim of this study is to evaluate the efficacy of Kinisoquin™ in prevention of thromboembolic events in patients with metastatic or locally advanced pancreatic cancer. This trial is a randomized, placebo-controlled, double-blinded, Phase 3 trial in metastatic or locally advanced pancreatic cancer patients who are initiating chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
480
Kinisoquin™ capsules formulated with vitamin C and vitamin B3
Placebo
Ventura Clinical Trials
Ventura, California, United States
RECRUITINGClavis Medical, LLC
Miami Lakes, Florida, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGEffectiveness 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.
Time frame: 16 weeks
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.
Time frame: 16 weeks
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.
Time frame: 16 weeks
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.
Time frame: 16 weeks
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
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Time frame: 16 weeks
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.
Time frame: 16 weeks
Progression-Free Survival (PFS)
Progression-free survival until 12 months after study treatment initiation according to RECIST, as assessed by the site Investigator's review, in patients treated with Kinisoquin™ compared with placebo.
Time frame: 12 months
Overall Survival (OS)
Overall survival until 24 months after study treatment initiation in patients treated with Kinisoquin™ compared with placebo.
Time frame: 24 Months