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Therapeutic drug monitoring for oral anti-cancer drugs


- candidate number28307
- NTR NumberNTR6866
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-dec-2017
- Secondary IDsM17TDM  (NKI-AVL study code)
- Public TitleTherapeutic drug monitoring for oral anti-cancer drugs
- Scientific TitleTherapeutic drug monitoring for oral anti-cancer drugs
- ACRONYMM17TDM
- hypothesisThe 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
- Healt Condition(s) or Problem(s) studiedTyrosine kinase inhibitors, Oral anti-cancer drugs, Therapeutic drug monitoring
- Inclusion criteria1. Indication to start treatment with anti-cancer drug from list (see section with list of participating drugs);
2. Age 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 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity.
- Exclusion criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate1-jun-2019
- Target number of participants600
- InterventionsDoses will be increased in case of drug levels below the predefined TDM target and acceptable toxicity
- Primary outcomeTo 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 outcomePer drug:
- To determine the safety and feasibility of PK guided dosing;
- To determine the objective response rate (according to RECIST 1.1);
- To determine the time to tumor progression and progression free survival;
- 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).
All patients:
- To have a physician adherence of >90% in following the provided patient tailored treatment recommendations which are based on the structured TDM program
- TimepointsNA
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Steffie Groenland
- CONTACT for SCIENTIFIC QUERIES Steffie Groenland
- Sponsor/Initiator The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Funding
(Source(s) of Monetary or Material Support)
Roche, Novartis, Pfizer
- Publications
- Brief summaryTherapeutic 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 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.
- Main changes (audit trail)
- RECORD6-dec-2017 - 15-dec-2017


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