Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study
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|ClinicalTrials.gov Identifier: NCT02002936|
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : December 12, 2016
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: SyB C-1101||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial of SyB C-1101 in Patients With Myelodysplastic Syndrome - Extension Study|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|Experimental: SyB C-1101||
Drug: SyB C-1101
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.
- Adverse Events [ Time Frame: Up to 3 years ]Total number affected by any adverse events (details are presented in adverse event section)
- Total Efficacy in Hematologic Remission (IWG2006 Criteria) [ Time Frame: Up to 3 years ]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.
- Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria. [ Time Frame: Up to 3 years ]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.
- Cytogenetic Response Ratio According to IWG 2006 Criteria [ Time Frame: Up to 3 years ]NCA (not considered assessable): no cytogenetic response
- Overall Survival [ Time Frame: Up to 3 years ]Survived
- Changes in Clinical Laboratory Test Results [ Time Frame: Up to 3 years ]Clinically significant changes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002936
|Nagoya, Aichi, Japan|
|Isehara, Kanagawa, Japan|
|Sendai, Miyagi, Japan|
|Study Director:||Katsuhisa Goto||SymBio Pharmaceuticals|