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

NCT06861088 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IQC-CAT-301
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Venous Thromboembolism; Metastatic Pancreatic Cancer; Locally Advanced Pancreatic Adenocarcinoma

Keywords

Metastatic Pancreatic Cancer; Pancreatic Adenocarcinoma; Thromboembolism; Cancer-associated Thrombosis; Deep Vein Thrombosis; Pulmonary Embolism; Chemotherapy-associated VTE; Locally Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Risk of TE

  16 weeks

• Catheter-related TEs

  16 weeks

• Risk of major hemorrhage

  16 weeks

• Risk of clinically relevant non-major bleeding

  16 weeks

• Progression-Free Survival (PFS)

  12 months

Study Arms (3)

Kinisoquin™ 1000mg

EXPERIMENTAL

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™ 2000mg

EXPERIMENTAL

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™

Placebo

PLACEBO COMPARATOR

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

Interventions

Kinisoquin™ DRUG

Kinisoquin™ capsules formulated with vitamin C and vitamin B3

Also known as: Isoquercetin

Kinisoquin™ 1000mg; Kinisoquin™ 2000mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histological or cytological confirmed pancreatic adenocarcinoma malignancy that is metastatic (including recurrent with distant metastases) or locally advanced.
• 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.
• Minimum age 18 years.
• Life expectancy of greater than 4 months.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• 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).
• 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.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Participants with known brain metastases
• Prior history of documented thromboembolic event within the last 12 months (excluding central line associated events whereby patients completed anticoagulation)
• Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
• History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
• Familial bleeding diathesis
• Known diagnosis of disseminated intravascular coagulation (DIC)
• Currently receiving anticoagulant therapy
• 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)
• 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
• Known intolerance to the active ingredient of Kinisoquin™, isoquercetin, nicotinic acid, or ascorbic acid (including known G6PD deficiency)
• 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.
• 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.

Sponsors & Collaborators

• Quercis Pharma AG: lead

Study Sites (3)

Ventura Clinical Trials

Ventura, California, 93003, United States

RECRUITING

Clavis Medical, LLC

Miami Lakes, Florida, 33014, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Pancreatic Neoplasms; Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Interventions

isoquercitrin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Central Study Contacts

Mukesh Kumar, PhD

CONTACT

240-750-4893; mkumar@fdamap.com

Kanisha Shah, MSRA

CONTACT

kanishas@fdamap.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: Initially, patients will be randomized on a 1:1:1 basis to Kinisoquin™ 1000 mg, Kinisoquin™ 2000 mg, or matching placebo daily. Kinisoquin™ or placebo will be administered orally at 8 capsules per day for 16 weeks (4 capsules in the morning and 4 capsules in the evening). An interim analysis will be performed when 26 positively adjudicated primary endpoint events have been attained across all three arms, expected to have been accrued after enrolment of the 180th patient. Deselected dose patients will be followed long term for progression-free survival and overall survival but will not be included in the final primary endpoint analysis. Futility will be assessed at the interim and, if passed, the better 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.

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)