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

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• lapatinib — DRUG
  1250 mg or 1500 mg lapatinib commercial tablet

Study Details

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.

Key Dates

Start date

Nov 12, 2009

Status verified

Nov 2017

Primary completion

Sep 18, 2012

Completion

Sep 18, 2012

Study Design

Enrollment

158 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Part 1-3
  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.

Primary Outcome Measure

The primary PK endpoints will be AUC(0-24) and Cmax of lapatinib [ Time Frame: Period 1 Day 7 and Period 2 Day 7 ]

Locations (8)

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