Kinisoquin to prevent blood clots in people with advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 trial enrolling patients with metastatic or locally advanced pancreatic adenocarcinoma who are initiating first-line chemotherapy. Participants are assigned to oral Kinisoquin, a more bioavailable form of the flavonol quercetin, or matching placebo and are followed for venous thromboembolic events and safety outcomes. The study targets the high-risk period for thrombosis that occurs shortly after chemotherapy initiation and collects clinical and laboratory data to monitor clotting and organ function. Enrollment is at multiple U.S. centers and requires preserved marrow, liver, and coagulation function and an ECOG performance status of 0–2.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Mukesh Kumar, PhD
• Email: mkumar@fdamap.com
• Phone: 240-750-4893

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• DoACs vs LMWH for blood flow after knee replacement

  This study tests whether rivaroxaban, apixaban, or LMWH work differently to support blood flow in the legs after total knee replacement in adults.

  Recruiting Military Hospital of Tunis · Tunis, Tunis Governorate · NCT07869615

• Prognostic value of the 2026 AHA/ACC PE classification in ED patients with acute PE

  This study tests whether the 2026 AHA/ACC five-category PE classification helps predict 30-day major adverse pulmonary embolism events in adults with acute PE presenting to the ED.

  Recruiting Marmara University Pendik Training and Research Hospital · Istanbul · NCT07805616

• First-line combo therapy with GnP, SHR-1701, and Apatinib for metastatic pancreatic cancer

  This trial tests whether adding SHR-1701 and Apatinib to standard GnP can safely and effectively treat previously untreated metastatic pancreatic cancer.

  Recruiting Phase 1/2 West China Hospital · Chengdu, Sichuan · NCT07802184

• AB801 with chemotherapy and immunotherapy for cholangiocarcinoma and pancreatic cancer

  This phase 1 study tests whether AB801 can be given safely with chemotherapy and immunotherapy in adults with border-line resectable, locally advanced, or metastatic cholangiocarcinoma or pancreatic cancer.

  Recruiting Phase 1 Jonsson Comprehensive Cancer Center · Los Angeles, California · NCT07619313

• Screening for blood clots in adults with acute heart failure

  This trial tests whether a guideline-based screening approach can detect pulmonary embolism in adults admitted with acute heart failure.

  Recruiting University Hospital, Angers · Agen and 9 other locations · NCT07499661

• Setidegrasib with mFOLFIRINOX or NALIRIFOX for KRAS G12D metastatic pancreatic cancer

  This trial tests whether adding setidegrasib to mFOLFIRINOX or NALIRIFOX helps people with metastatic pancreatic cancer who have a KRAS G12D mutation.

  Recruiting at 104 sites Phase 3 Astellas Pharma Inc · Gilbert, Arizona and 103 other locations · NCT07409272

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.