The Effect of Isoquercetin on Thromboembolic Events in Patients with Metastatic Pancreatic Cancer

Launched by QUERCIS PHARMA AG · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a substance called isoquercetin to see if it can help prevent blood clots in patients with advanced pancreatic cancer. Blood clots can be a serious issue for these patients, so finding effective treatments is very important. The trial will compare isoquercetin to a placebo, which means some participants will receive the actual treatment while others will receive a treatment that looks the same but has no active ingredients.

To be eligible for this study, participants must be at least 18 years old and have a confirmed diagnosis of metastatic pancreatic cancer. They should be starting their first round of chemotherapy and expect to live at least six more months. However, individuals with certain health conditions, such as active bleeding issues or previous severe blood clots, cannot participate. If eligible, participants will need to agree to use birth control during the study and will be closely monitored for their health throughout the trial. The study is not yet recruiting, so it's important to stay informed about when it will begin.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must have histological or cytological confirmed advanced pancreatic adenocarcinoma malignancy that is metastatic (including recurrent with distant metastases)
• • 2. Receiving first line chemotherapy (within 30 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 6 months
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• 6. Participants must have preserved organ and marrow function as defined by:
• • Platelet count ≥ 50,000/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. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• • 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 2 years (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 (\> 81mg 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 of (iso)quercetin, niacin, or ascorbic acid (including known G6PD deficiency)
• • 11. Females of child-bearing potential must be non-lactating, must have a negative pregnancy test at Screening, and must agree to continue using contraception throughout the study and for 4 weeks after study completion
• • 12. Participation in other clinical trials