NCT00288249

Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer

Prospective, Multicenter, Randomized, Independent-group, Open-label Phase II Study to Investigate the Efficacy, Safety and Tolerability of 4 Regimen With 3 Doses of ZK 219477 (16 and 12 mg/m2 Body Surface Area as 3-hour Infusion or 22 mg/m2 Body Surface Area as 30-minute or 3-hour Infusion) in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with metastatic breast cancer

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

• Breast Neoplasms
• Breast Cancer, Metastatic

Interventions

Type	Name	Description
DRUG	Sagopilone (BAY86-5302, ZK 219477)	16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
DRUG	Sagopilone (BAY86-5302, ZK 219477)	12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
DRUG	Sagopilone (BAY86-5302, ZK 219477)	22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
DRUG	Sagopilone (BAY86-5302, ZK 219477)	22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-03-01
• Completion: 2009-01-01
• First posted: 2006-02-07
• Last updated: 2014-12-02

Locations

21 sites across 10 countries: Austria, Belgium, Bulgaria, France, Germany, Italy, Poland, Slovenia, Spain, United Kingdom