This is a phase 1, 2-part, pharmacokinetic study in patients with advanced solid tumors or hematologic malignancies and varying degrees of liver dysfunction (normal function, moderate hepatic impairement or severe hepatic impairment) as defined by the National Cancer Institute (NCI) Organ Dysfunction Working Group.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Unnamed facility
Fairway, Kansas, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Houston, Texas, United States
Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib
Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Time frame: Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles])
Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Time frame: Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)
Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs
Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).
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Time frame: Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)