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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00259935

Collaborator

(none)

107

Enrollment

Locations

Arm

Actual Duration (Months)

13.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer, Small Cell	Drug: topotecan	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (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 (4C)

Actual Study Start Date :

Oct 4, 2004

Actual Primary Completion Date :

Jul 5, 2007

Actual Study Completion Date :

Jul 5, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All treated subjects Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1.	Drug: topotecan topotecan

Arm

Intervention/Treatment

Experimental: All treated subjects

Subjects were randomized to receive 4 mg of a new formulation and current formulation of oral topotecan on Days 1 and 8 of Course 1.

Drug: topotecan

topotecan

Outcome Measures

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. [Days 1, 8]

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 [Up to 38 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Lebanon	New Hampshire	United States	03756
2	GSK Investigational Site	Bronx	New York	United States	10461
3	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19111
4	GSK Investigational Site	Nashville	Tennessee	United States	37203
5	GSK Investigational Site	San Antonio	Texas	United States	78229
6	GSK Investigational Site	Morgantown	West Virginia	United States	26506
7	GSK Investigational Site	Amsterdam		Netherlands	1066 CX
8	GSK Investigational Site	Utrecht		Netherlands	3584 CX

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00259935

Other Study ID Numbers:

104864/692

First Posted:

Dec 1, 2005

Last Update Posted:

Nov 14, 2017

Last Verified:

Nov 1, 2017

Keywords provided by GlaxoSmithKline

Any Solid Tumor

Additional relevant MeSH terms:

Small Cell Lung Carcinoma

Topotecan

Study Results

No Results Posted as of Nov 14, 2017