Lymphoma, Malignant Clinical Trial
Official title:
An Open-Label, Phase 1, Two-Way, Crossover Study of the Effect of Food on the Pharmacokinetics of TAK-659 in Patients With Advanced Solid Tumor and/or Lymphoma Malignancies
The purpose of this study is to characterize the effect of food on the single-dose PK of TAK-659 in participants with advanced solid tumors and/or lymphomas.
The drug being tested in this study is called TAK-659. TAK-659 is being tested in participants with advanced solid tumors and/or lymphomas in order to determine the effect of food on the PK of single oral dose of TAK-659 tablet formulation. The study will enroll approximately 20 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as: - TAK-659 100 mg Fasted + TAK-659 100 mg Fed - TAK-659 100 mg Fed + TAK-659 100 mg Fasted All participants will be asked to take single oral dose of TAK-659 tablet on Day 1 and Day 8 of a 15-day food effect treatment period. Upon completion of the food effect treatment period, participants can continue in the optional post food effect treatment period to receive TAK-659 100 mg, once daily in a 28-day treatment cycle until disease progression, unacceptable toxicity, or the start of another anticancer therapy upon request by the investigator and agreement by the project clinician. This single or multi-center trial will be conducted in the United States. The overall time to participate in this study is up to 58 weeks. Participants will visit the clinic on Day -1 and remain confined until Day 15 of food effect treatment period. Participants will make a visit to the clinic after 28 days after last dose of study drug for a follow-up assessment. ;
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