Boosting Osimertinib Blood Brain Barrier Penetration
ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center
About this trial
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)?
Eligibility criteria
Qualifiers
The patient has metastatic EGFR-mutated NSCLC and is treated with osimertinib as part of regular care with CT-confirmed stable disease or better. Patients with (signs of) disease progression, are also eligible if their treating physician deems the treatment to be appropriate beyond progression and the expected osimertinib treatment duration is at least 1 month.
The patient has an European Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
The patient is 18 years of age or older.
The patient is able and willing to sign informed consent prior to any tests or procedures.
Disqualifiers
The patient has an acute gout attack, and medical history of gout or xanthinuria
The patient uses urate-lowering agents, azathioprine, 6-mercaptopurine, tioguanine
The patient uses potent inducers of UDP-glucuronosyltransferase (UGT) enzymes, such as rifampicin and carbamazepine
The patient uses prohibited co-medication: drugs that moderately or strongly inhibits or induces CYP3A4 or P-glycoprotein (P-gp)
Trial design
Treatments tested in this trial
- Osimertinib & febuxostat
Treatment groups
7 Participants
are divided into 1 treatment groupSponsors and collaborators
Maastricht University Medical Center
Lead sponsor
AstraZeneca
Collaborator
The Netherlands Cancer Institute
Collaborator
Source ClinicalTrials.gov