The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advance… (NCT06861088) | Clinical Trial Compass
RecruitingPhase 3
The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer
United States480 participantsStarted 2025-12-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Participants must have histological or cytological confirmed pancreatic adenocarcinoma malignancy that is metastatic (including recurrent with distant metastases) or locally advanced.
âś“. 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.
âś“. Minimum age 18 years.
âś“. Life expectancy of greater than 4 months.
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
âś“. Participants must have preserved organ and marrow function as defined by:
âś“. 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.
âś“. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
âś•. Participants with known brain metastases
âś•. Prior history of documented thromboembolic event within the last 12 months (excluding central line associated events whereby patients completed anticoagulation)
âś•. Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
âś•. History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
âś•. Familial bleeding diathesis
âś•. Known diagnosis of disseminated intravascular coagulation (DIC)
âś•. Currently receiving anticoagulant therapy
âś•. 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)