- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00044525
Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients
December 18, 2014 updated by: Bayer
An Uncontrolled Phase II Study Evaluating the Efficacy and Safety of Intravenous BAY59-8862 in Patients With Taxane-Resistant Metastatic Breast Cancer
Breast cancer is the most common form of cancer among women in developing countries, accounting for approximately one-fifth of all female cancers in the United States.
Although mortality rates are declining in some countries, it remains the leading cause of death in women aged 40-55 years.
The median survival for women with metastatic breast cancer is 2-3 years but there is significant variability in this population.
The primary goals of treatment in patients with metastatic breast cancer are improvement or maintenance of quality of life and prolongation of survival.
The taxanes, paclitaxel and docetaxel, were incorporated into the treatment of metastatic breast cancer in the 1990's.
The usefulness of the taxanes is limited by the development of tumor resistance to these agents.
This phase II trial with BAY59-8862 will be conducted to determine the anti-tumor efficacy of BAY59-8862 in taxane-resistant metastatic breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10117
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Baden-Württemberg
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Stuttgart, Baden-Württemberg, Germany, 70376
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Thüringen
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Jena, Thüringen, Germany, 07740
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Attica
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Maroussi, Attica, Greece, 15123
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Creta
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Heraklion, Creta, Greece, 711 10
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Ashkelon, Israel, 78306
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Haifa, Israel, 31096
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Tel Aviv, Israel, 64239
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Tel Hashomer, Israel, 52621
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Biella, Italy, 13900
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Cuneo, Italy, 12100
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Forlì, Italy, 47100
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Parma, Italy, 43100
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Udine, Italy, 33100
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Bergamo
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Treviglio, Bergamo, Italy, 24047
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Milano
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Rozzano, Milano, Italy, 20089
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Olsztyn, Poland, 10-228
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Warszawa, Poland, 00-909
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Warszawa, Poland, 02-781
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Aargau
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Aarau, Aargau, Switzerland, 5001
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Greater London
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London, Greater London, United Kingdom, NW3 2QG
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London, Greater London, United Kingdom, SW3 6JJ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female patients with a proven diagnosis of metastatic breast cancer
- Measurable disease as defined by the presence of at least one measurable lesion
- Patients must have received at least 3 weeks of continuous therapy with Taxane
- patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
- Patients who failed on hormone therapy
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, liver and kidney function
- Patients with active brain metastases may be included
Exclusion Criteria:
- Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia; surgery within 4 weeks of study entry; serious infections; HIV infection; chronic hepatitis B or C; patients with brain metastases must be without a seizure; hypersensitivity to taxanes; organ transplants; some previous cancers
- Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant
- Others: pregnant or breast-feeding patients; women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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1 h intravenous infusion every 3 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Primary Completion (Actual)
February 1, 2004
Study Completion (Actual)
February 1, 2004
Study Registration Dates
First Submitted
August 30, 2002
First Submitted That Met QC Criteria
September 3, 2002
First Posted (Estimate)
September 4, 2002
Study Record Updates
Last Update Posted (Estimate)
December 23, 2014
Last Update Submitted That Met QC Criteria
December 18, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10654
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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