A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators plan to examine endoxifen and 4-OH-Tam as a function of the tamoxifen dose in patients with a genetic CYP2D6 polymorphism. The investigators also plan to investigate other genetic variations in the metabolism of tamoxifen.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

• Women taking tamoxifen 20mg a day

• Tamoxifen use for > 90 days.

• Use an accepted barrier form of contraception.

Exclusion Criteria:

• Patients are excluded if they are pregnant or lactating; if pre- menopausal, the patient will have a documented negative pregnancy test and use an accepted barrier form of contraception.

• Patients are excluded if they have a medical history of Hepatitis B. Hepatitis C or HIV

• Patients are excluded if they use Tobacco

• Patients are excluded if they have a medical history of hereditary hemochromatosis

• Patients are excluded if they have elevated AST (SGOT), ALT (SGPT), Bilirubin or Alkaline Phosphate

o Defined as greater than 2 1/2 times the upper limit of normal

• Patients are excluded if they are being treated with chemotherapy

• Patients are excluded if they are taking any of the following oral medications, as they are potent CYP2D6 inhibitors:

• Fluoxetine (Prozac)

• Miconazole (Monistat)

• Paroxetine (Paxil)

• Quinidine

• Ritonavir (Norvir)

• Atorvastatin (Lipitor)

• Carvedilol (Coreg)

• Clarithromycin (Biaxin)

• Dipyridamole (Persantine)

• Erythromycin

• Grapefruit Juice

• Itraconazole (Sporanox)

• Ketoconazole

• Mefloquine

• Nelfinavir (Viracept)

• Nicardipine (Cardene)

• Nilotinib

• Propranolol (Inderal)

• Ranolazine (Ranexa)

• Saquinavir ( Invirase)

• Verapamil Covera-HS

• Warfarin (Coumadin)

• Chlorpromazine (Thorazine)

• Cinacalcet (Sensipar)

• Delavirdine (Rescriptor)