- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00062686
GW572016 For Treatment Of Refractory Metastatic Breast Cancer
April 14, 2015 updated by: GlaxoSmithKline
An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens
This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.
Study Overview
Study Type
Interventional
Enrollment
200
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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Buenos Aires, Argentina, C1455BWU
- GSK Investigational Site
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Villejuif Cedex, France, 94805
- GSK Investigational Site
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Bayern
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Augsburg, Bayern, Germany, 86150
- GSK Investigational Site
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Bebington, Wirral, United Kingdom, CH63 4JY
- GSK Investigational Site
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London, United Kingdom, SW3 6JJ
- GSK Investigational Site
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Manchester, United Kingdom, M20 4BX
- GSK Investigational Site
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- GSK Investigational Site
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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:
- Signed Informed Consent.
- Histologically confirmed Stage IIIb or IV breast cancer.
- Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
- Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
- Documented disease progression of the most recent treatment is required.
- Archived tumor tissue available for testing.
- Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
- At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
- Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
- Able to swallow and retain oral medication.
- Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
- Adequate kidney and liver function.
- Adequate bone marrow function.
Exclusion criteria:
- Pregnant or lactating.
- Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
- Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
- History of other malignancy.
- Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
- Active or uncontrolled infection.
- Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
- Known history of or clinical evidence of leptomeningeal carcinomatosis.
- Active infection.
- Concurrent cancer therapy or investigational therapy.
- Use of oral or IV steroids.
- Unresolved or unstable serious toxicity from prior therapy.
- Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.
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)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Tumor response rate
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Secondary Outcome Measures
Outcome Measure |
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clinical benefit rate time to progression 4 and 6 month progression free survival overall survival
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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
November 1, 2003
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
February 1, 2005
Study Registration Dates
First Submitted
June 11, 2003
First Submitted That Met QC Criteria
June 11, 2003
First Posted (Estimate)
June 12, 2003
Study Record Updates
Last Update Posted (Estimate)
April 15, 2015
Last Update Submitted That Met QC Criteria
April 14, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGF20008
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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