← Back to Search

Tyrosine Kinase Inhibitor

Osimertinib + PET Imaging for Recurrent Glioblastoma

Phase 2

Waitlist Available

Led By Timothy Cloughesy

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation

5 half-lives or 4 weeks, whichever is greater, from any investigational (not FDA-approved) agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing how well a new cancer drug works with a new medical imaging technology to treat patients with a certain type of brain tumor.

Who is the study for?

This trial is for adults with a specific brain cancer called recurrent glioblastoma that has certain genetic features (EGFR activation without p53 mutation). Participants must have completed prior treatments within specified time frames, be able to take oral medication, and not be pregnant or breastfeeding. They should agree to use contraception and have a life expectancy of at least 12 weeks.Check my eligibility

What is being tested?

The study tests how well the drug Osimertinib works in stopping tumor growth by blocking enzymes needed for cell growth in patients with EGFR activated glioblastoma. It also uses an imaging technique called 18F-FDG PET to measure changes in glucose utilization by the tumors as an early indicator of the drug's effect.See study design

What are the potential side effects?

Potential side effects include issues related to heart rhythm, liver function abnormalities, low blood counts, lung problems like interstitial lung disease or pneumonitis requiring steroids, severe systemic diseases such as uncontrolled hypertension or active infections including hepatitis B/C and HIV.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had surgery for permanent sterilization, not including tubal ligation.

Select...

It's been over 4 weeks or 5 half-lives since I last took any experimental drugs.

Select...

It has been 3 weeks since my last non-nitrosourea chemotherapy.

Select...

My tumor shows EGFR activation based on specific tests.

Select...

My tumor does not have a p53 mutation.

Select...

I can care for myself but may need occasional help.

Select...

My MRI shows a tumor that is at least 1cm big.

Select...

It has been over 4 weeks since my last bevacizumab treatment.

Select...

I am over 50 and have not had a period for at least 12 months since stopping hormone treatments.

Select...

I have a high-grade brain tumor that has grown or come back after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in FDG uptake in tumor after short course exposure to osimertinib

Intrapatient variance of tumor fludeoxyglucose F-18 (FDG) uptake as determined by a double baseline FDG positron emission tomography (PET) prior to osimertinib exposure

Secondary outcome measures

Concentrations of osimertinib and metabolites AZ5104 and AZ7550 in post-dosing plasma samples.

Correlation between the reduction in glucose uptake and 6 months PFS

Incidence and severity of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (18F-FDG PET, osimertinib)Experimental Treatment3 Interventions

Within days -28 to -4, patients receive fludeoxyglucose F-18 IV and after 60 minutes undergo PET scan over 15 minutes. After 18-54 hours, patients undergo a second fludeoxyglucose F-18 PET scan. Patients then receive osimertinib PO QD on days -3 to -1 and after 24-72 hours, undergo a third fludeoxyglucose F-18 PET scan. Patients then receive osimertinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1010

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,063 Total Patients Enrolled

17 Trials studying Glioblastoma

514 Patients Enrolled for Glioblastoma

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,774 Total Patients Enrolled

14 Trials studying Glioblastoma

991 Patients Enrolled for Glioblastoma

Timothy CloughesyPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center

3 Previous Clinical Trials

38 Total Patients Enrolled

3 Trials studying Glioblastoma

38 Patients Enrolled for Glioblastoma

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03732352 — Phase 2

Glioblastoma Research Study Groups: Treatment (18F-FDG PET, osimertinib)

Glioblastoma Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03732352 — Phase 2

Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03732352 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Fludeoxyglucose F-18 an innocuous treatment method?

"The safety profile of Fludeoxyglucose F-18 is appraised to be a 2 due to the fact that this trial is in its second stage, with evidence suggesting it may have some protective properties but no reported efficacy."

Answered by AI

Is this research offering participants at the present time?

"Clinicaltrials.gov indicates that recruitment for this particular trial has closed, as the last update occurred on March 2nd 2022. Nonetheless, there are 1535 other trials which remain open and actively seeking participants."

Answered by AI

What therapeutic purpose does Fludeoxyglucose F-18 typically serve?

"Fludeoxyglucose F-18 is the usual go-to for treating left ventricular dysfunction, and can also provide benefit to those suffering from seizures, epilepsy, coronary artery disease (CAD), and cancer."

Answered by AI

How many participants are enrolled in this investigation?

"At this moment in time, patient recruitment for this medical trial has been suspended. It was originally posted to clinicaltrials.gov on November 28th 2018 and most recently updated on March 2nd 2022. Thankfully, there are numerous other studies recruiting; 1417 trials searching for glioblastoma patients and 118 seeking out participants with Fludeoxyglucose F-18 complications remain open."

Answered by AI

Is this experiment a novel one or has it been done before?

"Research into Fludeoxyglucose F-18 began in 2013, with an initial trial backed by AstraZeneca and involving 603 participants. Subsequently, the drug was approved for Phase 1 & 2 trials and today is under investigation at 118 locations across 1063 cities within 51 nations."

Answered by AI

What is the aim of this experimental endeavor?

"This clinical trial's primary objective will be to evaluate the change in Fluorodeoxyglucose (FDG) uptake after short-term exposure to osimertinib. Secondary outcomes include concentrations of osimertinib and its metabolites AZ5104 and AZ7550 within post-dosing plasma samples, which will be summarised with appropriate statistical measures. Moreover, a Kaplan–Meier curve will present descriptive data on Progression Free Survival (PFS), while a Receiver Operating Characteristic (ROC) analysis using leave one out cross validation techniques will investigate the correlation between reduced glucose uptake and 6 months PFS."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients With EGFR Activated Recurrent Glioblastoma

2018. "18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients With EGFR Activated Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03732352.

All > Recurrent Glioblastoma > Glioblastoma Multiforme