Combination Therapy of SyB C-1101 and Azacytidine in Patients With Myelodysplastic Syndrome

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2015

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

SyB C-1101 and Azacytidine

"This study is a multi-center open-label study to assess the tolerability of oral administration of SyB C-1101 twice daily from Day 1 to Day 21 in combination with subcutaneous administration or intravenous drip infusion of azacitidine once daily at a dose of 75 mg/m2 (body surface) for 7 days during the period between Day 8 and Day 16, and to estimate the recommended dose (RD) of C-1101.~SyB C-1101 will be administered at a daily dose of 560 mg or 840 mg in each of the 2 cohorts for a treatment period of 1 cycle for 28 days, including 21 days for SyB C-1101 treatment followed by 7 days of follow-up."

Trial Locations (4)

Unknown

Research Site, Nagoya

Research Site, Kakamigahara

Research Site, Sendai

Research Site, Shinagawa

Sponsors
All Listed Sponsors
lead

SymBio Pharmaceuticals

INDUSTRY