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

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

SyB C-1101

"SyB C-1101(rigosertib sodium) will be administered to two cohorts at either 280 mg/day or 560 mg/day.~The dose 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 study will involve treatment through the second cycle, but treatment can be continued for 3 or more cycles if conditions for continued administration are satisfied. However, treatment will be limited to a maximum of 6 cycles including the first cycle."

Trial Locations (4)

Unknown

Research site, Nagoya

Research site, Isehara

Research site, Sendai

Research site, Kyoto

Sponsors
All Listed Sponsors
lead

SymBio Pharmaceuticals

INDUSTRY