Studying the relationship between the CYP3A and CYP2D6 probe dextromethorphan and the pharmackinetics of tamoxifen.

Studying the relationship between the CYP3A and CYP2D6 probe dextromethorphan and the pharmackinetics of tamoxifen. - Relationship between CYP3A and CYP2D6 probe and PK of tamoxifen

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33769

Enrollment

Registered

2009-04-14

Start date

2009-06-15

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histological or cytological confirmed breast cancer indication for treatment with monotherapy tamoxifen 18 years of age or older written informed consent adequate renal, hepatological and hematological lab results

Exclusion criteria

Exclusion criteria: pregnant or lactating women impossibility for oral intake medication serious illness or instable medical condition symptomatic central nervous system metastases use of strong CYP3A and/or P-glycoprotein inhibiting and inducing medication/supplements

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic sampling for tamoxifen and dextromethorphan. The relationship between clearance of tamoxifen and of dextromethorphan.	—

Secondary

Measure	Time frame
The intra-patient variability in pharmacokinetics of tamoxifen and dextromethorphan. The effects of known polymorfismes in CYP2D6 and CYP3A and other relevant medication metabolizing enzyms and transporters for the pharmacokinetics of tamoxifen and dextromethorphan.	—

Countries

Netherlands

Outcome results