Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Patients must be able to provide written informed consent - Patients must have histologically proven World Health Organization (WHO) grade IV glioblastoma who have supratentorial contrast enhancing progressive or recurrent tumor by MRI imaging following standard or experimental treatment.
- - Patients must have measurable contrast enhancing disease with a measurement of at least 1 x 1 x 1 cm using MRI contrast imaging - Patients must have recovered from severe toxicity of prior therapy.
- - 12 weeks from the completion of radiation - 6 weeks from a nitrosourea chemotherapy - 3 weeks from a non-nitrosourea chemotherapy - 4 weeks from any Food and Drug Administration (FDA) approved agents - 5 half-lives or 4 weeks, whichever is greater, from any investigational (not FDA-approved) agents - 4 weeks from the last treatment with bevacizumab - 2 weeks from administration of a non-cytotoxic, FDA-approved agent other than bevacizumab (e.g., hydroxychloroquine, etc.) - Patient tumor sample must have evidence of EGFR activation as determined by EGFR amplification and/or EGFR mutations by fluorescent in situ hybridization (FISH) or sequencing approaches - Patient tumor sample must not have p53 mutation - Note: Patients will be enrolled based on the documented EGFR/p53 status from the previous assays completed locally.
- - Patients must have a Karnofsky performance status (KPS) >= 60 - Patients must have a life expectancy >= 12 weeks - Patients must be able to swallow medication by mouth - Women of childbearing potential must have a negative serum pregnancy test prior to study entry.
Exclusion Criteria:- Involvement in the planning and/or conduct of the study - Previous enrollment in the present study or previous treatment with osimertinib - Prior exposure to EGFR targeted therapy - Currently receiving any other investigational agents - Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks prior) - Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy? related neuropathy - Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator?s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV) - 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 - Any of the following cardiac criteria: - Mean resting corrected QT interval (QTc) > 470 msec obtained from an electrocardiogram (ECG), using the screening clinic ECG machine derived QTc value - Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval - Absolute neutrophil count < 1.5 x 10^9/L - Platelet count < 100 x 10^9/L - Hemoglobin < 90 g/L - 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 - Aspartate aminotransferase > 2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases - Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of documented Gilbert?s syndrome (unconjugated hyperbilirubinemia) or liver metastases - Serum creatinine > 1.5 times ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation)?confirmation of creatinine clearance is only required when creatinine is > 1.5 times ULN - History of hypersensitivity active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib - Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease - Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Jonsson Comprehensive Cancer Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||UCLA / Jonsson Comprehensive Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|EGFR Gene Amplification, EGFR Gene Mutation, Glioblastoma, Recurrent Glioblastoma, Supratentorial Glioblastoma, TP53 wt Allele|
- I. Define the test - retest variance of tumor fludeoxyglucose (FDG) uptake using double baseline 18F-FDG PET imaging (18 to 54 hours apart) in patients with EGFR activated recurrent glioblastoma.
- II. After defining #1, evaluate whether osimertinib can create a statistically significant decrease in glucose utilization as determined using early, post dosing (24-72 hour) FDG-PET imaging in patients with EGFR activated recurrent glioblastoma.
- I. Safety and tolerability of osimertinib in this patient population.
- II. Determine clinical effect of osimertinib in this patient population, as determined by 6 months progression-free survival.
- III. Correlated clinical effect of osimertinib with FDG-PET results in this patient population, to define by receiver operating characteristic (ROC) analysis a clinically meaningful decrease in glucose utilization, which correlates with the clinical effect.
- IV. Evaluate pharmacokinetic (PK) in this patient population using spot PK during imaging and at set time points during the study.
Experimental: Treatment (18F-FDG PET, osimertinib)
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.
Other: - Fludeoxyglucose F-18
Drug: - Osimertinib
Procedure: - Positron Emission Tomography
Undergo fludeoxyglucose F-18 PET scan
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.