The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer (CATIQ P3)

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Thromboembolism; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: Placebo; Drug: Kinisoquin™

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.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mukesh Kumar, PhD; Phone Number: 240-750-4893; Email: mkumar@fdamap.com
• Study Contact Backup: Name: Kanisha Shah, MSRA; Email: kanishas@fdamap.com

Study Locations

• United States
  • California
    • Ventura, California, United States, 93003
      • Recruiting
      • Ventura Clinical Trials
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • Recruiting
      • Clavis Medical, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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
Experimental: 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; Other Names: Isoquercetin
Experimental: 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; Other Names: Isoquercetin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	12 months
Overall Survival (OS)	Overall survival until 24 months after study treatment initiation in patients treated with Kinisoquin™ compared with placebo.	24 Months

Collaborators and Investigators

• Sponsor: Quercis Pharma AG

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Deep Vein Thrombosis; Locally Advanced Pancreatic Cancer; Thromboembolism; Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma; Pulmonary Embolism; Cancer-associated Thrombosis; Chemotherapy-associated VTE
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Pulmonary Embolism; Venous Thrombosis; Pancreatic Neoplasms; Thromboembolism; Venous Thromboembolism; isoquercitrin
• Other Study ID Numbers: IQC-CAT-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No