Open-label PET Study With [11C]Osimertinib in Patients With EGFRm NSCLC and Brain Metastases

Sponsor
AstraZeneca
Study ID
NCT03463525
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib 80 mg once daily p.o. will be taken continuously by the patient from the day of the second PET exam.
  • [11C]osimertinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 24, 2018
Status verified
Apr 2022
Primary completion
Mar 19, 2020
Completion
Oct 5, 2020

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: [11C]osimertinib + oral osimertinib
    IV microdose administrations of \[11C\]osimertinib co-administered with 80 mg daily oral osimertinib.

Primary Outcome Measure

Maximum Concentration of Percent of Injected Dose in the Whole Brain (Cmax, %ID Brain) of [11C]Osimertinib [ Time Frame: Day 1, Day 2 (or up to Day 8) and Day 25 ]

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