The Effect of Kinisoquin on Thromboembolic Events in Patients With Metastatic Pancreatic Cancer (CATIQ P3)

Quercis Pharma

Status and phase: Enrolling; Phase 3

Conditions: Venous Thromboembolism; Metastatic Pancreatic Cancer

Treatments: Drug: Kinisoquin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06861088

IQC-CAT-301

Details and patient eligibility

About

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 pancreatic cancer.

Full description

Approximately one-third of all pancreatic cancer patients suffer from a venous thromboembolism (VTE). The greatest risk of thrombosis is observed in the first three months following the start of chemotherapy. The development of distant metastasis in pancreatic cancer increases the risk of VTE approximately 4-fold.

Kinisoquin is a more bioavailable form of quercetin, a naturally occurring flavonol, intended to prevent thromboembolic events in cancer patients. The aim of this study is to evaluate the efficacy of Kinisoquin in prevention of thromboembolic events in patients with metastatic pancreatic cancer.

This trial is a randomized, placebo-controlled, double-blinded, Phase 3 trial in metastatic pancreatic cancer patients who are initiating chemotherapy.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 3 patient groups, including a placebo group

Kinisoquin 1000mg

Experimental group

Description:

Initially, patients will be randomized on a 1:1:1 basis to Kinisoquin 1000mg, Kinisoquin 2000mg or matching placebo daily. Patients in the 1,000 mg group will receive Kinisoquin at a total daily dose of 1,000 mg, administered orally as two 250 mg Kinisoquin capsules and two placebo capsules in the morning, and two 250 mg Kinisoquin capsules and two placebo capsules in the evening (total of 8 capsules daily) for 16 weeks. An interim analysis will be performed when 26 primary endpoint events have been attained across all three arms and the best performing dose will be identified and a sample size reassessment performed. Thereafter, randomization to the study will continue only for the selected dose and placebo on a 1:1 basis.

Treatment:

Drug: Kinisoquin

Kinisoquin 2000mg

Experimental group

Description:

Initially, patients will be randomized on a 1:1:1 basis to Kinisoquin 1000mg, Kinisoquin 2000mg or matching placebo daily. Patients in the 2,000 mg group will receive Kinisoquin at a total daily dose of 2,000 mg, administered orally as four 250 mg Kinisoquin capsules in the morning and four 250 mg Kinisoquin capsules in the evening (total of 8 capsules daily) for 16 weeks. An interim analysis will be performed when 26 primary endpoint events have been attained across all three arms and the best performing dose will be identified and a sample size reassessment performed. Thereafter, randomization to the study will continue only for the selected dose and placebo on a 1:1 basis.

Treatment:

Drug: Kinisoquin

Placebo

Placebo Comparator group

Description:

Patients in this group will be administered placebo orally at 8 capsules per day for 16 weeks (4 capsules in the morning and 4 capsules in the evening).

Treatment:

Drug: Placebo