Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age ≥ 70 years
Exclusion Criteria
- Unable or unwilling to give informed consent
- Pregnant
- Body weight >150 kg or body mass index (BMI) > 50
- QTc>450 msec
- Total bilirubin >2X upper limit of normal
- Inability to tolerate oral medication
- Abnormality in any of the screening laboratory studies (see below)
- Human immunodeficiency virus infection
- Known active hepatitis B or C infection
- Invasive fungal or viral infection
- Known hypersensitivity or allergy to fisetin
- Uncontrolled pleural/pericardial effusions or ascites
- New/active invasive cancer except non-melanoma skin cancers
- Subjects taking medications that are sensitive to substrates or substrates with a
narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or
inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are
absolutely necessary from an infectious disease perspective, then they will be allowed
only if the levels are therapeutic.
- Strong inhibitors of CYP3A4. See Appendices 1-3.
- Tyrosine kinase inhibitor therapy
- Known hypersensitivity or allergy to fisetin
- Subjects on quinolone antibiotic therapy for treatment or for prevention of infections
within 10 days.
- Subjects taking H2-antagonists and unwilling to discontinue therapy for 1 week before
and 2 weeks following enrollment.
- Subjects taking potentially senolytic agents within the last year: Fisetin, Quercetin,
Luteolin, Dasatinib, Piperlongumine, or Navitoclax
- Subjects currently taking drugs that induce cellular senescence: alkylating agents,
anthracyclines, platins, other chemotherapy
- Subjects taking the following antimicrobial agents: Aminoglycosides, Azole antifungals
(fluconazole, miconazole, voriconazole, itraconazole), Macrolides
(clarithromycin,erythromycin), Antivirals (nelfinavir, indinavir, saquinavir,
ritonavir, elbasvir/grazoprevir), Rifampin
- Subjects taking proton pump inhibitors who are unable or unwilling to reduce or hold
therapy 2 days prior to and during the 2-day Fisetin dosing
- Subjects taking the following other drugs if they cannot be held for at least 2 days
before and during administration of Fisetin: digoxin, lithium, all statins,
repaglidine, bosentan, gemfibrozil, olmesartan, enalapril, valsartan, methotrexate,
corticosteroids, , eluxadoline, eltrombopag, nitroglycerin, pioglitazone, glyburide,
enzalutamide, ezetimibe, colchicine, imatinib, cyclosporine, tacolimus, sirolimus,
carbamazepine, flecainide, phenytoin, phenobarbital, rifampicin, theophylline,
celecoxib, desipramine, thioridazine, venlafaxine, tizanidine, atomoxetine,
voriconazole, citalopram, diazepam, escitalopram, propranolol, clozapine,
cyclobenzaprine, mexiletine, olanzapine, ondansetron, riluzole
- In order to ensure vitamin D sufficiency, we will also exclude subjects with serum
25-hydroxyvitamin D levels of < 20 ng/ml.
- Presence of any condition that the Investigator believes would put the subject at risk
or would preclude the patient from successfully completing all aspects of the trial.
Behavioral Modification - Participants will be educated about the risk of excessive
caffeine usage. Participants will be encouraged to reduce use by 50% prior to and during
the 2-day drug dosing period. Due to drug-drug interaction, subjects may not clear the
caffeine from their system properly/as usual.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.