A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Lapatinib — DRUG
  Treatment A: one dose of 1250mg lapatinib 1 hour before starting a low-fat breakfast; Treatment B: one dose of 1250mg lapatinib 1 hour after finishing a low fat breakfast; or Treatment C: one dose of 1250mg lapatinib 1 hour after finishing a high-fat breakfast.

Study Details

This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of lapatinib administered after a high or low-fat meal.

Key Dates

Start date

Mar 6, 2009

Status verified

Nov 2017

Primary completion

Mar 22, 2011

Completion

Mar 22, 2011

Study Design

Enrollment

24 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• Experimental: Period 1
  Treatment A, B or C
• Experimental: Period 2
  Treatment A, B or C
• Experimental: Period 3
  Treatment A, B or C

Primary Outcome Measure

Protocol specified pharmacokinetic parameters [ Time Frame: 3 weeks ]

Locations (2)

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