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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

NCT00327743 Phase 1/Phase 2 COMPLETED

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.

Details

Lead sponsorSanofi
PhasePhase 1/Phase 2
StatusCOMPLETED
Enrolment34
Start date2006-08
Completion2009-03

Conditions

Interventions

Primary outcomes

Countries

United States, France