Status:
COMPLETED
A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors
Lead Sponsor:
Takeda
Conditions:
Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
The study will enroll approximately 20 participants to achieve approximately 15 PK-evaluable participants for assessment. This study will consist of 2 parts: Part A of the study will evaluate the effe...
Eligibility Criteria
Inclusion
- 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.
- Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Have at least 1 target lesion per response evaluation criteria in solid tumors (RECIST) version 1.1.
- 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.
- Suitable venous access for study-required blood sampling (that is, including PK and laboratory safety tests).
Exclusion
- Systemic treatment with strong or moderate cytochrome P450 3A (CYP3A) inhibitors or inducers within 14 days before enrollment.
- Prior therapy with brigatinib.
- Received prior ALK-inhibitor therapy within 7 days before the first dose of study drug.
- Treatment with any investigational systemic anticancer agents within 14 days or 5 half-lives, whichever is longer, before the first dose of study drug.
- 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.
- Received antineoplastic monoclonal antibodies within 30 days before the first dose of study drug.
- 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.
- Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.
Key Trial Info
Start Date :
June 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03420742
Start Date
June 26 2019
End Date
April 29 2021
Last Update
January 27 2023
Active Locations (14)
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1
Hopital de la Timone
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
2
Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat
Paris, Île-de-France Region, France, 75018
3
Centro di Riferimento Oncologico di Aviano
Aviano, Pordenone, Italy, 33081
4
Policlinico Sant'Orsola Malpighi
Bologna, Italy, 40138