About this trial

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.

Eligibility criteria

Qualifiers

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: subjects must be either initiating first systemic cancer therapy regimen following initial diagnosis or initiating first cycle of chemotherapy for disease recurrence.

Minimum age 18 years.

Life expectancy of greater than 4 months.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Kinisoquin™
  • Placebo

Treatment groups

480 Participants
are divided into 3 treatment groups

Locations

3
Ventura Clinical Trials93003, VenturaCalifornia, United States
Clavis Medical, LLC33014, Miami LakesFlorida, United States
Beth Israel Deaconess Medical Center02215, BostonMassachusetts, United States

Sponsors and collaborators

Quercis Pharma AG

Lead sponsor