Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-04-12 @ 5:03 PM
Study NCT ID:
NCT02195232
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cancer Associated Thrombosis and Isoquercetin (CATIQ)
Sponsor:
Jeffrey Zwicker, MD
Organization:
Study Overview
Official Title:
Randomized, Placebo-controlled, Double-blind Phase II/III Trial of Oral Isoquercetin to Prevent Venous Thromboembolic Events in Cancer Patients.
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATIQ
Brief Summary:
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:
* 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.
--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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: