Non-small Cell Lung CancerPhase 1ODIN-BMNCT03463525

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

A Phase 1 study testing Osimertinib and [11C]osimertinib in people with Non-small Cell Lung Cancer, run by AstraZeneca at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: Osimertinib and [11C]osimertinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteSweden
Study dates: 24 Oct 2018to 5 Oct 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. Procedures performed for routine clinical practice up to 2 weeks before the provision of written consent are acceptable if not intentionally done for study purposes.
If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study.
Male or female aged at least 18 years.
Histological or cytological confirmation of diagnosis of NSCLC.
Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR-TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or T790M EGFR resistance mutation as assessed by local laboratory/or central laboratory via tissue/cytology or in plasma.
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.

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In all patients enrolled, confirmed BM as having at least one non-measurable and/or measurable brain lesion at baseline as per CNS RECIST 1.1 via MRI imaging.
World Health Organisation (WHO) performance status 0 to 2 and a minimum life expectancy of 4 weeks.
Females should be using adequate contraceptive measures (up to 6 months after the last administration), should not be breastfeeding and must have a negative serum pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential by fulfilling 1 of the following criteria at screening:
Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
Women under 50 years old would be consider postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinising hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution.
Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
Male subjects should be willing to use barrier contraception
Have a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 inclusive and weigh at least 40.0 kg and no more than 100.0 kg, inclusive
Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.

Who cannot join

Participation in another clinical study with an IP during the previous 14 days (or longer, depending on characteristics of agents used).
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.
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting the IP with the exception of alopecia and grade 2, prior platinum therapy-related neuropathy.
History of brain surgery or major brain trauma in the last year (if the surgery is in the same hemisphere as the brain metastasis).
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or active infection including hepatitis B, hepatitis C and HIV.
Any of the following cardiac criteria:

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Mean resting corrected QT interval (QTc) >470 msec obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value.
Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block, second degree heart block).
Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including:
Serum/plasma potassium <lower limit of normal (LLN)
Serum/plasma magnesium <lower limit normal (LLN)
Serum/plasma calcium <lower limit normal (LLN)
Heart failure, 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 and cause Torsades de Pointes.
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
ANC <1.5 × 109/L; Platelets <100 × 109/L; Haemoglobin <90 g/L;
Alanine aminotransferase (ALT) >2.5x ULN or >5x ULN in the presence of liver metastases;
Aspartate aminotransferase (AST) >2.5x ULN or >5x ULN in the presence of liver metastases;
Total bilirubin >1.5x ULN or >3x ULN in the presence of liver metastases or Gilbert's Syndrome;
Creatinine >1.5xl ULN concurrent with creatinine clearance <50 mL/min (using Cockcroft-Gault formula).
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the tablet or previous significant bowel resection that would preclude adequate absorption of osimertinib.
History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
In addition, the following is considered a criterion for exclusion from the exploratory genetic research:
Previous allogenic bone marrow transplant
Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
Patients on anticoagulant treatment.
Absence of collateral flow between ulnar and radial artery as assessed by the Allen´s test".
Suffering from claustrophobia and/or having implanted metal devices or implants such as pacemaker, vascular or heart valves or metal deposits such as bullets, shells, metal grains in the eyes.
Previous participation in a research PET or PET/CT study.
The following are exclusion criteria for contrast enhanced MRIs:
Glomerular filtration rate <30 ml/min
History of renal insufficiency
Pregnancy
Women who are breast-feeding.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Research Site
Stockholm, SE 11 282

Other trials in Sweden

About this study

Official title: An Open-label PET Study to Determine Brain Exposure of Osimertinib After IV Microdose Administration of [11C]Osimertinib and Therapeutic Oral Doses of Osimertinib to Patients With EGFR Mutated NSCLC With Brain Metastases

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.

Read the detailed description

A Single-centre, Open-label, PET imaging and Pharmacokinetic Study of IV Administered [11C]osimertinib in EGFRm Non-small cell lung cancer patients with brain metastases. The study will consist of 2 phases, an imaging phase and a continuous access phase.

Conditions: Non-small Cell Lung Cancer
Being tested: Osimertinib, [11C]osimertinib
Keywords: Carcinoma, Non-Small-Cell Lung
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OsimertinibDrug
Also called Tagrisso, AZD9291
Osimertinib 80 mg once daily p.o. will be taken continuously by the patient from the day of the second PET exam.
[11C]osimertinibDrug
Also called [11C]AZD9291
Patients will receive 3 single IV microdose administrations of [11C]osimertinib and PET exams on: Day 1, Day 2 (or up to Day 8) and Day 29.

Study groups in NCT03463525
Study group	Role	What they receive
[11C]osimertinib + oral osimertinib	Experimental	IV microdose administrations of [11C]osimertinib co-administered with 80 mg daily oral osimertinib. Receives: Drug: Osimertinib; Drug: [11C]osimertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Concentration of Percent of Injected Dose in the Whole Brain (Cmax, %ID Brain) of [11C]Osimertinib
During the PET examination time, a series of arterial blood samples were taken to measure Cmax, %ID brain of [11C]osimertinib.
Measured: Day 1, Day 2 (or up to Day 8) and Day 25
Maximum Concentration of Brain Standardized Uptake Value (Cmax, SUV Brain) of [11C]Osimertinib
During the PET examination time, a series of arterial blood samples were taken to measure Cmax, SUV brain of [11C]osimertinib.
Measured: Day 1, Day 2 (or up to Day 8) and Day 25
Time of Maximum Radioactivity Concentration in the Brain (Tmax, Brain) of [11C]Osimertinib
The Tmax, brain was determined directly from the observed concentration versus time data.
Measured: Day 1, Day 2 (or up to Day 8) and Day 25
Brain to Plasma Partition Coefficient (Kp) of [11C]Osimertinib
The Kp was defined as ratio of radiolabeled drug in brain to that in plasma calculated as area under the brain radioactivity concentration-time curve between 0 and 90 minutes/area under the plasma radioactivity concentration-time curve between 0 and 90 minutes.
Measured: Day 1, Day 2 (or up to Day 8) and Day 25

Secondary outcomes (5)

Maximum Concentration at Steady State (Css,Max) of Osimertinib and Metabolite AZ5104
Venous blood samples were collected to determine Css,max of osimertinib and metabolite AZ5104.
Measured: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25
Time of Maximum Drug Concentration at Steady State (Tss,Max) of Osimertinib and Metabolite AZ5104
Venous blood samples were collected to determine tss,max of osimertinib and metabolite AZ5104.
Measured: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25
Area Under the Concentration-Time Curve at Steady State (AUCss) of Osimertinib and Metabolite AZ5104
Venous blood samples were collected to determine AUCss of osimertinib and metabolite AZ5104.
Measured: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25
Metabolite to Parent Ratio of AUCss
Venous blood samples were collected to determine AUCss of osimertinib and metabolite AZ5104.
Measured: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25
Metabolite to Parent Ratio of Css,Max
Venous blood samples were collected to determine Css,max of osimertinib and metabolite AZ5104.
Measured: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 20185 Oct 2020

First posted13 Mar 2018
Study start24 Oct 2018
Primary completion19 Mar 2020
Study completion5 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03463525
Sponsor's protocol ID: D5160C00043
Acronym: ODIN-BM
Status last verified: Apr 2022
First submitted: 20 Feb 2018
Last updated: 27 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label PET Study to Determine Brain Exposure of Osimertinib After IV Microdose Administration of [11C]Osimertinib and Therapeutic Oral Doses of Osimertinib to Patients With EGFR Mutated NSCLC With Brain Metastases
ClinicalTrials.gov ID: NCT03463525
Acronym / sponsor ID: ODIN-BM / D5160C00043
Conditions: Non-small Cell Lung Cancer
Keywords: Carcinoma, Non-Small-Cell Lung
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 24 Oct 2018 (actual)
Primary completion: 19 Mar 2020 (actual)
Study completion: 5 Oct 2020 (actual)
First posted: 13 Mar 2018 (actual)
Results: Posted 27 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[11C]osimertinib + oral osimertinib	Experimental	Drug: Osimertinib, Drug: [11C]osimertinibIV microdose administrations of [11C]osimertinib co-administered with 80 mg daily oral osimertinib.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. Procedures performed for routine clinical practice up to 2 weeks before the provision of written consent are acceptable if not intentionally done for study purposes.
If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study.
Male or female aged at least 18 years.
Histological or cytological confirmation of diagnosis of NSCLC.
Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR-TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or T790M EGFR resistance mutation as assessed by local laboratory/or central laboratory via tissue/cytology or in plasma.

Key exclusion criteria (34 listed)

Participation in another clinical study with an IP during the previous 14 days (or longer, depending on characteristics of agents used).
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.
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting the IP with the exception of alopecia and grade 2, prior platinum therapy-related neuropathy.
History of brain surgery or major brain trauma in the last year (if the surgery is in the same hemisphere as the brain metastasis).
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses or active infection including hepatitis B, hepatitis C and HIV.

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
OsimertinibAlso: Tagrisso, AZD9291Osimertinib 80 mg once daily p.o. will be taken continuously by the patient from the day of the second PET exam.	Drug	[11C]osimertinib + oral osimertinib
[11C]osimertinibAlso: [11C]AZD9291Patients will receive 3 single IV microdose administrations of [11C]osimertinib and PET exams on: Day 1, Day 2 (or up to Day 8) and Day 29.	Drug	[11C]osimertinib + oral osimertinib

Primary outcome

Maximum Concentration of Percent of Injected Dose in the Whole Brain (Cmax, %ID Brain) of [11C]Osimertinib
Time frame: Day 1, Day 2 (or up to Day 8) and Day 25
During the PET examination time, a series of arterial blood samples were taken to measure Cmax, %ID brain of [11C]osimertinib.
Maximum Concentration of Brain Standardized Uptake Value (Cmax, SUV Brain) of [11C]Osimertinib
Time frame: Day 1, Day 2 (or up to Day 8) and Day 25
During the PET examination time, a series of arterial blood samples were taken to measure Cmax, SUV brain of [11C]osimertinib.
Time of Maximum Radioactivity Concentration in the Brain (Tmax, Brain) of [11C]Osimertinib
Time frame: Day 1, Day 2 (or up to Day 8) and Day 25
The Tmax, brain was determined directly from the observed concentration versus time data.
Brain to Plasma Partition Coefficient (Kp) of [11C]Osimertinib
Time frame: Day 1, Day 2 (or up to Day 8) and Day 25
The Kp was defined as ratio of radiolabeled drug in brain to that in plasma calculated as area under the brain radioactivity concentration-time curve between 0 and 90 minutes/area under the plasma radioactivity concentration-time curve between 0 and 90 minutes.

5 secondary outcomes

Maximum Concentration at Steady State (Css,Max) of Osimertinib and Metabolite AZ5104
Time frame: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25
Time of Maximum Drug Concentration at Steady State (Tss,Max) of Osimertinib and Metabolite AZ5104
Time frame: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25
Area Under the Concentration-Time Curve at Steady State (AUCss) of Osimertinib and Metabolite AZ5104
Time frame: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25
Metabolite to Parent Ratio of AUCss
Time frame: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25
Metabolite to Parent Ratio of Css,Max
Time frame: Pre-dose and 2, 4 and 7.5 hours postdose on Day 25

Results and safety

Results posted to the registry on 27 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	4	4

Primary outcome: Maximum Concentration of Percent of Injected Dose in the Whole Brain (Cmax, %ID Brain) of [11C]Osimertinib

Time frame: Day 1, Day 2 (or up to Day 8) and Day 25. Geometric mean (Geometric Coefficient of Variation). Unit: percent of radioactive drug

Measure	All Participants n = 4
Day 1: PET1	1.465 (9.6)
Day 2 (or up to Day 8): PET2	1.617 (6.6)
Day 25: PET3	1.492 (15.1)

Population analysed: The PET analysis set included all participants who completed at least one PET examination for the evaluation of \[11C\]osimertinib brain distribution.

Primary outcome: Maximum Concentration of Brain Standardized Uptake Value (Cmax, SUV Brain) of [11C]Osimertinib

Time frame: Day 1, Day 2 (or up to Day 8) and Day 25. Geometric mean (Geometric Coefficient of Variation). Unit: SUV

Measure	All Participants n = 4
Day 1: PET1	1.006 (27.1)
Day 2 (or up to Day 8): PET2	1.111 (22.0)
Day 25: PET3	1.054 (29.1)

Population analysed: The PET analysis set included all participants who completed at least one PET examination for the evaluation of \[11C\]osimertinib brain distribution.

Primary outcome: Time of Maximum Radioactivity Concentration in the Brain (Tmax, Brain) of [11C]Osimertinib

Time frame: Day 1, Day 2 (or up to Day 8) and Day 25. Median (Full Range). Unit: minutes

Measure	All Participants n = 4
Day 1: PET1	22.160 (10.67 to 42.23)
Day 2 (or up to Day 8): PET2	36.340 (8.83 to 78.25)
Day 25: PET3	37.125 (16.83 to 60.30)

Population analysed: The PET analysis set included all participants who completed at least one PET examination for the evaluation of \[11C\]osimertinib brain distribution.

Primary outcome: Brain to Plasma Partition Coefficient (Kp) of [11C]Osimertinib

Time frame: Day 1, Day 2 (or up to Day 8) and Day 25. Mean (Standard Deviation). Unit: ratio

Measure	All Participants n = 4
Day 1: PET1	3.753 (0.8328)
Day 2 (or up to Day 8): PET2	3.960 (0.9413)
Day 25: PET3	4.658 (1.5362)

Population analysed: The PET analysis set included all participants who completed at least one PET examination for the evaluation of \[11C\]osimertinib brain distribution.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the first dose administration of study drug (Day 1) up to 30 days after last dose administration of study drug, approximately 55 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Limitations and caveats (from the sponsor): The COVID-19 pandemic resulted in recruitment being put on hold due to the PET center closing. The Global Study Team endorsed the decision to have fewer participants than anticipated. Participants enrolled in the study continued as planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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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.

Simon Ekman, MD principal investigator

Karolinska University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Osimertinib and [11C]osimertinib in people with Non-small Cell Lung Cancer, run by AstraZeneca at 1 site in Sweden.

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 15 inclusion and 34 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 27 Jan 2023. 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 Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Concentration of Percent of Injected Dose in the Whole Brain (Cmax, %ID Brain) of [11C]Osimertinib (time frame: Day 1, Day 2 (or up to Day 8) and Day 25). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03463525.

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 27 Jan 2023.