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
Sponsor study identifier
Secondary identifiers
interventional
82
10 countries
21
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
January 2009
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
February 6, 2006
Actual (reported)February 7, 2006
Actual (reported)March 2008
Actual (reported)January 2009
Actual (reported)Tumor response rate (complete or partial response according to RECIST)
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).
Every 6 weeks
Duration of complete or partial tumor response
Every 6 weeks
Time to tumor progression
Every 6 weeks
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)
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)
16 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
12 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Vienna, State of Vienna, 1090, Austria
Vienna, State of Vienna, 1100, Austria
Brasschaat, 2930, Belgium
Plovdiv, 4001, Bulgaria
Sofia, 01784, Bulgaria
Varna, 9000, Bulgaria
Vandœuvre-lès-Nancy, France, 54500, France
Bayer Study Director
Bayer
82 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy and Safety Study of ZK219477 in Patients With Recurrent Ovarian Cancer
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)
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)
22 mg/m2, 30-minute i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
22 mg/m2, 3-hour i.v. infusion, 1 cycle every 3 weeks. Planned number of cycles : 2-6.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Angers, 49033, France
Bordeaux, 33076, France
Clermont-Ferrand, 63011, France
Saint-Herblain, 44805, France
Berlin, State of Berlin, 10117, Germany
Forlì, FC, 47100, Italy
Milan, MI, 20162, Italy
Reggio Emilia, RE, 42100, Italy
Olsztyn, 10-228, Poland
Warsaw, 02-781, Poland
Ljubljana, 1000, Slovenia
Madrid, Madrid, 28040, Spain
Málaga, Málaga, 29010, Spain
Manchester, Greater Manchester, M20 4BX, United Kingdom
Primary Completion
March 2008
Actual (reported)Study Completion
January 2009
Actual (reported)Last Updated
December 2, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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