Pharmacokinetic boosting of osimertinib in patients with non-small cell lung cancer.

Completed

Conditions: lung carcinoma
lung cancer
10038666

Registration Number: NL-OMON55742

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 29

Inclusion Criteria

- Patients with EGFR-mutated NSCLC receiving standard treatment with
osimertinib for at least 2 months (steady-state) without any signs of disease
progression, or during treatment beyong progression, if treatment for another
couple of months is expected. After anticipated EMA approval of osimertinib
adjuvant therapy, patients on adjuvant osimertinib treatment may also
participate on the following conditions: if they are receiving standard
treatment with osimertinib for at least 2 months (steady-state), and if
treatment will be continued for a longer period than necessary for
participation in the OSIBOOST-trial.
- Patients with osimertinib plasma trough concentration below 195 ng/ml.
- Age * 18 years
- WHO performance status * 2.
- Able and willing to give written informed consent.
- Able and willing to undergo blood sampling for pharmacokinetic analysis.

Exclusion Criteria

- Any concurrent medication that is known to strongly inhibit or induce CYP3A4.
- Refusing to retain from consuming CYP3A4-influencing products, such as St
John's wort or grapefruitjuice).
- Pregnancy of breast feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter will be the change in exposure to osimertinib (i.e.<br /><br>AUC). The AUC of osimertinib will be measured at the start of the study (day 1)<br /><br>and after three weeks of co-treatment with cobicistat (day 22). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Cmax of osimertinib and the safety and tolerability of the combination<br /><br>therapy will serve as secundary outcomes. Additionally, we will evaluate the<br /><br>genotype of CYP3A4 and CYP3A5 for participating patients. </p><br>