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

• Status: Completed
• Trial end date: 2007-07-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Topotecan

Criteria

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.