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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24889

Enrollment

Registered

2009-03-31

Start date

2009-06-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

relationship between the CYP3A and CYP2D6 probe dextromethorphan and the pharmacokinetics of tamoxifen in breast cancer patients who require tamoxifen monotherapy

Interventions

Observational study with pharmacokinetic sampling.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological or cytological confirmed history of breast cancer for which treatment with tamoxifen monotherapy is indicated; 2. Age> or = 18 years; 3. WHO 0 or 1; 4. Adequate renal and hepatic functions; 5. Adequate hematological function; 6. Written informed consent; 7. Use of tamoxifen monotherapy for at least 3 weeks.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients; 2. Patients with reproductive potential must use a reliable method of contraception; 3. Impossibility to take oral drugs; 4. Serious illness or medical unstable condition requiring treatment; 5. Symptomatic CNS-metastases or history of psychiatric disorder that would prohibit the understanding and giving of ijnformed consent; 6. Unwillingness to abstain form grapefruit (juice), (herbal) dietary supplements, herbals and over the counter medication (except paracetamol and ibuprofen) and other drugs known for to seriously interact with CYP3A and/or ABCB1 and/or ABCG2 during the study period; 7. Use of strong CYP3A and/or P-glycoprotein inhibiting and inducing medication, dietary supplements or other inhibiting compounds.

Design outcomes

Primary

Measure	Time frame
Relationships between dextromethorphan clearance and the clearance of tamoxifen in breast cancer patients.	—

Secondary

Measure	Time frame
Relationships between other PK-parameters (AUC, Cmax and Tmax); effects of known polymorphisms in CYP2D6 and CYP3A and other relevant drug metabolizing enzymes and transporters on the pahrmacokinetics of tamoxifen and dextromethorphan.	—

Contacts

Public ContactFilip Vos, de

f.devos@erasmusmc.nl+31 (0)107041906

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)