A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib

2014-07-23 21:12:26 | BioPortfolio


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 one week on each formulation and PK samples will be collected on Day 7 and 14 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 on Day 15, 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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


ErbB2 Overexpressing




GSK Investigational Site
United States





Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:12:26-0400

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Medical and Biotech [MESH] Definitions

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