A Phase I Study Of Oral Topotecan And Lapatinib In Subjects With Advanced Solid Tumors
Status:
Withdrawn
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
This is an open-label, Phase I study of oral topotecan administered in combination with
lapatinib in subjects with advanced solid tumors. This Phase I study will evaluate the
safety, tolerability, and pharmacokinetics of oral topotecan administered in combination with
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 maximum-tolerated dose
(MTD) regimen of the combination (dose escalation phase). In Part 2 of the study, the dose of
oral topotecan will be escalated while lapatinib will be given initially as fixed doses. The
primary objective of the study is to determine the MTD regimen of oral topotecan administered
for five-consecutive days every 21 days in combination with daily lapatinib in subjects with
advanced solid tumors.