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CompletedPhase 1NCT00046111
Official study title

A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

Study summary

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.

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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 · Solid Tumor Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 30, 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?5 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
  • Written informed consent
  • Patients with confirmed advanced solid tumors.
  • No prior chemotherapy within 5 years of the diagnosis of SCLC (small cell lung cancer).
  • At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
  • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
Reasons someone may not be able to joinExclusion criteria
  • Women who are pregnant or lactating.
  • Patients of child bearing potential refusing to practice adequate contraception.
  • Patients with uncontrolled vomiting.
  • Active infection.
  • Patients with clinical evidence of any gastrointestinal (GI) conditions which would alter GI absorption or GI motility.
  • Patients requiring treatment with cyclosporin A.
  • Severe medical problems other than the cancer, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
  • Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for cancer treatment.
  • Use of investigational drug within 30 days prior to the first dose of study medication.

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 SiteNew York, New York
  • GSK Investigational SitePhiladelphia, Pennsylvania
  • GSK Investigational SiteNashville, Tennessee
  • GSK Investigational SiteSan Antonio, Texas
  • GSK Investigational SiteOttawa, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 30, 2017. Always confirm current availability with the study team.

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