Spots Global Cancer Trial Database for A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib

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Trial Identification

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

Official Title: 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

Study ID: NCT00996762

Conditions

Neoplasms, Breast

Interventions

lapatinib

Study Description

Brief 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.

Detailed Description: