Status:
COMPLETED
Pharmacokinetic Boosting of Osimertinib
Lead Sponsor:
Academisch Ziekenhuis Maastricht
Collaborating Sponsors:
The Netherlands Cancer Institute
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 t...
Detailed 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 b...
Eligibility Criteria
Inclusion
- 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 beyond progression, if treatment continuation is expected for multiple months. 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.
- 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.
- Patients with osimertinib plasma trough concentration below 195 ng/mL. Plasma trough concentration of osimertinib will be determined in another study (METC MUMC: 2018-0800).
Exclusion
- Any concurrent medication that is known to strongly inhibit or induce CYP3A4.
- Any concurrent medication that is primarily metabolized by CYP3A4 with a narrow therapeutic window.
- Impairment of gastrointestinal function that may alter the absorption of osimertinib or cobicistat (e.g. ulcerative disease, uncontrolled nausea or vomiting, malabsorption syndrome, small bowel resection).
- Refusing to refrain from consuming CYP3A4 influencing products, e.g. grapefruit(juice), St. John's wort.
- Pregnancy or breast feeding
- Child-Pugh score class C, chronic liver disease.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03858491
Start Date
November 1 2020
End Date
December 31 2021
Last Update
September 26 2022
Active Locations (2)
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1
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6225EC
2
Antoni van Leeuwenhoek hospital
Amsterdam, North Holland, Netherlands, 1066CX