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Brief Title: Drug-Drug Interaction Study of TAK-788 and Midazolam in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title: A Phase 1, Open-Label, Multicenter, Drug-Drug Interaction Study of TAK-788 and Midazolam, a Sensitive CYP3A Substrate, in Patients With Advanced Non-Small Cell Lung Cancer
Study ID: NCT04051827
Brief Summary: The purpose of this study is to characterize the effect of repeated oral administration of TAK-788 160 milligram (mg) once daily on the single oral and intravenous dose pharmacokinetics (PK) of midazolam.
Detailed Description: The drug being tested in this study is called TAK-788. The study will characterize the effect of repeated oral administration of TAK-788 160 mg on the single oral- and intravenous-dose PK of midazolam, and will assess the safety and tolerability of TAK-788 in participants with advanced NSCLC. The study will enroll approximately 26 participants. The study will be conducted in 2 parts: Part A (Cycle 1: PK Cycle) and Part B (Cycle 2 to Cycle 24: Treatment Cycles). In Part A, participants will receive midazolam as an oral dose and intravenous infusion, along with oral dose of TAK-788 in a single 30-day cycle. After completion of Part A, eligible participants may enter Part B. In Part B, participants will continue to receive oral dose of TAK-788 that they were receiving and tolerating at the end of Part A in a 28-day treatment cycle for up to 23 cycles of treatment, or until progressive disease (PD), intolerable toxicity, or another discontinuation criterion is met. Based on the opinion of investigator, if a participant continue to experience clinical benefit, treatment with TAK-788 may be continued after PD. This multi-center trial will be conducted in Australia, Singapore and the Netherlands. The overall time to participate in this study is 3 years. Participants will make multiple visits to the clinic and will be followed up for 30 days after the last dose of study drug for a follow-up assessment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Peninsula and Southeast Oncology, Frankston, Victoria, Australia
Nucleus Network, Melbourne, Victoria, Australia
Netherlands Cancer Institute, Amsterdam, Noord-holland, Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
The National University Cancer Institute - Singapore, Singapore, , Singapore
Raffles Hospital, Singapore, , Singapore
Name: Study Director
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR