A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors.
Four weeks
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
United States: Food and Drug Administration
104864-A/565
NCT00046111
September 2001
April 2004
Name | Location |
---|---|
GSK Investigational Site | Fort Worth, Texas 76104 |
GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
GSK Investigational Site | Germantown, Tennessee 38138 |
GSK Investigational Site | New York, New York 10021 |