Trials / Completed
CompletedNCT00313248
Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer
Phase 2 Study to Investigate the Efficacy and Safety of ZK-Epothilone (ZK-Epo; ZK 219477) in Patients With Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) in patients with metastatic breast cancer helps to decrease or stop tumor growth.
Detailed description
This study has previously been registered by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sagopilone (ZK 219477) | All patients will receive ZK-Epo at a dose of 16mg/m2 as an intravenous infusion. Chemotherapy for recurrent breast cancer. |
| DRUG | Sagopilone (ZK 219477) | Patients will receive 22mg/m2 as intravenous infusion. |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2008-10-01
- Completion
- 2008-11-01
- First posted
- 2006-04-12
- Last updated
- 2015-12-10
Locations
25 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00313248. Inclusion in this directory is not an endorsement.