Pharmacokinetic Boosting of Osimertinib
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- STATUS
- Recruiting
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- End date
- Dec 31, 2021
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- participants needed
- 26
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- sponsor
- Academisch Ziekenhuis Maastricht
Summary
The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while receiving the standard osimertinib dose.
Description
Osimertinib is a new targeted agent registered for the treatment of patients with EGFR-mutated NSCLC. However, the costs of those new treatments are extremely high. Osimertinib is mainly metabolized by CYP3A4, and partially by CYP3A5. Combination of osimertinib with a strong CYP3A4-inhibitor may result in a smaller first-pass effect and a decreased clearance of osimertinib, thereby increasing the exposure to osimertinib.
Cobicistat is a strong CYP3A4-inhibitor, this mechanism may be used to boost osimertinib, as is done for other drugs, mainly drugs used to treat HIV-infected patients.
Using this personalized treatment approach and combining the concepts of therapeutic drug monitoring (TDM) and pharmacokinetic boosting, osimertinib therapy could become much more cost-effective. By reducing the necessary dose of osimertinib, this strategy may ultimately result in a significant reduction in drug costs, as the additional expenditure for the CYP3A4 inhibitor and blood sample analysis are negligible compared to the price of osimertinib.
Details
| Condition | Non-Small Cell Lung Cancer, nsclc |
|---|---|
| Treatment | Cobicistat |
| Clinical Study Identifier | NCT03858491 |
| Sponsor | Academisch Ziekenhuis Maastricht |
| Last Modified on | 27 January 2021 |
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