A Drug-drug Interaction Study of Avapritinib and Midazolam (NCT04908176) | Clinical Trial Compass
CompletedPhase 1
A Drug-drug Interaction Study of Avapritinib and Midazolam
United States10 participantsStarted 2022-08-24
Plain-language summary
The purpose of this study is to investigate the effect of multiple dosing of avapritinib on the pharmacokinetics (PK) of midazolam in adult patients with metastatic or unresectable gastrointestinal stromal tumors (GIST), recurrent gliomas, or other KIT mutant tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be ≥18 years of age at the time of signing the informed consent
. Confirmed diagnosis of
--Non-resectable advance solid tumor with KIT mutation with progression following standard of care treatment.
--Confirmed diagnosis of recurrent or unresectable CNS tumors including :IDH-mutant astrocytoma, IDH-mutant oligodendroglioma, glioblastoma, H3K27-altered diffuse midline glioma, H3G34-mutant diffuse hemispheric glioma, midline glioma (with unknown H3K27 mutation status) that has failed prior radiation or systemic SOC therapy.
. Must be able to swallow an oral medication
. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
maximum plasma concentration (Cmax) of midazolam
Timeframe: Day 1 and Day 18
2
time of maximum plasma concentration (tmax) of midazolam
Timeframe: Day 1 and Day 18
3
area under the plasma concentration-time curve (AUC) of midazolam
. Patient agrees to use contraception consistent with local regulations
. Must provide signed informed consent to participate in the study
Exclusion criteria
. Patients with GIST that harbors a known PDGFRA mutation
. Known hypersensitivity to avapritinib, midazolam, or any of their excipients
. Have received previous therapy with avapritinib
. Have any of the following laboratory abnormalities before the first dose of study drug:
. Require therapy with a concomitant medication that is a strong and moderate CYP3A4 inhibitors or inducers
. Consumption of any nutrients known to modulate CYP3A4 enzymes activity (eg, grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville \[blood\] orange and derivative products, cruciferous vegetables \[eg, broccoli, cauliflower, cabbage, brussel sprouts\]) within 14 days before screening and during the study until the end of the Main Treatment Period
. Have received a prior anticancer drug less than 5 half-lives or 14 days (whichever is shorter) before screening
. Have had a major surgical procedure within 14 days of the first dose of study drug or have significant traumatic injury within 28 days before screening