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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00288249
First received: February 6, 2006
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Breast Cancer, Metastatic
Drug: Sagopilone (BAY86-5302, ZK 219477)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Tumor response rate (complete or partial response according to RECIST) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of complete or partial tumor response [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Time to tumor progression [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: December 2005
Study Completion Date: January 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 2 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.
Experimental: Arm 3 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.
Experimental: Arm 4 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.
Experimental: Arm 1 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic breast cancer
  • No previous treatment with taxanes, and vinca alkaloids
  • Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

  • More than 2 previous chemotherapies
  • Previous participation in another trial within the last 4 weeks
  • Breast feeding
  • Active infections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288249

Locations
Austria
Wien, Austria, 1090
Wien, Austria, 1100
Belgium
Brasschaat, Belgium, 2930
Bulgaria
Plovdiv, Bulgaria, 4001
Sofia, Bulgaria, 01784
Varna, Bulgaria, 9000
France
Angers, France, 49033
Bordeaux, France, 33076
Clermont Ferrand, France, 63011
Saint Herblain Cedex, France, 44805
Vandoeuvre les Nancy, France, 54500
Germany
Berlin, Germany, 10117
Italy
Forlì, FC, Italy, 47100
Milano, MI, Italy, 20162
Reggio Emilia, RE, Italy, 42100
Poland
Olsztyn, Poland, 10-228
Warszawa, Poland, 02-781
Slovenia
Ljubljana, Slovenia, 1000
Spain
Madrid, Spain, 28040
Málaga, Spain, 29010
United Kingdom
Manchester, Greater Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00288249     History of Changes
Other Study ID Numbers: 91464, 2005-003216-30, 309544
Study First Received: February 6, 2006
Last Updated: May 5, 2014
Health Authority: Austria: Federal Ministry for Health and Women
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:
Breast Cancer
Breast Neoplasms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Epothilones
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014