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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase I Treatment Completed 18 and over Pharmaceutical / Industry 104864/692
NCT00259935

Trial Description

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.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

GlaxoSmithkline

GSK Clinical Trials, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00259935
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.