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)
Quercis Pharma AG
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must have histological or cytological confirmed pancreatic adenocarcinoma malignancy that is metastatic (including recurrent with distant metastases) 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 following initial 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…
Interventions
- DrugKinisoquin™
Kinisoquin™ capsules formulated with vitamin C and vitamin B3
- DrugPlacebo
Placebo
Locations (3)
- Ventura Clinical TrialsVentura, California
- Clavis Medical, LLCMiami Lakes, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts