Long Term Safety Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study

PHASE1CompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

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.

Trial Locations (9)

Unknown

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

Sponsors
All Listed Sponsors
lead

SymBio Pharmaceuticals

INDUSTRY