A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
This Study is in two parts, the first part is to make sure that combining a potential new
treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal
cancer is safe. Once this part is complete and it is decided that it is safe to continue the
Study will the go on to look at the efficacy of the two drugs together. This will be done by
studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy
cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real
cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that
non-one can tell the difference between the two treatment groups. This kind of study design
is done to try to avoid the chance that the results might be biased in some way. The overall
aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard
treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results.
That is, it's better than giving standard treatment alone in helping to prevent progression
of mCRC.