The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
A topoisomerase I inhibitor used for ovarian and lung cancer treatment
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
San Antonio, Texas, United States
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.
Time frame: Four weeks
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GSK Investigational Site
Ottawa, Ontario, Canada