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New treatment option for Venous Thromboembolism
Official title The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT06861088
What this study is testing
What is Kinisoquin™?
Kinisoquin™ is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for venous thromboembolism.
Also referred to as Isoquercetin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histological or cytological confirmed pancreatic adenocarcinoma malignancy that is metastatic (including recurrent with...
- Receiving first line chemotherapy (within 45 days of first dose of study drug) Note: people must be either initiating first systemic cancer therapy...
- Minimum age 18 years.
- Life expectancy of greater than 4 months.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
You likely can't join 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...
- 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)
See the full eligibility criteria
- 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: people must be either initiating first systemic cancer therapy regimen following initial diagnosis or initiating first cycle of...
- 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...
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ventura, California, United States
- Miami Lakes, Florida, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ventura, California, United States; Miami Lakes, Florida, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.