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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00087958 |
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Date of registration:
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16/07/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment
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Scientific title:
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Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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168 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00087958 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Belgium
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Canada
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Colombia
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Denmark
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France
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Germany
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Ireland
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Italy
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Korea, Republic of
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Netherlands
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South Africa
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Spain
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Switzerland
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Turkey
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United States
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Contacts
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Name:
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ICD CSD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
In order to be eligible for this trial you must:
- Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has
spread beyond its original location) or a recurrence of the cancer in its original
location that cannot be removed by surgery.
- Have received previous treatment with anthracyclines (e.g. doxorubicin [Adriamycin
or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or
docetaxel [Taxotere]) and capecitabine (e.g. Xeloda) for your breast cancer and your
doctor has determined that these treatments are no longer of benefit to you.
- Be at least 18 years of age
- Not be taking other treatments for your cancer at the time you enter the trial.
- Not be pregnant
- Additionally, there are other criteria for study entry that a doctor participating in
this study will need to review in detail with you and clinical assessments may need
to be performed (lab tests, CT scans).
Exclusion Criteria:
- None listed here. Can be discussed with your doctor.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: XRP9881
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Primary Outcome(s)
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Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors
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Secondary Outcome(s)
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Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks
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Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs.
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Time to tumor response and duration of response.
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Secondary ID(s)
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EUDRACT : 2004-000572-14
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XRP9881B/2001
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EFC6088
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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