Pancreatic Cancer Research

Clinical trialPhase 2 / Phase 3Completed

Cancer Associated Thrombosis and Isoquercetin (CATIQ)

Randomized, Placebo-controlled, Double-blind Phase II/III Trial of Oral Isoquercetin to Prevent Venous Thromboembolic Events in Cancer Patients.

NCT02195232↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Outcome unknown
Phase
Phase 2 / Phase 3
Status
Completed
Study type
Interventional
Start
January 2015
Expected end
22 October 2019
Enrollment
64 participants
Sites
11
Primary outcomes
Percent Change in D-dimer Value
Sponsor
Other
Results posted
2019-11-12
Last update
3 March 2021

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Brief summary public domain (ClinicalTrials.gov)

This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung cancer or colorectal cancer.

Detailed description public domain (ClinicalTrials.gov)

* This research study is a Phase II/III clinical trial. --The goal of this trial is to evaluate if isoquercetin can prevent blood clots in patients with pancreas, non small cell lung cancer or colorectal cancer. In the Phase II part of this study, the investigators are looking for the dose of isoquercetin to reduce D-dimer and demonstrate safety. * Phase III Endpoint and Treatment Plan * Primary Endpoint for Phase III portion of protocol: Cumulative incidence of VTE. * Following the completion of the phase II portion, enrolled patients will be randomized 1:1 to Arm C (isoquercetin) or Arm D (placebo). The dose for Arm C will be determined after evaluation of the Phase II portion of the trial. The protocol will be amended when the decision is made whether to proceed to Phase III and what dose to use for Arm C. The study will be double-blinded to treatment arm. Lower extremity ultrasound will be performed at 56 days. Baseline D-dimer and correlative labs will be drawn at Day 1 and at 56 days. Patients will be followed for survival after completion of 56 days. * At BIDMC, optional blood draw will be performed at time 0 and 4 hours following the first dose of study drug.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Percent Change in D-dimer Value [Baseline, 56 Day]. Median, percent change (Full Range). Cohort A (Isoquercetin 500 mg) (n=28): 9.9 (-51.1 to 74.2); Cohort B (Isoquercetin 1000 mg) (n=29): -21.9 (-63.3 to 36.5). Analysis, Cohort A (Isoquercetin 500 mg) vs Cohort B (Isoquercetin 1000 mg): p=0.92; t-test, 2 sided; other.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Hemorrhage [study visits until day 56]. Count Of Participants, Participants. Cohort A (Isoquercetin 500 mg) (n=28): 2; Cohort B (Isoquercetin 1000 mg) (n=29): 2.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Cumulative Incidence of VTE at 56 Days [56 days]. Number, participants. Cohort A - Isoquercetin (n=28): 0; Cohort B - Isoquercetin (n=29): 0.

Papers 1

The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.