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

NCT00046111 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-05-30

No results posted yet for this 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.

Conditions

  • Lung Cancer, Small Cell
  • Solid Tumor Cancer

Interventions

DRUG

topotecan

A topoisomerase I inhibitor used for ovarian and lung cancer treatment

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2004-04-30
Completion
2004-04-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00046111 on ClinicalTrials.gov