Advanced Breast Cancer (Parts 1 and 2) Clinical Trial
Official title:
A Phase 1/2, Open-Label Study Of Bosutinib Administered In Combination With Capecitabine In Subjects With Solid Tumor And ErbB2 Negative Locally Advanced Or Metastatic Breast Cancer
This is a research study in 2 parts assessing the following parameters of the combination of
the study drug called bosutinib, and a drug called capecitabine: the safety, how well the
subject's body handles the study drug, and preliminary anti-tumor activity as treatment for
different types of cancers in part 1, and breast cancer only in part 2.
In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels
of each drug in order to determine the highest tolerated dose of the combination study
treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest
tolerated dose to see how well the study treatment works to treat breast cancer. In
addition, genetic research testing (research analyses involving genes and gene products)
will be performed on biological samples from subjects.
The study was prematurely discontinued following Part 1 evaluation, when the sponsor concluded that further translational biomarker analyses were needed to better define the breast tumor biomarkers that predict sensitivity to Src family kinase inhibitors. Thus the Sponsor made a determination to stop the study after Part 1 as communicated to investigators on 02Dec2010 . No subjects were enrolled into Part 2 of this study. The study was not terminated due to safety reasons. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment