Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04051827) enrolled 26 participants who received both midazolam (a medicine commonly used as a sedative) and mobocertinib (a cancer medicine). The trial was designed to measure how the presence of mobocertinib in the body affects the way midazolam is absorbed and processed — in other words, whether taking the two medicines together changes how midazolam behaves in the bloodstream compared with taking it alone. Notably, the reported data shows that none of the 26 participants were recorded as having "completed" the study, with all 26 listed under "not completed," though no further explanation for this is provided in the submitted data. The reported data shows results for several blood-level measurements of midazolam. When midazolam was taken by mouth alone, the peak blood concentration (the highest level measured in the blood) was reported as 17.0 ng/mL, compared with 17.5 ng/mL when taken alongside mobocertinib. The total exposure to midazolam over time (a measure of how much of the medicine the body absorbed overall) was reported as 58.3 ng·h/mL when taken alone, and 39.0 ng·h/mL when taken with mobocertinib. For midazolam given directly into a vein, the peak blood concentration was 70.8 ng/mL alone versus 92.2 ng/mL with mobocertinib, and the total exposure was 90.4 ng·h/mL alone versus 71.6 ng·h/mL with mobocertinib. The time it took for midazolam to reach its peak level in the blood was reported as approximately 0.52 hours (oral) and 0.05 hours (intravenous) under both conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Lung Cancer Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You have been diagnosed with non-small cell lung cancer (NSCLC) that is locally advanced, has come back, or has spread to other parts of the body (Stage IV), and surgery or radiation as a main treatment is not an option for you.
- Your cancer has stopped responding to, or you could not tolerate, the standard treatments available to you.
- You are generally able to carry out light activity and care for yourself (your doctor will assess this using a standard scale).
- Your doctors expect you to live for at least 3 more months.
- Your liver is working well enough, based on specific blood test results (confirm with trial site).
- Your kidneys are working well enough, based on a specific blood test result (confirm with trial site).
- Your blood protein (albumin) levels and pancreas enzyme levels are within an acceptable range (confirm with trial site).
- Your bone marrow is producing enough blood cells, including white blood cells, platelets, and red blood cells, shown by blood tests (confirm with trial site).
- Your heart's electrical activity is within a normal range, shown by a heart tracing (ECG) test.
- Any side effects from previous cancer treatments have mostly cleared up before starting this trial.
- You have suitable veins for blood samples to be taken during the study.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have taken certain medications that strongly affect how the body processes drugs (CYP3A inhibitors or inducers) within the last 2 weeks (confirm with trial site).
- You have received other small-molecule cancer treatments or experimental drugs within the last 2 weeks.
- You have received certain cancer-fighting antibody treatments (such as immunotherapy checkpoint inhibitors) within the last 28 days.
- You have had radiotherapy within the last 14 days, with some exceptions for certain targeted or palliative radiation types given more than 7 days ago (confirm with trial site).
- You have had major surgery within the last 28 days (minor procedures like biopsies are generally acceptable).
- You have been diagnosed with another type of cancer, unless it was certain limited types that have been fully treated (such as some skin cancers, cervical cancer in situ, prostate cancer, or another cancer you have been free of for at least 3 years).
- You have active or growing tumours in your brain that are untreated or getting worse (stable, previously treated brain tumours that do not require steroid medication may be acceptable — confirm with trial site).
- You currently have cancer pressing on your spinal cord or cancer spread to the lining around the brain or spinal cord.
- You have high blood pressure that is not being controlled with treatment.
- You have had a serious heart condition in the past 6 months, such as a heart attack, heart failure, unstable chest pain, a stroke, or certain heart rhythm problems.
- You are taking medications known to cause a specific dangerous heart rhythm problem called torsades de pointes (confirm with trial site).
- You have a stomach or bowel condition that might stop you from properly absorbing the trial medication taken by mouth.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 4 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Part A, Cmax: Geometric Mean Maximum Observed Plasma Concentration (Cmax) for Midazolam Administered Orally With Mobocertinib (Cycle 1 Day 24) and Without Mobocertinib (Cycle 1 Day 1); Part A, AUC∞: Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam Administered Orally With Mobocertinib (Cycle 1 Day 24) and Without Mobocertinib (Cycle 1 Day 1); Part A, Cmax: Geometric Mean Maximum Observed Plasma Concentration (Cmax) for Midazolam Administered Intravenously With Mobocertinib (Cycle 1 Day 25) and Without Mobocertinib (Cycle 1 Day 2); Part A, AUC∞...
Other options
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.