1
Participants
Start Date
December 31, 2014
Primary Completion Date
May 31, 2015
Study Completion Date
May 31, 2015
SyB L-1101
SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period. The treatment period of 28 days (3 days of administration + 25 days of observation) constitutes 1 cycle. The dose at cycle 8 in the study 2011005 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 9). From cycle 10 on, the dose of SyB L-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle.
Research Site, Nagoya
Research Site, Fukuoka
Research Site, Kagoshima
Research site, Isesaki
Research Site, Kumamoto
Research Site, Sendai
Research Site, Kurashiki
Research Site, Kawagoe
Research Site, Tokyo
Lead Sponsor
SymBio Pharmaceuticals
INDUSTRY