This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Number of Participants With Dose-limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.
Time frame: Cycle 1 (up to 21 or 28 days, depending on treatment arm)
Number of Participants With Any Clinical or Laboratory Adverse Event
This is a measure of the number of participants who experienced any adverse event (AE) while on study.
Time frame: First dose up to 30 days after last dose (up to 2 years)
Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)
AUC\[0-24\] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle. AUC\[0-24\] for the 28-day cycle is reported as Outcome Measures 4 and 5.
Time frame: Cycle 1, Day 1 (Hour 0 through Hour 24)
Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)
AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC\[0-24\] for the Day 3 doses is reported as Outcome Measure 5.
Time frame: Cycle 1, Day 1 (Hour 0 through Hour 24)
Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements. AUC\[0-24\] for the Day 1 doses is reported as Outcome Measure 4.
Time frame: Cycle 1, Day 3 (Hour 0 through Hour 24)