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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00821054 |
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.
Condition | Intervention | Phase |
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Advanced or Metastatic ErbB2-Overexpressing Breast Cancer |
Drug: Lapatinib |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | An Open Label Study to Examine the Effects of Low-Fat and High-Fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients |
Estimated Enrollment: | 18 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Period 3: Experimental
Treatment A, B or C
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Drug: Lapatinib
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.
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Period 1: Experimental
Treatment A, B or C
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Drug: Lapatinib
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.
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Period 2: Experimental
Treatment A, B or C
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Drug: Lapatinib
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.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Is male or female. A female is eligible to enter and participate in the study if she is of:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, New York | |
GSK Investigational Site | |
Buffalo, New York, United States, 14263 | |
Canada, Quebec | |
GSK Investigational Site | |
Montreal, Quebec, Canada, H2W 1T8 | |
Netherlands | |
GSK Investigational Site | |
Amsterdam, Netherlands, 1066 CX |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111582 |
Study First Received: | December 18, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00821054 |
Health Authority: | Canada: Health Canada; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United States: Food and Drug Administration |
Phase I Food Effect |
Skin Diseases Breast Neoplasms Lapatinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |