A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib
Status:
Completed
Trial end date:
2012-09-18
Target enrollment:
Participant gender:
Summary
This study will assess alternative formulations of lapatinib for relative bioavailability and
bioequivalence (BE) with the current commercial formulation (reference). Subjects will be
dosed for at least one week (7 days) on each formulation and PK samples will be collected
after each lapatinib formulation dosing Period on Period 1 Day 7 and Period 2 Day7 at
pre-dose and up to 24 hrs post dose. The study may evaluate up to three alternative test
formulations. After subjects complete the PK evaluation at the End of Study Visit, if they
are eligible, they will have the option to enter EGF111767, an open-label, Phase Ib
continuation study of lapatinib monotherapy or lapatinib in combination with other
anti-cancer treatments.