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


- candidate number5531
- NTR NumberNTR1751
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mrt-2009
- Secondary IDs09-YYY MEC
- Public TitleStudying the relationship between the CYP3A and CYP2D6 probe dextromethorphan and the pharmacokinetics of tamoxifen.
- Scientific TitleStudying the relationship between the CYP3A and CYP2D6 probe dextromethorphan and the pharmacokinetics of tamoxifen.
- ACRONYMN/A
- hypothesisIn this observational trial we would like to study the possible correlation between the probe-drug dextromethrophan and tamoxifen pharmacokinetics. In case a good correlation is available, this might help in a stepwise development of truly individualizing tamoxifen treatment.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2009
- planned closingdate1-jun-2011
- Target number of participants37
- InterventionsObservational study with pharmacokinetic sampling.
- Primary outcomeRelationships between dextromethorphan clearance and the clearance of tamoxifen in breast cancer patients.
- Secondary outcomeRelationships 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.
- Timepoints1. Day -28/-1: informed consent;
2. Day 1: pharmaokinetic sampling (pre, 30 min-24hours in total 9 sampling time points).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Filip Vos, de
- CONTACT for SCIENTIFIC QUERIESMD PhD Ron H.J. Mathijssen
- Sponsor/Initiator Erasmus Medical Center - Daniel den Hoed Kliniek, afdeling Interne Oncologie
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center -Daniel den Hoed kliniek, afdeling Interne Oncologie
- Publicationsde Graan et al. Dextromethorphan as a phenotyping test to predict endoxifen exposure in patients on tamoxifen treatment. J Clin Oncol. 2011;29(24):6240-6
- Brief summaryIn this observational trial we would like to study the possible correlation between the probe-drug dextromethrophan and tamoxifen pharmacokinetics. In case a good correlation is available, this might help in a stepwise development of truly individualizing tamoxifen treatment. Study objectives are relationships between dextromethorphan clearance and the clearance of tamoxifen in breast cancer patients; 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. In one center (Erasmus Medical Center at Rotterdam, the netherlands), a total of 37 eligable patients, treated with a dose of 20 or 40 mg of tamoxifen, depending on their indication, will be given 30 mg dextromethorphan orally at day 1. Pharmacokinetic sampling will be performed at given time-points (pre, 30 min-24hours, in total 9 sampling time points). For dextromethorphan, blood samples will be processed to plasma and stored until analysis by a validated liquid chromatography tandem mass spectometry method. For tamoxifen, blood samples will be processed to serum and stored until analysis by a validated liquid chromatography tandem mass spectometry method.
- Main changes (audit trail)
- RECORD31-mrt-2009 - 12-okt-2016


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