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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00327743 |
The goal of this phase I-II clinical research study is to find the highest safe dose of XRP9881 and capecitabine that can be given in combination in the treatment of metastatic breast cancer in patients who have been previously treated by taxanes and anthracyclines. The safety and effectiveness of this combination will also be studied. Patients participating in the study will be asked to give additional blood samples to look at the level of study drugs in the blood.
Condition | Intervention | Phase |
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Breast Cancer Cancer |
Drug: larotaxel (XRP9881) Drug: capecitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Dose-Escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy |
Estimated Enrollment: | 30 |
Study Start Date: | August 2006 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France |
Study Director: | ICD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | TCD6511, EudraCT:2006-006474-21 |
Study First Received: | May 4, 2006 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00327743 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cancer Alternative Therapies Metastatic Breast Cancer |
Antimetabolites Capecitabine Skin Diseases |
Breast Neoplasms Taxane Breast Diseases |
Antimetabolites Capecitabine Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Skin Diseases Antineoplastic Agents Therapeutic Uses Breast Neoplasms Pharmacologic Actions Breast Diseases |