Trials / Completed
CompletedNCT00246688
Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer
Randomized, Multicenter, Prospective Two-arm, Open-label Phase II Study to Investigate the Efficacy and Safety of Two ZK219477 i.v. Infusions (3-hour Infusion of 16mg/m2 Versus 0.5-hour Infusion of 16 mg/m2) in Patients With Recurrent Ovarian Cancer Progressing During, or Within 6 Months of the End of Platinum-based Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if this epothilone leads to a response in patients with recurrent ovarian cancer that has progressed during, or in the last six months since a treatment of platinum-based chemotherapy. We also aim to look at the safety of the study drug and assess the impact of the infusion duration on tolerability.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sagopilone (BAY86-5302 , ZK219477) | 10.5 mg lyophilized sagopilone per vial |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2007-06-01
- Completion
- 2007-06-01
- First posted
- 2005-10-31
- Last updated
- 2015-12-31
Source: ClinicalTrials.gov record NCT00246688. Inclusion in this directory is not an endorsement.