An Ascending and Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of HKI-272 Administered Orally to Japanese Subjects With Advanced Solid Tumors
This is a phase 1 open-label sequential-group study of ascending single and multiple oral
doses administered to subjects with advanced solid tumors. Each subject will participate in
only 1 dose group and will receive a single dose of test article, followed by a 1-week
observation period, and then will receive the test article administered once-daily by mouth
in cycles consisting of 28 days. Subjects will be enrolled in groups of 3 to 6. Adverse
events and dose-limiting toxicities will be assessed from the first single dose.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety will be assessed through adverse event evaluation, physical exams, and laboratory evaluations. Efficacy will be assessed through radiographic evaluation.
Japan: Pharmaceuticals and Medical Devices Agency