Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2026-01-31
2032-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort A: Placebo
Placebo
Placebo
Cohort B: Isoquercetin daily
Isoquercetin
Cohort B and Cohort C will take isoquercetin
Cohort C: Isoquercetin twice daily
Isoquercetin
Cohort B and Cohort C will take isoquercetin
Interventions
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Isoquercetin
Cohort B and Cohort C will take isoquercetin
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Minimum age 18 years
* Life expectancy of greater than 6 months.
* ECOG performance status \<2
* Participants must have preserved organ and marrow function as defined below:
* Platelet count \> 50,000/mcL
* Prothrombin time (PT) and partial thromboplastin time (PTT) \< 1.5 x institutional upper limit of normal (ULN)
* Total bilirubin \< 3 x ULN without liver metastases and \<5 x ULN in presence of liver metastases.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 X ULN without liver metastases and \<5 x ULN in the presence of liver metastases.
* Estimated creatinine clearance (CrCl \>30 ml/min)
* 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
* Active bleeding or high risk for bleeding (e.g., known acute gastrointestinal ulcer)
* History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
* Familial bleeding diathesis
* Known diagnosis of disseminated intravascular coagulation (DIC)
* Currently receiving anticoagulant therapy
* Current daily use of aspirin, 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 (iso)quercetin, niacin or ascorbic acid (including known G6PD deficiency).
* Participants with known brain metastases
* 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.
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Zwicker, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Beth Israel Deaconess Medical Center (Data Collection Only)
Boston, Massachusetts, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Robert Flaumenhaft, MD, PhD
Role: primary
Jeffrey A Zwicker, MD
Role: primary
Jeffrey Zwicker, MD
Role: primary
Jeffrey Zwicker, MD
Role: primary
Jeffrey Zwicker, MD
Role: primary
Jeffrey Zwicker, MD
Role: primary
Jeffrey Zwicker, MD
Role: primary
Jeffrey Zwicker, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-060
Identifier Type: -
Identifier Source: org_study_id