Phase 3
N=64
Cancer Associated Thrombosis and Isoquercetin (CATIQ)
Thromboembolism of Vein VTE in Colorectal Cancer · Thromboembolism of Vein in Pancreatic Cancer · Thromboembolism of Vein in Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02195232 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Percent Change in D-dimer Value — 9.9; -21.9 percent change — p=0.92
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Isoquercetin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jeffrey Zwicker, MD
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in D-dimer Value |
9.9; -21.9 | 0.92 |
| SECONDARY Number of Participants With Hemorrhage |
2; 2 | — |
| SECONDARY Cumulative Incidence of VTE at 56 Days |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants must meet the following criteria on screening examination to be eligible to participate in phase 2 and 3 of the study:
- Participants must have histologically confirmed malignancy that is metastatic or currently unresectable.
- Eligible malignancies include:
- Adenocarcinoma of the pancreas (currently unresectable or metastatic)
- Colorectal (stage IV)
- Non-small cell lung cancer (currently unresectable stage III or stage IV)
- Receiving or scheduled to receive first or second line chemotherapy (within 30 days of registration)
- Minimum age 18 years. Because limited dosing or adverse event data are currently available on the use of isoquercetin in participants 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 > 800 mg daily or equivalent).
- 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.
- Known intolerance of niacin or ascorbic acid (including known G6PD deficiency)
- Pregnant women are excluded from this study because isoquercetin is a PDI inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with isoquercetin, breastfeeding should be discontinued if the mother is treated with isoquercetin. These potential risks may also apply to other agents used in this study.
Data sourced from ClinicalTrials.gov (NCT02195232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.