The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified December 2025 by Quercis Pharma AG
Sponsor
Quercis Pharma AG
Information Provided by (Responsible Party)
Quercis Pharma AG
Clinicaltrials.gov Identifier
NCT06861088
Other Study ID Numbers:
IQC-CAT-301
First Submitted
February 27, 2025
First Posted
March 5, 2025
Last Update Posted
February 1, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Venous ThromboembolismMetastatic Pancreatic CancerLocally Advanced Pancreatic Adenocarcinoma
Drug: Kinisoquin™Drug: Kinisoquin™Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment480 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposePrevention
Official TitleA 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)
Study Start DateDecember 18, 2025
Actual Primary Completion Date1yr 5mos from now
Actual Study Completion Date3yrs 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Kinisoquin™ 1000mg
Initially, patients will be randomized on a 1:1:1 basis to Kinisoquin™ 1000mg, Kinisoquin™ 2000mg or matching placebo daily. Patients in the 1,000 mg group will receive Kinisoquin™ at a total daily dose of 1,000 mg, administered orally as two 250 mg Kinisoquin™ capsules and two placebo capsules in the morning, and two 250 mg Kinisoquin™ capsules and two placebo capsules in the evening (total of 8 capsules daily) for 16 weeks. An interim analysis will be performed when 26 positively adjudicated primary endpoint events have been attained across all three arms and the best performing dose will be identified and a sample size reassessment performed. Thereafter, randomization to the study will continue only for the selected dose and placebo on a 1:1 basis.
Drug: Kinisoquin™
Kinisoquin™ capsules formulated with vitamin C and vitamin B3
Kinisoquin™ 2000mg
Initially, patients will be randomized on a 1:1:1 basis to Kinisoquin™ 1000mg, Kinisoquin™ 2000mg or matching placebo daily. Patients in the 2,000 mg group will receive Kinisoquin™ at a total daily dose of 2,000 mg, administered orally as four 250 mg Kinisoquin™ capsules in the morning and four 250 mg Kinisoquin™ capsules in the evening (total of 8 capsules daily) for 16 weeks. An interim analysis will be performed when 26 positively adjudicated primary endpoint events have been attained across all three arms and the best performing dose will be identified and a sample size reassessment performed. Thereafter, randomization to the study will continue only for the selected dose and placebo on a 1:1 basis.
Drug: Kinisoquin™
Kinisoquin™ capsules formulated with vitamin C and vitamin B3
Placebo
Patients in this group will be administered placebo orally at 8 capsules per day for 16 weeks (4 capsules in the morning and 4 capsules in the evening).
Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. 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.
Secondary Outcome Measures
  1. 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.
  2. 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.
  3. 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
  4. 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.
  5. 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.
  6. Overall Survival (OS)
    Overall survival until 24 months after study treatment initiation in patients treated with Kinisoquin™ compared with placebo.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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. 6. Participants must have preserved organ and marrow function as defined by:
Platelet count ≥ 100,000/mcL.
Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5x institutional upper limit of normal (ULN).
Total bilirubin ≤ 3x ULN without liver metastases and \< 5x ULN in presence of liver metastases.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN without liver metastases and \< 5x ULN in the presence of liver metastases
Estimated creatinine clearance (CrCl \> 30 mL/min). 7. Willingness of women of child-bearing potential and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until at least 4 weeks after study completion. 8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
1. Participants with known brain metastases 2. Prior history of documented thromboembolic event within the last 12 months (excluding central line associated events whereby patients completed anticoagulation) 3. Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer) 4. History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months 5. Familial bleeding diathesis 6. Known diagnosis of disseminated intravascular coagulation (DIC) 7. Currently receiving anticoagulant therapy 8. Current daily use of aspirin (\> 100mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g. ibuprofen \> 800mg daily or equivalent) 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 10. Known intolerance to the active ingredient of Kinisoquin™, isoquercetin, nicotinic acid, or ascorbic acid (including known G6PD deficiency) 11. Females of child-bearing potential who are lactating, have a positive pregnancy test at Screening, or are unwilling to use acceptable contraception prior to study entry and for the duration of study participation until at least 4 weeks after study completion. 12. Participation in other clinical trials The study is open to any individual who has a metastatic or locally advanced pancreatic adenocarcinoma malignancy without discrimination based on race, religion, political affiliation, or other criteria.

Contacts and Locations

Sponsors and CollaboratorsQuercis Pharma AG
Locations
Ventura Clinical Trials | Ventura California, United States, 93003Clavis Medical, LLC | Miami Lakes Florida, United States, 33014Beth Israel Deaconess Medical Center | Boston Massachusetts, United States, 02215