Trial · NCT07485452
Boosting Osimertinib Blood Brain Barrier Penetration
NCT07485452, Phase 2, Recruiting, Maastricht University Medical Center
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Boosting Osimertinib Blood Brain Barrier Penetration. Trials, record NCT07485452. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07485452
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Boosting Osimertinib Blood Brain Barrier Penetration
- NCT number
- NCT07485452
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 7 participants, estimated
- Lead sponsor
- Maastricht University Medical Center
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Osimertinib & febuxostat
- First posted
- 2026-03-20
- Last updated
- 2026-06-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of combining osimertinib with febuxostat on osimertinib CSF:plasma ratio in patients with EGFR NSCLC without CNS metastases | 22-25 days after start of combination osimertinib + febuxostat | Determining the effect of combining osimertinib with the ABCG2 inhibitor febuxostat on osimertinib cerebrospinal fluid to plasma (CSF:plasma) concentration ratio, in patients with EGFR mutated NSCLC without central nervous system (CNS) metastases on brain MRI. Both CSF and plasma concentrations will be measured before and after combination of osimertinib with febuxostat. |
| Secondary | Effect on intracerebral osimertinib concentrations after combination with febuxostat | 22-25 days after start of concurrent treatment | Evaluating the extent by which febuxostat increases intracerebral osimertinib concentrations, by measuring osimertinib concentration in CSF before and after combination with febuxostat |
| Secondary | Effect on osimertinib plasma concentrations | 22-25 days after start of combined treatment | Assessing the effect of febuxostat on osimertinib plasma trough concentration in steady-state, by comparing concentrations before and after combination with febuxostat |
| Secondary | Plasma concentrations of AZ5104 and AZ7550 | 22-25 days after start of combined treatment | Assessing the effect of febuxostat on AZ5104 and AZ7550 (i.e. active metabolites of osimertinib) steady-state trough concentrations, by comparing concentrations before and after combined use. |
| Secondary | CSF concentrations of AZ5104 and AZ7550 | 22-25 days after start of combined treatment | Assessing the effect of febuxostat on AZ5104 and AZ7550 (i.e. active metabolites of osimertinib) concentrations in CSF, by comparing concentrations before and after combined use. |
| Secondary | Tolerability of osimertinib in combination with febuxostat | 22-25 days after start of combined treatment | Determining tolerability of osimertinib combined with febuxostat, by assessing adverse events according to CTCAE v5.0 criteria |
| Other | Effect ABCB1 and ABCG2 genotypes on osimertinib CNS exposure | 22-25 days after start combined therapy | Exploring potential effects of different ABCB1 and ABCG2 genotypes on CNS exposure of osimertinib and active metabolites AZ5104 and AZ7550 before and during combination with febuxostat. Therefore, it will be assessed whether variations in osimertinib concentrations (and concentrations of active metabolites) before and during combination with febuxostat may be explained by different ABCB1 and ABCG2 genotypes. |
| Other | Correlation between safety and osimertinib, AZ5104 and AZ7550 concentrations in blood and CSF | 22-25 days after start combination treatment | Exploring potential correlations between safety (AEs according to CTCAE v5.0) and osimertinib, AZ5104 and AZ7550 concentrations in blood and CSF |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07485452
GET https://conductscience.org/api/trials/v1/NCT07485452/registered