This is an extension study study to investigate long term safety of SyB L-1101 when administered intravenously every 4 weeks to the patients who have completed 8 cycles in the study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome. Antitumor effects will also be investigated in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period. The treatment period of 28 days (3 days of administration + 25 days of observation) constitutes 1 cycle. The dose at cycle 8 in the study 2011005 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 9). From cycle 10 on, the dose of SyB L-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
Fukuoka, Fukuoka, Japan
Research Site
Kagoshima, Kagoshima-ken, Japan
Research site
Isesaki, Kanagawa, Japan
Adverse Events
Total number affected by any adverse events (details are presented in adverse event section)
Time frame: Up to 20 weeks
Disease Response Assessment
Disease progression According to the International Working Group 2006 response criteria for Myelodysplastic Syndrome, "disease progression" is defined as no evidence of complete remission (CR), partial remission, marrow CR, stable disease, or failure, and as meeting one of the following conditions. 1. when pretreatment percentage of bone marrow blasts \< 5%: ≥ 50% increase to \> 5%. 2. when pretreatment percentage of bone marrow blasts 5 to 10%: ≥ 50% increase to \> 10%. 3. when pretreatment percentage of bone marrow blasts 10 to 20%: ≥ 50% increase to \> 20%. 4. when pretreatment percentage of bone marrow blasts 20 to 30%: ≥ 50% increase to \> 30%. 5. other: at least one of the following: decrease to ≤ 50% of neutrophil or platelet count at maximum response, ≥ 2 g/dL decrease in Hgb or transfusion dependence (in the absence of other factors, such as infection, gastrointestinal bleeding, or hemolysis).
Time frame: Up to 20 weeks
Serious Adverse Events
Total number affected any serious adverse events
Time frame: Up to 20 weeks
Hematologic Improvement
NCA (not considered assessable) no evidence of hematologic improvement -erythroid, -platelet, -neutrophil, progressive disease, or relapse, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome.
Time frame: Up to 20 weeks
Cytogenetic Response
NCA (not considered assessable) no evidence of cytogenetic response, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome.
Time frame: Up to 20 weeks
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Research Site
Kumamoto, Kumamoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Kurashiki, Okayama-ken, Japan
Research Site
Kawagoe, Saitama, Japan
Research Site
Tokyo, Tokyo, Japan