Trials / Completed
CompletedNCT00259935
A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency 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 (4C)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | topotecan | topotecan |
Timeline
- Start date
- 2004-10-04
- Primary completion
- 2007-07-05
- Completion
- 2007-07-05
- First posted
- 2005-12-01
- Last updated
- 2017-11-14
Locations
8 sites across 2 countries: United States, Netherlands
Source: ClinicalTrials.gov record NCT00259935. Inclusion in this directory is not an endorsement.