A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors - Full Text View

Purpose

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.

Condition	Intervention	Phase
Solid Tumors	Drug: topotecan	Phase I

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics 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:

To determine the bioequivalence of new formulation (test) of oral topotecan relative to the current Phase III formulation (reference) of oral topotecan by comparing AUC in patients with advanced solid tumors.

Secondary Outcome Measures:

This study has no secondary outcome measures.

Estimated Enrollment:	50
Study Start Date:	February 2002

Eligibility

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

Criteria

Inclusion 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.

Exclusion 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046111

Locations


United States, New York
	GSK Clinical Trials Call Center
	New York, New York, United States, 10021

United States, Pennsylvania
	GSK Clinical Trials Call Center
	Philadelphia, Pennsylvania, United States, 19111

United States, Tennessee
	GSK Clinical Trials Call Center
	Nashville, Tennessee, United States, 37203-1632

United States, Texas
	GSK Clinical Trials Call Center
	San Antonio, Texas, United States, 78229

Canada, Ontario
	GSK Clinical Trials Call Center
	Ottawa, Ontario, Canada, K1H 1C4

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trial, MD	GlaxoSmithKline

More Information

Study ID Numbers:	104864-A/565
First Received:	September 19, 2002
Last Updated:	March 6, 2006
ClinicalTrials.gov Identifier:	NCT00046111
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Bioequivalence

Topotecan

Hycamtin

oral

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 August 21, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00046111