NCT00996762

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

An Open-label, Randomized, Adaptive Design, Two-period Crossover Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib Compared to the Commercial Tablet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms, Breast

Interventions

Type	Name	Description
DRUG	lapatinib	1250 mg or 1500 mg lapatinib commercial tablet

Timeline

• Start date: 2009-11-12
• Primary completion: 2012-09-18
• Completion: 2012-09-18
• First posted: 2009-10-16
• Last updated: 2017-11-13

Locations

9 sites across 2 countries: United States, South Korea