A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors

Completed

• Conditions: solid tumor; tumor that develops in an organ; 10027656

• Registration Number: NL-OMON48899
• Lead Sponsor: ARIAD wholly owned subsidiary of Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

1. Locally advanced or metastatic solid tumors who meet 1 of the following 4 criteria:;-With locally advanced or metastatic ALK-positive NSCLC who have progressed on or are intolerant to treatment with at least 1 other ALK inhibitor.;-With ALK-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.;-With locally advanced or metastatic ROS1-positive NSCLC who have progressed on crizotinib therapy or are intolerant to crizotinib, or;-With ROS1-positive nonlung solid tumors that are locally advanced or metastatic and for whom no standard, nonexperimental therapy is available.;2. Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.;3. Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.;4. Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03 Grade less than or equal to (<<=) 1.;5. Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).

Exclusion Criteria

1. Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.;2. Prior therapy with brigatinib.;3. Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.;4. Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.;5. Received chemotherapy or radiation therapy within 14 days before the first dose of study drug, except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.;6. Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.;7. Had major surgery within 30 days before the first dose of study drug. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.;8. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoints and Assessments:<br /><br>* Primary: Midazolam PK parameters in the presence and absence of brigatinib,<br /><br>including:<br /><br>* Area under the concentration-time curve from time 0 to infinity (AUC*)<br /><br>* Maximum observed concentration (Cmax)<br /><br>* Time of first occurrence of Cmax (tmax).</p><br>