A Phase I Study Of Oral Topotecan And Lapatinib In Subjects With Advanced Solid Tumors

This is a single-arm, dose escalation, Phase I study in which doses of oral topotecan will be escalated and lapatinib will be given initially as a fixed dose. This study will examine oral topotecan administered on a five-consecutive day schedule in combination with daily lapatinib. This study will be conducted in two parts. Part 1 of the study will investigate the impact of lapatinib on the bioavailability of oral topotecan (bioavailability phase) and Part 2 of the study will consist of dose finding to determine the MTD regimen of the combination (dose escalation phase).