Therapeutic drug monitoring for oral anti-cancer drugs
Recruiting
- Conditions
- Tyrosine kinase inhibitorsOral anti-cancer drugsTherapeutic drug monitoring
- Registration Number
- NL-OMON21747
- Lead Sponsor
- The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
1. Indication to start treatment with anti-cancer drug from list (see section with list of participating drugs);
2. Age ¡Ý 18 years;
Exclusion Criteria
1. Woman who are pregnant or breast feeding;
2. Unreliable contraceptive methods;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To halve the proportion of patients with a drug exposure below TDM target level (historical case comparison) at the third moment of measuring after start of treatment (so after two moments of potential dose adjustment), for most compounds this will be after 12 weeks, except for compounds with intermittent dosing or a long half-life (see Appendix V of the full protocol for details on PK sampling per compound).
- Secondary Outcome Measures
Name Time Method Per drug:<br /><br>- To determine the safety and feasibility of PK guided dosing;<br /><br>- To determine the objective response rate (according to RECIST 1.1);<br /><br>- To determine the time to tumor progression and progression free survival;<br /><br>- To determine the proportion of patients with a drug exposure below TDM target level at the second moment of measuring (so after one moment of potential dose adjustment).<br /><br>All patients:<br /><br>- To have a physician adherence of >90% in following the provided patient tailored treatment recommendations which are based on the structured TDM program