Phase I/II Study of Capecitabine Plus Aflibercept to Treat Metastatic Colorectal Cancer
Status:
Completed
Trial end date:
2016-06-12
Target enrollment:
Participant gender:
Summary
The Primary Phase I objectives are to determine the recommended phase II dose for the
capecitabine and aflibercept doublet combination; and to describe any dose limiting and
non-dose limiting toxicities. The Phase II Primary objective is to determine progression free
survival associated with this regimen. The Phase II secondary objectives are to determine
response rate associated with this regimen; to determine overall survival associated with
this regimen; and to explore any correlation of clinical outcome with baseline and on
treatment changes in blood-based angiogenesis biomarkers.
This open-label, non-randomized phase I/II trial is designed to assess the safety,
tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic
colorectal cancer.