Actively Recruiting
Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat
Led by Maastricht University Medical Center · Updated on 2024-08-09
60
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess the feasibility of pharmacokinetically boosting osimertinib using cobicistat in order to improve osimertinib exposure in individual patients with advanced NSCLC (Non-Small Cell Lung Cancer) with mutated EGFR (Epidermal Growth Factor Receptor). The main questions it aims to answer are: * Cohort 1: Does concurrent use of osimertinib and cobicistat allow for osimertinib weekly intake reductions? If so, how much can the intake be reduced while retaining clinically effective exposure? * Cohort 2: Does concurrent use of osimertinib and cobicistat allow for improved penetration of osimertinib in the central nervous system, in patients with CNS (central nervous system) oligoprogression? Participants who are taking osimertinib in regular care will receive cobicistat in addition to their other medication. They will undergo blood sampling to measure the amount of osimertinib in blood, and measure the effect of boosting. Additionally, in cohort 1 patients will be dose-reduced if their exposure levels allow.
CONDITIONS
Official Title
Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is set to receive osimertinib 80 mg once daily as part of their standard treatment
- Patient has a World Health Organization Performance Status of 2 or lower
- Patient is 18 years or older
- Patient is able and willing to sign informed consent
- Patient is able and willing to undergo blood sampling
- For cohort 1: Non-squamous advanced EGFR-mutated NSCLC with no signs of imminent progression, or treatment deemed appropriate beyond progression
- For cohort 2: Non-squamous EGFR-mutated NSCLC with radiologically confirmed progressive but asymptomatic intracranial metastasis not in an eloquent brain area, and extracranial disease controlled
- Patient consents to blood analysis for CYP3A genotype
You will not qualify if you...
- Patient takes any drug known to strongly inhibit CYP3A4/CYP3A5 activity
- Patient takes any drug metabolized by CYP3A4/CYP3A5 with a small therapeutic window
- Patient takes any drug or product that may affect CYP3A4/CYP3A5 metabolism
- Patient has impaired gastrointestinal function
- Patient is pregnant or breastfeeding
- Patient has any contra-indication for cobicistat as listed in its product characteristics
AI-Screening
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Trial Site Locations
Total: 1 location
1
MaastrichtUMC
Maastricht, Limburg, Netherlands, 6229HX
Actively Recruiting
Research Team
P
Paul Kruithof, PharmD, MSc
CONTACT
S
Sander Croes, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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