A Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial Comparing, Relative to Placebo, the Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer (CATIQ P3)
Summary
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.
Detailed description
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.
Arms & interventions
- DrugKinisoquin™
Kinisoquin™ capsules formulated with vitamin C and vitamin B3
- DrugPlacebo
Placebo
Outcome measures
Primary
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.
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
Secondary
Risk of TE
Time frame: 16 weeks
Catheter-related TEs
Time frame: 16 weeks
Risk of major hemorrhage
Time frame: 16 weeks
Risk of clinically relevant non-major bleeding
Time frame: 16 weeks
Progression-Free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 24 Months
Eligibility criteria
Study locations (3)
Ventura Clinical Trials
Ventura, California, 93003
Clavis Medical, LLC
Miami Lakes, Florida, 33014
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215