A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Lung Cancer, Small Cell

In brief

The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.

Key facts

Study ID

NCT00259935

Run by

GlaxoSmithKline

People needed

107

Starts

2004-10-04

Expected to finish

2007-07-05

Last updated by the study team

2017-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with advanced solid tumors.
• At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
• Subjects must be free of post-treatment side effects.

You may not qualify if…

• Women who are pregnant or lactating
• Subjects with uncontrolled emesis, regardless of etiology, active infection.

Where it is running

• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — The Bronx, 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
• GSK Investigational Site — Morgantown, West Virginia, United States
• GSK Investigational Site — Amsterdam, Netherlands
• GSK Investigational Site — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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