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

PHASE1CompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

SyB C-1101

"SyB C-1101(rigosertib sodium) will be administered orally twice daily for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days (14 days of administration + 7 days of observation) constitutes 1 cycle.~The dose at cycle 6 in the study 2012002 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 7).~From cycle 8 on, the dose of SyB C-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle."

Trial Locations (4)

Unknown

Research Site, Nagoya

Research Site, Isehara

Research Site, Kyoto

Research Site, Sendai

Sponsors
All Listed Sponsors
lead

SymBio Pharmaceuticals

INDUSTRY