Recruiting
Phase 3

Kinisoquin

Sponsor:

Quercis Pharma AG

Code:

NCT06861088

Conditions

Venous Thromboembolism

Metastatic Pancreatic Cancer

Locally Advanced Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Kinisoquin™

Placebo

Study Details

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

Study ID

NCT06861088

Start date

Dec 19, 2025

Status verified date

Jan, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

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).

Interventions

Kinisoquin™

Kinisoquin™ capsules formulated with vitamin C and vitamin B3

Placebo

Placebo

Primary outcome measure

  • Effectiveness of Kinisoquin™ [ Time Frame: 16 weeks ]
  • Effectiveness of Kinisoquin™ [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Kanisha Shah, MSRA

kanishas@fdamap.com

Locations

Ventura Clinical Trials

Recruiting

Ventura, California, United States, 93003

Clavis Medical, LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Quercis Pharma AG

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Quercis Pharma AG on 2026-02-02.