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

NCT03463525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-01-27

Study results available
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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.

Conditions

Interventions

DRUG

Osimertinib

Osimertinib 80 mg once daily p.o. will be taken continuously by the patient from the day of the second PET exam.

DRUG

[11C]osimertinib

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.

Sponsors & Collaborators

Principal Investigators

  • Simon Ekman, MD · Karolinska University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2020-03-19
Completion
2020-10-05

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463525 on ClinicalTrials.gov