A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6 (NCT00900744) | Clinical Trial Compass
CompletedNot Applicable
A Pilot Study of Varying Doses of Tamoxifen in the Setting of Genetic Polymorphisms of CYP2D6
United States121 participantsStarted 2009-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Delavi…
What they're measuring
1
Specific human 2D6 variants measurement(s) or observation(s)