Clinical Trials Directory

Trials / Completed

CompletedNCT00359190

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
28 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.

Conditions

Interventions

TypeNameDescription
DRUGlapatinibGW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route

Timeline

Start date
2004-06-29
Primary completion
2008-01-09
Completion
2008-01-09
First posted
2006-08-01
Last updated
2017-11-13

Locations

10 sites across 2 countries: United States, Israel

Source: ClinicalTrials.gov record NCT00359190. Inclusion in this directory is not an endorsement.

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer (NCT00359190) · Clinical Trials Directory