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CompletedPhase 1NCT00259935
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedtopotecan

The study team can explain what participation involves.

Who it may be forLung Cancer, Small Cell

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 14, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?GlaxoSmithKline

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
GlaxoSmithKline
Interventions being studied
Drug: topotecan
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion criteria
  • Women who are pregnant or lactating
  • Subjects with uncontrolled emesis, regardless of etiology, active infection.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • GSK Investigational SiteLebanon, New Hampshire
  • GSK Investigational SiteThe Bronx, New York
  • GSK Investigational SitePhiladelphia, Pennsylvania
  • GSK Investigational SiteNashville, Tennessee
  • GSK Investigational SiteSan Antonio, Texas
  • GSK Investigational SiteMorgantown, West Virginia
  • GSK Investigational SiteAmsterdam
  • GSK Investigational SiteUtrecht

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 14, 2017. Always confirm current availability with the study team.

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