EGFR Gene AmplificationPhase 2NCT03732352
18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients with EGFR Activated Recurrent Glioblastoma
A Phase 2 study testing Fludeoxyglucose F-18, Osimertinib and Positron Emission Tomography in people with EGFR Gene Amplification and EGFR Gene Mutation, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and osimertinib works in evaluating glucose utilization in patients with EGFR activated glioblastoma. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Gene Amplification, EGFR Gene Mutation, Glioblastoma
- What is being tested?
- Fludeoxyglucose F-18, Osimertinib and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 31 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. The following intervals from previous treatments are required to be eligible:
- 12 weeks from the completion of radiation
- 6 weeks from a nitrosourea chemotherapy
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- 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. If post enrollment evaluation of the archival tissue revealed that neither EGFR amplification nor EGFR mutations were present by using FISH or next generation sequencing, or mutant p53 by exon sequencing, the patients may continue their participation in the study. The investigator should discuss with patients regarding their willingness of continuation of participation in the study
- 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. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for the institution
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of osimertinib administration
- Provision of informed consent for genetic research
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Creating Metabolic Vulnerabilities in Patients with EGFR Activated Recurrent Glioblastoma by Inhibiting EGFR with Osimertinib
This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and osimertinib works in evaluating glucose utilization in patients with EGFR activated glioblastoma. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 18F-FDG PET imaging may help to detect changes in tumor glucose utilization, which may allow investigators to obtain an early read out on the impact of osimertinib on recurrent glioblastoma patients whose tumors have EGFR activation.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
SECONDARY OBJECTIVES:
- 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.
OUTLINE:
Within days -28 to -4, patients receive fludeoxyglucose F-18 intravenously (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 orally (PO) once daily (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.
After completion of study treatment, patients are followed up at 30 days and then every 2 months thereafter.
- Conditions
- EGFR Gene Amplification, EGFR Gene Mutation, Glioblastoma, Recurrent Glioblastoma, Supratentorial Glioblastoma, TP53 Wt Allele
- Being tested
- Fludeoxyglucose F-18, Osimertinib, Positron Emission Tomography
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludeoxyglucose F-18Other
Also called 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18
Given IV
OsimertinibDrug
Also called AZD-9291, AZD9291, Mereletinib, Tagrisso
Given PO
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo fludeoxyglucose F-18 PET scan
| Study group | Role | What they receive |
|---|---|---|
| Treatment (18F-FDG PET, osimertinib) | Experimental | 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. Receives: Other: Fludeoxyglucose F-18; Drug: Osimertinib; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapatient variance of tumor fludeoxyglucose F-18 (FDG) uptake as determined by a double baseline FDG positron emission tomography (PET) prior to osimertinib exposure
Test-retest variances in FDG uptake will be estimated considering the variance of sample specific differences between first and second PET scans. This variance component will be estimated using a Bayesian conjugate analysis of Gaussian variates. Model adequacy diagnostics will compare predictive distributions to the observed data via posterior predictive assessment. Bayesian (95%) high posterior density intervals, and Bayesian posterior means will be used as the basis for statistical inference.
Measured: At baseline
Change in FDG uptake in tumor after short course exposure to osimertinib
In order to estimate the difference in FDG tumor uptake between pre and post exposure to osimertinib, a simple change model will be considered, comparing the mean baseline uptake with the mean uptake, after treatment. A formal test for difference in mean will be based on a paired T statistic for difference in mean. 95% confidence intervals will be used to quantify uncertainty in estimation.
Measured: Baseline to day -1
Secondary outcomes (4)
Incidence and severity of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
All events will be recorded from the time a subject has signed the Informed Consent Form. AE analyses will include only treatment emergent adverse events. Specifically, following quantities will be estimated: incidence (number [no.] of patients) and frequency (no. of events) overall and broken down by System Organ Classification and incidence (no. of patients) and frequency (no. of events) broken down by severity.
Measured: Up to 2 years
Percentage of participants surviving 6 months from the start of study treatment without progression of disease determined by progression free survival (PFS) according to Response Assessment in Neuro-oncology criteria
Will be based on the sampling distribution of a simple binomial proportion. Additionally, descriptive data will be provided for the duration of PFS as a Kaplan-Meier curve.
Measured: From the date of study treatment initiation to the date of the first documented progression or to death due to any cause, assessed up to 6 months
Correlation between the reduction in glucose uptake and 6 months PFS
Reduction in glucose uptake will be correlated with clinical outcome-- 6 months PFS, receiver operating characteristic curve (ROC) analyses of simple thresholding strategies will be performed using leave one out cross validation.
Measured: Up to 2 years
Concentrations of osimertinib and metabolites AZ5104 and AZ7550 in post-dosing plasma samples.
PK concentration data will be summarized using appropriate summary statistics
Measured: At the end of Cycle 1 (each cycle is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start28 Nov 2018
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Gene AmplificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Timothy Cloughesy, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732352
- Sponsor's protocol ID
- 18-001000
- Other IDs
- NCI-2018-02010
- Status last verified
- Nov 2024
- First submitted
- 15 Oct 2018
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Metabolic Vulnerabilities in Patients with EGFR Activated Recurrent Glioblastoma by Inhibiting EGFR with Osimertinib
- ClinicalTrials.gov ID
- NCT03732352
- Acronym / sponsor ID
- 18-001000
- Conditions
- EGFR Gene Amplification, EGFR Gene Mutation, Glioblastoma, Recurrent Glioblastoma, Supratentorial Glioblastoma, TP53 Wt Allele
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and osimertinib works in evaluating glucose utilization in patients with EGFR activated glioblastoma. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 18F-FDG PET imaging may help to detect changes in tumor glucose utilization, which may allow investigators to obtain an early read out on the impact of osimertinib on recurrent glioblastoma patients whose tumors have EGFR activation.
Detailed description
PRIMARY OBJECTIVES:
- 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.
SECONDARY OBJECTIVES:
- 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.
OUTLINE:
Within days -28 to -4, patients receive fludeoxyglucose F-18 intravenously (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 orally (PO) once daily (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.
After completion of study treatment, patients are followed up at 30 days and then every 2 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (18F-FDG PET, osimertinib) | Experimental | Other: Fludeoxyglucose F-18, Drug: Osimertinib, Procedure: Positron Emission TomographyWithin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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. The following intervals from previous treatments are required to be eligible:
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fludeoxyglucose F-18Also: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18Given IV | Other | Treatment (18F-FDG PET, osimertinib) |
| OsimertinibAlso: AZD-9291, AZD9291, Mereletinib, TagrissoGiven PO | Drug | Treatment (18F-FDG PET, osimertinib) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo fludeoxyglucose F-18 PET scan | Procedure or surgery | Treatment (18F-FDG PET, osimertinib) |
Primary outcome
Intrapatient variance of tumor fludeoxyglucose F-18 (FDG) uptake as determined by a double baseline FDG positron emission tomography (PET) prior to osimertinib exposure
Time frame: At baseline
Test-retest variances in FDG uptake will be estimated considering the variance of sample specific differences between first and second PET scans. This variance component will be estimated using a Bayesian conjugate analysis of Gaussian variates. Model adequacy diagnostics will compare predictive distributions to the observed data via posterior predictive assessment. Bayesian (95%) high posterior density intervals, and Bayesian posterior means will be used as the basis for statistical inference.
Change in FDG uptake in tumor after short course exposure to osimertinib
Time frame: Baseline to day -1
In order to estimate the difference in FDG tumor uptake between pre and post exposure to osimertinib, a simple change model will be considered, comparing the mean baseline uptake with the mean uptake, after treatment. A formal test for difference in mean will be based on a paired T statistic for difference in mean. 95% confidence intervals will be used to quantify uncertainty in estimation.
4 secondary outcomes
Incidence and severity of adverse events (AEs) assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time frame: Up to 2 years
Percentage of participants surviving 6 months from the start of study treatment without progression of disease determined by progression free survival (PFS) according to Response Assessment in Neuro-oncology criteria
Time frame: From the date of study treatment initiation to the date of the first documented progression or to death due to any cause, assessed up to 6 months
Correlation between the reduction in glucose uptake and 6 months PFS
Time frame: Up to 2 years
Concentrations of osimertinib and metabolites AZ5104 and AZ7550 in post-dosing plasma samples.
Time frame: At the end of Cycle 1 (each cycle is 28 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Cloughesy principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludeoxyglucose F-18, Osimertinib and Positron Emission Tomography in people with EGFR Gene Amplification and EGFR Gene Mutation, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrapatient variance of tumor fludeoxyglucose F-18 (FDG) uptake as determined by a double baseline FDG positron emission tomography (PET) prior to osimertinib exposure (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.