Safety, Efficacy and Pharmacokinetic Between Capecitabine and Exisulind in Metastatic Breast Cancer Patients
Status:
Completed
Trial end date:
2003-02-01
Target enrollment:
Participant gender:
Summary
The primary objective of the phase I study is to determine a safe dose for combination
therapy with capecitabine and exisulind. A secondary objective is to assess pharmacokinetic
interactions between the two drugs and assess the biological activity of exisulind.
The primary objective of the Phase II part of this study is to assess the anti-tumor activity
of this combination therapy measured by objective tumor response. Secondary end points also
assessed will be toxicity of therapy, duration of response and time to progression.