The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer

Part of paid clinical trials in Ventura, California.

Sponsor
Quercis Pharma AG
Study ID
NCT06861088
Phase
PHASE3
Status
Recruiting
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Conditions

  • Locally Advanced Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Cancer
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kinisoquin™ — DRUG
    Kinisoquin™ capsules formulated with vitamin C and vitamin B3
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Dec 19, 2025
Status verified
Jan 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2029

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Kinisoquin™ 1000mg
    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 positively adjudicated 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.
  • Experimental: Kinisoquin™ 2000mg
    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 positively adjudicated 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.
  • Placebo Comparator: Placebo
    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).

Primary Outcome Measure

Effectiveness of Kinisoquin™ [ Time Frame: 16 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Ventura Clinical TrialsVenturaCalifornia93003-
Clavis Medical, LLCMiami LakesFlorida33014-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

Find similar trials in Ventura, CA

By research site
Ventura Clinical Trials· Ventura, CAClavis Medical, LLC· Miami Lakes, FLBeth Israel Deaconess Medical Center· Boston, MA

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