At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Midazolam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Midazolam and Brigatinib for Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors. Completed, enrolled 24 participants across 14 sites in 4 countries.
Detailed Summary
The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors
CountriesFrance, Italy, Netherlands, Spain
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartJun 2019
Primary CompletionMar 2020
Study CompletionApr 2021
TodayJul 2026
First PostedFeb 5, 2018
Enrollment StartJun 26, 2019
Primary CompletionMar 24, 2020
Study CompletionApr 29, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.4 years ago
Interventions
Midazolamdrug
Midazolam syrup.
Brigatinibdrug
Brigatinib tablets.