Therapeutic drug monitoring for oral anti-cancer drugs

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21747

Enrollment

600

Registered

2017-12-06

Start date

2017-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tyrosine kinase inhibitors Oral anti-cancer drugs Therapeutic drug monitoring

Interventions

Doses will be increased in case of drug levels below the predefined TDM target and acceptable toxicity

Eligibility

Inclusion criteria

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; 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
Per 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	—

Measure

Time frame

Per 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

—

Contacts

Public ContactSteffie Groenland

NKI

s.groenland@nki.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)