Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Lapatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

2-period crossover, Period 1 (D1-7) will receive either the commercial formulation or the alternative formulation. Period 2 (D1-7) will receive the formulation not received in Period 1. There will be 3 parts with 3 different alternative formulations. Subjects will only participate in one part.

1250 mg or 1500 mg lapatinib commercial tablet

lapatinib

GSK Clinical Trials

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.

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

GlaxoSmithKline

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib	NCT00996762	Neoplasms, Brea...	lapatinib	18 Years -	GlaxoSmithKline
A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib	NCT00996762	Neoplasms, Brea...	lapatinib	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for bioequivalence, lapatinib, gw572016