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

NCT00900744 | Completed FDA Drug

• 3 other identifiers: GCO 08-1373IF#1248430HSM10-00403
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Tamoxifen; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Specific human 2D6 variants measurement(s) or observation(s)

  every two weeks

Study Arms (1)

Tamoxifen

20mg daily

Drug: Tamoxifen

Interventions

Tamoxifen DRUG

20 mg daily

Also known as: Nolvadex®

Tamoxifen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with a genetic CYP2D6 polymorphism

You may qualify if:

• Women taking tamoxifen 20mg a day
• Tamoxifen use for \> 90 days.
• Use an accepted barrier form of contraception.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• George Raptis, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: August 25, 2017

Record last verified: 2017-08

Locations

US (1)