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

Tracking Information

First Received Date ^ICMJE

September 19, 2002

Last Updated Date

March 6, 2006

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00046111 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

This study has no secondary outcome measures.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Solid Tumors

Intervention ^ICMJE

Drug: topotecan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00046111

Responsible Party

Study ID Numbers ^ICMJE

104864-A/565

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP