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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00288249
First Posted: February 7, 2006
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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
Intervention Model: Parallel Assignment
Masking: None (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 6 weeks ]
    The proportion of subjects with either complete or partial response according to the modified RECIST criteria was calculated as best overall response after 6 courses of therapy (i.e., before Course 7).


Secondary Outcome Measures:
  • Duration of complete or partial tumor response [ Time Frame: Every 6 weeks ]
    Defined as the time between the first date that confirmed complete or partial response was established as "overall response" and the first date that recurrence or overall response of progressive disease was documented

  • Time to tumor progression [ Time Frame: Every 6 weeks ]
    Defined as the time from the start of study treatment to the first objective evidence of tumor progression, symptomatic deterioration, or death from cancer


Enrollment: 82
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
Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)
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
Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)
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
Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in 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
Each subject was scheduled to receive one infusion of ZK 219477 every 3 weeks in one of the respective arms (16 mg/m2 in Arm 1, 12 mg/m2 in Arm 2, 22 mg/m2 [30-minute infusion] in Arm 3 and 22 mg/m2 [3-hour infusion] in Arm 4)
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00288249     History of Changes
Other Study ID Numbers: 91464
2005-003216-30 ( EudraCT Number )
309544 ( Other Identifier: Company Internal )
First Submitted: February 6, 2006
First Posted: February 7, 2006
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Bayer:
Breast Cancer
Breast Neoplasms

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