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

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

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
Lung Cancer, Small Cell Solid Tumor Cancer	Drug: topotecan	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Topotecan hydrochloride Topotecan

U.S. FDA Resources

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. [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	September 2001
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Primary Group 40 subjects on medium doses of Topotecan and tested for bioequivalence for 4 weeks.	Drug: topotecan A topoisomerase I inhibitor used for ovarian and lung cancer treatment Other Name: topotecan

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 Investigational Site
New York, New York, United States, 10021
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
Canada, Ontario
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 1C4

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00046111 History of Changes
Other Study ID Numbers:	104864-A/565
Study First Received:	September 19, 2002
Last Updated:	May 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

oral
Bioequivalence
Hycamtin
Topotecan

Additional relevant MeSH terms:

Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic

Bronchial Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012