Conditions: Myelodysplastic Syndrome
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
This is an extension study to investigate long term safety and efficacy of SyB C-1101 when orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who have completed 6 cycles in the study 2012002 whose purpose is to investigate tolerability of SyB C-1101 when administered orally in patients with recurrent/relapsed or refractory myelodysplastic syndrome.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: SyB C-1101
Intervention descriptions: intervention 1: 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.

Protocol document: