Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer
NCT ID: NCT00288249
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2005-12-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Sagopilone (BAY86-5302, ZK 219477)
12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
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)
Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
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)
Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
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)
Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Interventions
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Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Sagopilone (BAY86-5302, ZK 219477)
12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Eligibility Criteria
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Inclusion Criteria
* No previous treatment with taxanes, and vinca alkaloids
* Use of highly effective birth control methods in females of child-bearing potential
Exclusion Criteria
* Previous participation in another trial within the last 4 weeks
* Breast feeding
* Active infections
18 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Vienna, Vienna, Austria
Vienna, Vienna, Austria
Brasschaat, , Belgium
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Vandœuvre-lès-Nancy, France, France
Angers, , France
Bordeaux, , France
Clermont-Ferrand, , France
Saint-Herblain, , France
Berlin, State of Berlin, Germany
Forlì, FC, Italy
Milan, MI, Italy
Reggio Emilia, RE, Italy
Olsztyn, , Poland
Warsaw, , Poland
Ljubljana, , Slovenia
Madrid, Madrid, Spain
Málaga, Málaga, Spain
Manchester, Greater Manchester, United Kingdom
Countries
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Other Identifiers
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2005-003216-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
309544
Identifier Type: OTHER
Identifier Source: secondary_id
91464
Identifier Type: -
Identifier Source: org_study_id