Actively Recruiting
The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer
Led by Quercis Pharma AG · Updated on 2026-02-02
480
Participants Needed
3
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of metastatic or locally advanced pancreatic adenocarcinoma
- Starting first line chemotherapy within 45 days of first study drug dose
- Age 18 years or older
- Life expectancy greater than 4 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate organ and marrow function including platelet count 30,000/mcL, PT and PTT 3D 1.5 times upper limit of normal (ULN), bilirubin 3D 3 times ULN without liver metastases or < 5 times ULN with liver metastases, AST and ALT 3D 3 times ULN without liver metastases or < 5 times ULN with liver metastases, and creatinine clearance > 30 mL/min
- Willingness to use contraception if of child-bearing potential during and for 4 weeks after study
- Ability to understand and sign informed consent
You will not qualify if you...
- Known brain metastases
- History of thromboembolic event within the past 12 months (except central line associated events with completed anticoagulation)
- Active bleeding or high bleeding risk (e.g., acute gastrointestinal ulcer)
- Significant hemorrhage requiring hospitalization or transfusion within last 24 months
- Familial bleeding disorders
- Diagnosis of disseminated intravascular coagulation (DIC)
- Currently receiving anticoagulant therapy
- Daily use of aspirin > 100 mg, clopidogrel, cilostazol, aspirin-dipyridamole within 10 days, or regular high-dose NSAIDs
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Known intolerance to Kinisoquin12 ingredients including G6PD deficiency
- Females lactating, pregnant, or unwilling to use contraception during study and for 4 weeks after
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Ventura Clinical Trials
Ventura, California, United States, 93003
Actively Recruiting
2
Clavis Medical, LLC
Miami Lakes, Florida, United States, 33014
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
M
Mukesh Kumar, PhD
CONTACT
K
Kanisha Shah, MSRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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