Trials / Completed
CompletedNCT00477282
Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer
A Phase 3 Study of Safety and Efficacy of Karenitecin Versus Topotecan Administered for 5 Consecutive Days Every 3 Weeks in Patients With Advanced Epithelial Ovarian Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 509 (actual)
- Sponsor
- BioNumerik Pharmaceuticals, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Karenitecin | Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days) |
| DRUG | Topotecan | Topotecan 1.5 mg/m2/day administered as a single daily IV infusion over 30 minutes for 5 consecutive days every 3 weeks (21 days) |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2007-05-23
- Last updated
- 2020-03-12
Locations
48 sites across 5 countries: Hungary, Lithuania, Poland, Romania, Russia
Source: ClinicalTrials.gov record NCT00477282. Inclusion in this directory is not an endorsement.