CompletedPhase 1

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

United States107 participantsStarted 2004-10-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Women who are pregnant or lactating * Subjects with uncontrolled emesis, regardless of etiology, active infection.

What they're measuring

Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2.

Timeframe: Days 1, 8

Trial details

NCT IDNCT00259935

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-07-05

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