The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This Phase 3 study tests whether Kinisoquin™ helps prevent blood clots compared with a placebo, which has no active drug. It is for adults with pancreatic cancer that has spread to nearby areas or distant parts of the body.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- Tissue or cell tests show pancreatic adenocarcinoma, a type of pancreatic cancer, that has spread nearby or to distant parts of the body.
- You are starting your first chemotherapy after diagnosis or for cancer that has returned, within 45 days of your first study drug dose.
- You are expected to live more than 4 months.
- You can care for yourself and are out of bed or a chair for more than half of your waking hours (ECOG score 0–2).
- Your blood cell counts, blood clotting, liver function, and kidney function meet the study’s test limits.
- Men and women who can become pregnant agree to use birth control or avoid sex before entry, during the study, and for at least 4 weeks after it ends.
- You can understand the study and agree to sign a consent form.
Who can't join
- Your cancer has spread to your brain.
- You had a blood clot in the past 12 months, unless it was linked to a central line and you finished blood-thinner treatment.
- You have active bleeding, a high bleeding risk, an inherited bleeding disorder, or DIC, a condition that causes abnormal clotting and bleeding. You also cannot join if you had bleeding outside surgery that needed a hospital stay or blood transfusion in the past 24 months.
- You take blood thinners, or have used daily aspirin over 100 mg, clopidogrel, cilostazol, or aspirin-dipyridamole within 10 days. Regular high-dose anti-inflammatory pain drugs, such as ibuprofen over 800 mg daily, may also rule you out.
- You have an uncontrolled illness, such as an active infection or certain heart problems, or mental health or life circumstances that would keep you from following study rules.
- You cannot tolerate Kinisoquin’s active ingredient, isoquercetin, nicotinic acid, or ascorbic acid, or you have G6PD deficiency, an inherited condition affecting red blood cells.
- You are breastfeeding, have a positive pregnancy test at screening, or could become pregnant but will not use the required birth control.
- You are taking part in another clinical trial.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (3)
CA
- Ventura Clinical Trials · Ventura, CA 93003More trials in Ventura
FL
- Clavis Medical, LLC · Miami Lakes, FL 33014More trials in Miami Lakes
MA
- Beth Israel Deaconess Medical Center · Boston, MA 02215More trials in Boston