The aim of this study is to show whether TDM leads to a lower proportion of patients with drug levels below the predefined TDM targets after 12 weeks
ID
Bron
Verkorte titel
Aandoening
Tyrosine kinase inhibitors
Oral anti-cancer drugs
Therapeutic drug monitoring
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
Therapeutic drug monitoring for oral anti-cancer drugs. In this study we measure drug levels of oral anti-cancer drugs 4, 8 and 12 weeks after treatment initiation and every 12 weeks thereafter. If the trough level of the drug is below the predefined target level of that drug and the patient does not show any treatment related ¡Ý grade 3 toxicity, the daily dose of the drug will be increased with one dose level or the advice can be given to take the drug concomitant with food.
Doel van het onderzoek
The aim of this study is to show whether TDM leads to a lower proportion of patients with drug levels below the predefined TDM targets after 12 weeks
Onderzoeksopzet
NA
Onderzoeksproduct en/of interventie
Doses will be increased in case of drug levels below the predefined TDM target and acceptable toxicity
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Indication to start treatment with anti-cancer drug from list (see section with list of participating drugs);
2. Age ¡Ý 18 years;
3. Able and willing to give written informed consent;
4. WHO performance status of 0, 1 or 2;
5. Able and willing to undergo blood sampling for PK analysis;
6. Life expectancy ¡Ý 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Woman who are pregnant or breast feeding;
2. Unreliable contraceptive methods;
3. Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair treatment compliance;
4. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the drug or puts the patient at high risk for treatment-related complications;
5. Legal incapacity.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6695 |
| NTR-old | NTR6866 |
| Ander register | (NKI-AVL study code) : M17TDM |