Therapeutic Drug Monitoring of BRAF- and MEK-inhibitors in a Real Life Cohort of Melanoma Patients

Therapeutic Drug Monitoring of BRAF- and MEK-inhibitors in a *Real Life* Cohort of Melanoma Patients - N12VDT: The BRAF- and MEK-inhibitor cohort study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38707

Enrollment

120

Registered

2013-05-24

Start date

2013-06-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

cancer malignancy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • All eligible patients (starting or already using) using vemurafenib, dabrafenib and/or trametinib for treatment of cancer. (Patients that are in a (sponsored) clinical trial that receive dabrafenib and/or trametinib will not be included, unless allowed by the other protocol); • Age 18 years or >18 years; • Patients from whom it is possible to collect blood samples; • Patients that are able and willing to undergo a finger prick for dried blood spot sampling; • Patients that are able and willing to give written informed consent;

Exclusion criteria

Exclusion criteria: The study objective is to monitor vemurafenib, dabrafenib and trametinib therapy in a *real life* cohort of patients. Therefore no strict exclusion criteria will be used.

Design outcomes

Primary

Measure	Time frame
To describe the PK variability in exposure to vemurafenib, dabrafenib and trametinib and relationship with treatment outcome (Radiological tumor assessments as per RECIST Version 1.1) and toxicity (graded on basis of the National Cancer Institute Common Toxicity grading Criteria for adverse events1 (CTC version 4.03)) in a real life cohort.	—

Secondary

Measure	Time frame
• To evaluate the specific influence of different parameters on variability in pharmacokinetics and -dynamics. -To identify the genotypes of drug metabolising enzymes and drug transporters to evaluate if these genotypes influence pharmacokinetics and - dynamics. -To identify drug metabolites, which might influence pharmacokinetics and -dynamics, and to elucidate the metabolic pathway(s). -To monitor the influence of food intake on the pharmacokinetics. -By quantification of the levels of vemurafenib and dabrafenib in skin and plasma samples, we will investigate the relationship between drug skin concentrations and the development of cutaneous squamous cell carcinoma (CSCC) as side effects. • To validate prospectively the methodology to measure vemurafenib, dabrafenib and trametinib levels in DBS.	—

Measure

Time frame

• To evaluate the specific influence of different parameters on variability in pharmacokinetics and -dynamics. -To identify the genotypes of drug metabolising enzymes and drug transporters to evaluate if these genotypes influence pharmacokinetics and - dynamics. -To identify drug metabolites, which might influence pharmacokinetics and -dynamics, and to elucidate the metabolic pathway(s). -To monitor the influence of food intake on the pharmacokinetics. -By quantification of the levels of vemurafenib and dabrafenib in skin and plasma samples, we will investigate the relationship between drug skin concentrations and the development of cutaneous squamous cell carcinoma (CSCC) as side effects. • To validate prospectively the methodology to measure vemurafenib, dabrafenib and trametinib levels in DBS.

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Countries

Netherlands

Outcome results