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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00046111

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

0.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

1 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

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Apr 1, 2004

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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. [Four weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	New York	New York	United States	10021
2	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19111
3	GSK Investigational Site	Nashville	Tennessee	United States	37203
4	GSK Investigational Site	San Antonio	Texas	United States	78229
5	GSK Investigational Site	Ottawa	Ontario	Canada	K1H 1C4