Colorectal Neoplasms Clinical Trial
Official title:
An Open-label Phase IIIb Study of Regorafenib in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy
This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study
to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have
failed after standard therapy and for whom no therapy alternatives exist, in the time between
positive results and approval / availability on the market, and to collect safety data for
regorafenib until market access.
Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase
inhibitor targets certain key proteins that are essential for the survival of the cancer
cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The
growth of the tumor may be decreased by preventing these specific proteins from functioning.
The primary endpoint of this study will be safety.
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