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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
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.
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Adverse Events
Total number affected by any adverse events (details are presented in adverse event section)
Time frame: Up to 3 years
Total Efficacy in Hematologic Remission (IWG2006 Criteria)
SD (stable disease): according to International Working Group 2006 response criteria for myelodysplastic syndrome, SD was defined as a failure to achieve "complete remission" or "partial remission," but no evidence of progression for \> 8 weeks.
Time frame: Up to 3 years
Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.
NCA (not considered assessable): no evidence of HI-E (hematologic improvement-erythroid), HI-P (hematologic improvement-platelet), HI-N (hematologic improvement-neutorophil), progressive disease, or relapse.
Time frame: Up to 3 years
Cytogenetic Response Ratio According to IWG 2006 Criteria
NCA (not considered assessable): no cytogenetic response
Time frame: Up to 3 years
Overall Survival
Survived
Time frame: Up to 3 years
Changes in Clinical Laboratory Test Results
Clinically significant changes
Time frame: Up to 3 years
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