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

NCT01700335 - Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) | Biotech Hunter | Biotech Hunter