Status and phase
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About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
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:
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 <18 years of age, children are excluded from this study but will be eligible for future pediatric isoquercetin trials.
Life expectancy of greater than 4 months.
ECOG performance status ≤2 (see Appendix B ).
Patient must be able to swallow capsules (phase III only)
Participants must have preserved organ and marrow function as defined below:
The effects of isoquercetin on the developing human fetus are unknown. For this reason, 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
64 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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