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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
TAK-659 tablet.
Yale Cancer Center
New Haven, Connecticut, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Montefiore Medical Center
The Bronx, New York, United States
Cmax: Maximum Observed Plasma Concentration for TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-659
Time frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-659
Time frame: Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-659
Time frame: Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-659
Time frame: Day 8 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants With Grade 3 or Above Adverse Event (AE)
AE Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.
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Time frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants With Drug-related AEs
Time frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants With Drug-related Grade 3 or Above AEs
AE Grades will be evaluated as per NCI CTCAE, version 4.03. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.
Time frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants who Experience at Least 1 Serious Adverse Event (SAE)
Time frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants who Discontinue due to an AE
Time frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)
Percentage of Participants who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: Baseline up to 28 days after the last dose of study drug (up to 58 weeks)