|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Sanofi-Aventis |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00327743 |
Purpose
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 |
|
Breast Cancer Cancer |
Drug: larotaxel (XRP9881) Drug: capecitabine |
Phase I Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| ChemIDplus related topics: | Capecitabine |
| 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 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Public Registry ICD | GV-Contact-us@sanofi-aventis.com |
| United States, New Jersey | |||||
| Sanofi-Aventis | Recruiting | ||||
| Bridgewater, New Jersey, United States, 08807 | |||||
| Contact GV-Contact-us@sanofi-aventis.com | |||||
| France | |||||
| Sanofi-aventis | Recruiting | ||||
| Paris, France | |||||
| Contact GV-Contact-us@sanofi-aventis.com | |||||
| Sanofi-Aventis |
| Study Director: | ICD | Sanofi-Aventis |
More Information
Related Info 
  |
| Responsible Party: | sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | TCD6511, EudraCT:2006-006474-21 |
| First Received: | May 4, 2006 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00327743 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|