At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 4 enrolled
Drug / intervention
Osimertinib +1 moredrug
Likely dose
Osimertinib 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label PET Study to Determine Brain Exposure of Osimertinib After IV Microdose Administration of [11C]Osimertinib and Therapeutic Oral Doses of Osimertinib to Patients With EGFR Mutated NSCLC With Brain Metastases
In Brief
A Phase 1 clinical trial evaluating Osimertinib and [11C]osimertinib for Non-small Cell Lung Cancer. Completed, enrolled 4 participants across 1 site.
Detailed Summary
This is an open-label, single centre, Phase I study to determine the brain exposure of \[11C\]osimertinib in patients with EGFRm NSCLC with brain metastases.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesSweden
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 2018
Enrollment StartOct 2018
Primary CompletionMar 2020
Study CompletionOct 2020
TodayJul 2026
First PostedMar 13, 2018
Enrollment StartOct 24, 2018
Primary CompletionMar 19, 2020
Study CompletionOct 5, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.3 years ago
Interventions
Osimertinibdrug
Osimertinib 80 mg once daily p.o. will be taken continuously by the patient from the day of the second PET exam.
[11C]osimertinibdrug
Patients will receive 3 single IV microdose administrations of \[11C\]osimertinib and PET exams on: Day 1, Day 2 (or up to Day 8) and Day 29.