Boosting Osimertinib Blood Brain Barrier Penetration

Sponsor
Maastricht University Medical Center
Study ID
NCT07485452
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib & febuxostat — DRUG
    Combining osimertinib with the ABCG2 inhibitor febuxostat to evaluate the effect on CSF concentrations of osimertinib

Study Details

The goal of this proof-of-concept clinical study is to determine the effect of combining osimertinib with febuxostat on cerebrospinal fluid concentrations of osimertinib in patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). The main question it aims to answer is: what is the effect of combining osimertinib with the ABCG2 inhibitor febuxostat on cerebrospinal fluid to unbound plasma osimertinib concentration ratio in patients with EGFR mutated NSCLC without central nervous system (CNS) metastases and without the ABCG2 34G\>A single nucleotide polymorphism (SNP)?

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
7 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combining osimertinib with febuxostat on cerebrospinal fluid concentration of osimertinib
    Determining the effect of combining osimertinib with ABCG2 inhibitor febuxostat on cerebrospinal fluid to unbound plasma osimertinib concentration ratio, in patients with EGFR mutated NSCLC without CNS metastases and without the ABCG2 34G\>A SNP

Primary Outcome Measure

Effect of combining osimertinib with febuxostat on osimertinib CSF:plasma ratio in patients with EGFR NSCLC without CNS metastases [ Time Frame: 22-25 days after start of combination osimertinib + febuxostat ]

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