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

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

SyB L-1101

"SyB L-1101(rigosertib sodium) will be administered to two cohorts at either 1200 mg/day or 1800 mg/day.~The dose will be administered intravenously for 72 continuous hours (3 days), followed by 11-day observation period. The treatment period of 14 days (3 days of administration + 11 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."

Trial Locations (3)

Unknown

Research Site, Nagoya

Research Site, Fukuoka

Research Site, Tokyo

Sponsors
All Listed Sponsors
lead

SymBio Pharmaceuticals

INDUSTRY