Trial Outcomes & Findings for Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study (NCT NCT02002936)

NCT ID: NCT02002936

Last Updated: 2017-02-23

Results Overview

Total number affected by any adverse events (details are presented in adverse event section)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 1 participants
• Primary outcome timeframe: Up to 3 years
• Results posted on: 2017-02-23

Participant Flow

Participant milestones

Measure	SyB C-1101 SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study

Baseline characteristics by cohort

Measure	SyB C-1101 n=1 Participants SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.
Age, Customized 50-59 years	1 participants n=5 Participants
Age, Customized 60-69 years	0 participants n=5 Participants
Age, Customized 70-79 years	0 participants n=5 Participants
Age, Customized 80-years	0 participants n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Total number affected by any adverse events (details are presented in adverse event section)

Outcome measures

Measure

SyB C-1101 n=1 Participants SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.

Adverse Events

1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

SyB C-1101 n=1 Participants SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.

Total Efficacy in Hematologic Remission (IWG2006 Criteria)

1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

SyB C-1101 n=1 Participants SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.

Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.

1 participants

SECONDARY outcome

Timeframe: Up to 3 years

NCA (not considered assessable): no cytogenetic response

Outcome measures

Measure

SyB C-1101 n=1 Participants SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.

Cytogenetic Response Ratio According to IWG 2006 Criteria

1 participants

SECONDARY outcome

Timeframe: Up to 3 years

Survived

Outcome measures

Measure

SyB C-1101 n=1 Participants SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.

Overall Survival

1 participants

SECONDARY outcome

Timeframe: Up to 3 years

Clinically significant changes

Outcome measures

Measure

SyB C-1101 n=1 Participants SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.

Changes in Clinical Laboratory Test Results

0 participants

Adverse Events

SyB C-1101

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SyB C-1101 n=1 participants at risk SyB C-1101 （rigosertib sodium）: Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	100.0% 1/1 • Number of events 1
Eye disorders Asthenopia	100.0% 1/1 • Number of events 1
Musculoskeletal and connective tissue disorders Ligament sprain	100.0% 1/1 • Number of events 1
Gastrointestinal disorders Abdominal pain upper	100.0% 1/1 • Number of events 1
General disorders Pyrexia	100.0% 1/1 • Number of events 1
Gastrointestinal disorders Constipation	100.0% 1/1 • Number of events 1
Injury, poisoning and procedural complications Periodontitis	100.0% 1/1 • Number of events 1

Additional Information

Katsuhisa Goto

SymBio Pharmaceuticals

Phone: +81-3-5472-1127

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place