Trials / Completed
CompletedNCT00046111
A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | topotecan | A topoisomerase I inhibitor used for ovarian and lung cancer treatment |
Timeline
- Start date
- 2001-09-01
- Primary completion
- 2004-04-01
- Completion
- 2004-04-01
- First posted
- 2002-09-23
- Last updated
- 2017-05-30
Locations
5 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00046111. Inclusion in this directory is not an endorsement.