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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00259935

Purpose

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.

Condition	Intervention	Phase
Tumor	Drug: topotecan	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1

Estimated Enrollment:	106
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259935

Locations

United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10461
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, West Virginia
GSK Investigational Site
Morgantown, West Virginia, United States, 26506
Netherlands
GSK Investigational Site
UTRECHT, Netherlands, 3584 CX
GSK Investigational Site
AMSTERDAM, Netherlands, 1066 CX

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104864/692
Study First Received:	November 30, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00259935
Health Authority:	United States: Food and Drug Administration; Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by GlaxoSmithKline:

Any Solid Tumor

Study placed in the following topic categories:

Topotecan

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009