At a glance
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Phase I Clinical Trial of SyB C-1101 in Patients With Myelodysplastic Syndrome - Extension Study
In Brief
A Phase 1 clinical trial evaluating SyB C-1101 for Myelodysplastic Syndrome. Completed, enrolled 1 participant across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.