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

Lung Cancer, Small Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046111
• Other study ID #: 104864-A/565
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2002
• Last updated: May 24, 2017
• Start date: September 2001
• Est. completion date: April 2004

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer, Small Cell
• Small Cell Lung Carcinoma
• Solid Tumor Cancer

Intervention

Drug:
• topotecan
A topoisomerase I inhibitor used for ovarian and lung cancer treatment

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Ottawa	Ontario
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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