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 range18 Years
SexALL
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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
✓. 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:
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
. 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