Trial Outcomes & Findings for Long Term Safety Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study (NCT NCT02000154)

NCT ID: NCT02000154

Last Updated: 2017-03-31

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 20 weeks
• Results posted on: 2017-03-31

Participant Flow

Participant milestones

Measure	SyB L-1101 SyB L-1101 （rigosertib sodium for intravenous formulation）: A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose).
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 L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study

Baseline characteristics by cohort

Measure	SyB L-1101 n=1 Participants SyB L-1101 （rigosertib sodium for intravenous formulation）: A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose).
Age, Customized 60-69 years	0 participants n=5 Participants
Age, Customized 70-79 years	1 participants n=5 Participants
Age, Customized 80- years	0 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 20 weeks

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

Outcome measures

Measure

SyB L-1101 n=1 Participants SyB L-1101 （rigosertib sodium for intravenous formulation）: A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose).

Adverse Events

1 participants

SECONDARY outcome

Timeframe: Up to 20 weeks

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).

Outcome measures

Measure

SyB L-1101 n=1 Participants SyB L-1101 （rigosertib sodium for intravenous formulation）: A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose).

Disease Response Assessment

1 participants

SECONDARY outcome

Timeframe: Up to 20 weeks

Total number affected any serious adverse events

Outcome measures

Measure

SyB L-1101 n=1 Participants SyB L-1101 （rigosertib sodium for intravenous formulation）: A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose).

Serious Adverse Events

0 participants

SECONDARY outcome

Timeframe: Up to 20 weeks

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.

Outcome measures

Measure

SyB L-1101 n=1 Participants SyB L-1101 （rigosertib sodium for intravenous formulation）: A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose).

Hematologic Improvement

1 participants

SECONDARY outcome

Timeframe: Up to 20 weeks

NCA (not considered assessable)

no evidence of cytogenetic response, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome.

Outcome measures

Measure

SyB L-1101 n=1 Participants SyB L-1101 （rigosertib sodium for intravenous formulation）: A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose).

Cytogenetic Response

1 participants

Adverse Events

SyB L-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 L-1101 n=1 participants at risk SyB L-1101 （rigosertib sodium for intravenous formulation）: A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose).
Skin and subcutaneous tissue disorders Pruritus	100.0% 1/1 • Number of events 1
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • Number of events 1
Blood and lymphatic system disorders Splenomegaly	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