Colorectal Neoplasms Clinical Trial
Official title:
An Uncontrolled, Open-label, Phase II Study in Subjects With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First Line Chemotherapy With mFOLFOX6 (Oxaliplatin/ Folinic Acid/5-fluorouracil [5-FU]) in Combination With Regorafenib
This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when
given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with
metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. 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 (the most meaningful result to be tracked) of this study is based on
the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy
of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response
rate observed for the standard therapy only.
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