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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

Must not have

Alanine aminotransferase > 2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases

Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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

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

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My tumor shows EGFR activation based on specific tests.

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My tumor does not have a p53 mutation.

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I can care for myself but may need occasional help.

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver enzyme levels are higher than normal due to my cancer.

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I cannot take pills due to severe nausea, vomiting, gut diseases, or major bowel surgery.

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My bilirubin levels are higher than normal, but it's due to my condition.

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I am allergic to osimertinib or similar drugs.

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I have had lung conditions that needed steroid treatment.

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I have been treated with drugs targeting EGFR before.

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I have not been in this study or treated with osimertinib before.

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I have a heart condition.

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I am taking or can't stop taking certain medications or supplements that affect my liver enzymes.

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My liver enzyme levels are higher than normal due to my cancer.

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I have conditions or take medications that could affect my heart's rhythm.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1100

Positron Emission Tomography

2011

Completed Phase 2

~2200