Clinical Trial · NCT03463525

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

Overview

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.

Sponsor

AstraZeneca

Phase

Phase 1

Contacts

Simon Ekman, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03463525

Eligibility

Inclusion

Alanine aminotransferase (ALT) \>2.5x ULN or \>5x ULN in the presence of liver metastases;
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
Serum/plasma calcium \<lower limit normal (LLN)
Histological or cytological confirmation of diagnosis of NSCLC.
Previous participation in a research PET or PET/CT study.
Serum/plasma potassium \<lower limit of normal (LLN)
Glomerular filtration rate \<30 ml/min
Mean resting corrected QT interval (QTc) \>470 msec obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value.
Creatinine \>1.5xl ULN concurrent with creatinine clearance \<50 mL/min (using Cockcroft-Gault formula).
Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including:
Previous allogenic bone marrow transplant
Patients on anticoagulant treatment.
Treatment with any of the following: EGFR-TKI (e.g. erlotinib, gefitinib or afatinib) within 10 days or at least 5x the half-life, whichever is the longer; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within 14 days of start of IP; osimertinib in the present or other studies; major surgery (excluding placement of vascular access) within 4 weeks of start of IP; radiotherapy (including brain) with a limited field of radiation within 1 week of start of IP, except in patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first administration of the IP; current receipt (or inability to stop at least 3 weeks before study start) medications or herbal supplements known to be potent inducers of CYP3A4.
World Health Organisation (WHO) performance status 0 to 2 and a minimum life expectancy of 4 weeks.
Mandatory provision (if available) of formalin fixed, paraffin embedded tissue and blood for central confirmation of EGFR mutation status. Please refer to the Laboratory Manual for details.

Exclusion

Absence of collateral flow between ulnar and radial artery as assessed by the Allen´s test".