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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00849329 |
This study will characterize the effect of elevated gastric pH mediated by the proton-pump inhibitor, esomeprazole, on the relative bioavailability of lapatinib in subjects with metastatic ErbB2 positive breast cancer.
Condition | Intervention | Phase |
---|---|---|
Advanced or Metastatic ErbB2-Overexpressing Breast Cancer |
Drug: lapatinib Drug: lapatinib plus esomeprazole |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer |
Estimated Enrollment: | 16 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Period 1: Experimental
1250mg lapatinib once daily in the morning
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Drug: lapatinib
1250mg lapatinib
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Period 2: Experimental
1250mg lapatinib once daily in the morning in combination with esomeprazole 40mg once daily at bedtime.
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Drug: lapatinib plus esomeprazole
1250mg lapatinib plus esomeprazole 40mg
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United States, Ohio | |
GSK Investigational Site | |
Cleveland, Ohio, United States, 44106 | |
United States, South Carolina | |
GSK Investigational Site | |
Greenville, South Carolina, United States, 29605 | |
Korea, Republic of | |
GSK Investigational Site | |
songpa-gu, Seoul, Korea, Republic of, 138-736 | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 135-710 | |
Netherlands | |
GSK Investigational Site | |
UTRECHT, Netherlands, 3584 CX | |
Spain | |
GSK Investigational Site | |
Hospitalet de Llobregat (Barcelona), Spain, 08907 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 109275 |
Study First Received: | February 12, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00849329 History of Changes |
Health Authority: | Canada: Biologics and Genetics Therapeutic Directorate (B>D); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); South Korea: Food and Drug Administration; Spain: Agencia Española del Medicamento y Productos Sanitarios; United States: Food and Drug Administration; United States: Institutional Review Board |
lapatinib (GW572016), subject, pharmacokinetic, esomeprazole, proton-pump inhibitor, drug interaction, Phase 1 |
Proton Pump Inhibitors Skin Diseases Omeprazole Breast Neoplasms |
Lapatinib Protein Kinase Inhibitors Breast Diseases |
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Agents Breast Neoplasms Omeprazole Lapatinib Enzyme Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Anti-Ulcer Agents Breast Diseases |