Cancer, neoplasm
Conditions
Interventions
None listed
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Indication to start treatment with TKI which is mainly metabolised by CYP3A4; 2. Proven malignancy; 3. Age > 18 years; 4. Able and willing to give written informed consent; 5. WHO performance status of 0, 1 or 2; 6. Able and willing to undergo blood sampling for PK and genetic analysis;
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair treatment compliance; 3. Serious illness or medical unstable condition prohibiting adequate treatment and follow-up. 4. Unable or unwilling to stop the use of (over the counter) medication or (herbal) supplements which are known or suspected to strongly inhibit or induct the CYP3A4 enzymes;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with the usual dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare toxicity grades (based on CTCAE) between carriers and non-carriers - After pharmacokinetic assessment the dose may be adjusted based on clinical presentation and opinion of the treating clinician; incidence of dose modifications after four weeks will be compared using descriptive statistics between carriers and non-carriers. | — |
Contacts
Public ContactRuben van Eerden
Erasmus MC
Outcome results
None listed