Trial Outcomes & Findings for Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma (NCT NCT01179490)
NCT ID: NCT01179490
Last Updated: 2013-03-18
Results Overview
The proportion of subjects evaluated as CR was calculated. CR (modified SWOG) requires all of the followings: 1. Decline in serum myeloma protein by ≥75% to ≤25 g/L 2. Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h 3. No increase in skeletal destruction 4. Serum calcium within normal range 5. No blood transfusion required in the previous 3 months
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 36 weeks
Results posted on
2013-03-18
Participant Flow
Participant milestones
| Measure |
SyB L-0501 + Prednisolone
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Age Continuous
|
69.0 Year
STANDARD_DEVIATION 2.3 • n=39 Participants
|
|
Age, Customized
20-29 years
|
0 Participants
n=39 Participants
|
|
Age, Customized
30-39 years
|
0 Participants
n=39 Participants
|
|
Age, Customized
40-49 years
|
0 Participants
n=39 Participants
|
|
Age, Customized
50-59 years
|
0 Participants
n=39 Participants
|
|
Age, Customized
60-69 years
|
3 Participants
n=39 Participants
|
|
Age, Customized
70-84 years
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=39 Participants
|
|
Condition with symptoms of Multiple Myeloma
No
|
5 Participants
n=39 Participants
|
|
Condition with symptoms of Multiple Myeloma
Yes
|
0 Participants
n=39 Participants
|
|
Previous treatment of multiple myeloma
No
|
5 Participants
n=39 Participants
|
|
Previous treatment of multiple myeloma
Yes
|
0 Participants
n=39 Participants
|
|
Reason for not eligible for hematopoietic stem cell transplantation
Age 66 years or older
|
5 Participants
n=39 Participants
|
|
Reason for not eligible for hematopoietic stem cell transplantation
Presence of cardiopulmonary dysfunction
|
0 Participants
n=39 Participants
|
|
Reason for not eligible for hematopoietic stem cell transplantation
Renal dysfunction
|
0 Participants
n=39 Participants
|
|
Reason for not eligible for hematopoietic stem cell transplantation
Other
|
0 Participants
n=39 Participants
|
|
Performance status (P.S.)
0
|
3 Participants
n=39 Participants
|
|
Performance status (P.S.)
1
|
0 Participants
n=39 Participants
|
|
Performance status (P.S.)
2
|
2 Participants
n=39 Participants
|
|
Performance status (P.S.)
3
|
0 Participants
n=39 Participants
|
|
Clinical stage [International staging system (ISS) category]
Stage I
|
0 Participants
n=39 Participants
|
|
Clinical stage [International staging system (ISS) category]
Stage II
|
3 Participants
n=39 Participants
|
|
Clinical stage [International staging system (ISS) category]
Stage III
|
2 Participants
n=39 Participants
|
|
Previous history of multiple myeloma
No
|
5 Participants
n=39 Participants
|
|
Previous history of multiple myeloma
Yes
|
0 Participants
n=39 Participants
|
|
Associated symptom of the primary disease
No
|
0 Participants
n=39 Participants
|
|
Associated symptom of the primary disease
Yes
|
5 Participants
n=39 Participants
|
|
Complications of multiple myeloma
No
|
0 Participants
n=39 Participants
|
|
Complications of multiple myeloma
Yes
|
5 Participants
n=39 Participants
|
|
Serum β2M in clinical stage
|
5.00 mg/L
STANDARD_DEVIATION 1.48 • n=39 Participants
|
|
Height
|
151.40 cm
STANDARD_DEVIATION 8.53 • n=39 Participants
|
|
Weight
|
52.40 kg
STANDARD_DEVIATION 10.41 • n=39 Participants
|
|
Body surface area
|
1.470 m2
STANDARD_DEVIATION 0.185 • n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 36 weeksThe proportion of subjects evaluated as CR was calculated. CR (modified SWOG) requires all of the followings: 1. Decline in serum myeloma protein by ≥75% to ≤25 g/L 2. Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h 3. No increase in skeletal destruction 4. Serum calcium within normal range 5. No blood transfusion required in the previous 3 months
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
|
40.0 Percentage of Participants
Interval 5.3 to 85.3
|
SECONDARY outcome
Timeframe: Up to 36 weeksThe proportion of subjects evaluated as CR \[strict CR (sCR) + CR\] was calculated. sCR (IMWG): CR as defined below plus Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence CR (IMWG): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]
|
0.0 Percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: Up to 36 weeksThe proportion of subjects evaluated as response \[sCR + CR + very good partial response (VGPR) + Partial Response (PR)\] was calculated. VGPR (IMWG): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 h PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to \<200mg per 24 h
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Response Rate (Based on the IMWG Criteria)
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
SECONDARY outcome
Timeframe: Up to 36 weeksThe proportion of subjects evaluated as CR was calculated. CR (Bladé) requires all of the followings: 1. Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR. 2. \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR. 3. No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response) 4. Disappearance of soft tissue plasmacytomas
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
CR Rate Based on the (Bladé) Criteria
|
0.0 Percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: Up to 36 weeksThe proportion of subjects evaluated as response (CR + PR) was calculated. PR (Bladé) requires 1. or all of the others: 1. Some, but not all, of the criteria for CR are fulfilled 2. ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks. 3. Reduction in 24 h urinary light chain excretion either by ≥90% or to \<200 mg, maintained for a minimum of 6 weeks. 4. For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks. 5. ≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination). 6. No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Response Rate (Based on the Bladé Criteria)
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
SECONDARY outcome
Timeframe: Up to 36 weeksThe proportion of subjects evaluated as response (CR + PR) was calculated. PR (SWOG) requires the followings: 1. Decline in myeloma protein of ≥25%-\<74% in serum myeloma protein 2. Reduction in 24h urinary myeloma protein of ≥25%-\<89% 3. No increase in skeletal destruction 4. Serum calcium within normal range
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Response Rate (Based on the Modified SWOG Criteria)
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPFS is the period from patient registration to either the date of recurrence, exacerbation, progression or death. Recurrence, exacerbation, progression were assessed from serum M-protein, urine M-protein, serum free light chain (FLC), the percentage of marrow plasma cells, disappearance of clonal plasma cells, plasma cell tumor in soft tissue, and bone lesion.
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Progression-Free Survival (PFS)
|
205.0 Days
Interval 38.0 to 274.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsTTF is the period from patient registration to either the date of recurrence, exacerbation, progression, death or discontinuation of treatment.
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
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|---|---|
|
Time to Treatment Failure (TTF)
|
205.0 Days
Interval 38.0 to 274.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsDOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Duration of Response (DOR)
|
162.0 Days
Interval 99.0 to 252.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsOS is the period from the date of patient registration to the date of death.
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Overall Survival (OS)
|
205.0 Days
Interval 38.0 to 330.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsAdverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
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|---|---|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
Subjects with adverse event
|
5 Participants
|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
Subjects with related adverse event
|
5 Participants
|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
Subjects with serious adverse event
|
2 Participants
|
|
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
Subjects with related serious adverse event
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsAdverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
Adverse events
|
166 Events
|
|
Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
Related adverse events
|
155 Events
|
|
Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
Serious adverse events
|
4 Events
|
|
Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
Related serious adverse events
|
4 Events
|
SECONDARY outcome
Timeframe: Up to 2 yearsAbnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Subjects with Grade 3 abnormality
|
5 Participants
|
|
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Subjects with Grade 4 abnormality
|
5 Participants
|
|
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Subjects with Grade 5 abnormality
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsAbnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Number of Abnormalities (Grade ≥3) in Laboratory Test Values
Grade 3 abnormalities
|
33 Events
|
|
Number of Abnormalities (Grade ≥3) in Laboratory Test Values
Grade 4 abnormalities
|
39 Events
|
|
Number of Abnormalities (Grade ≥3) in Laboratory Test Values
Grade 5 abnormalities
|
0 Events
|
SECONDARY outcome
Timeframe: On Day 1 onlyPlasma pharmacokinetics (Cmax) of unchanged bendamustine
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Pharmacokinetic Parameters (Cmax)
|
8795.769 ng/mL
Standard Deviation 3907.460
|
SECONDARY outcome
Timeframe: On Day 1 onlyPlasma pharmacokinetics (tmax) of unchanged bendamustine
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Pharmacokinetic Parameters (Tmax)
|
1.00 h
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: On Day 1 onlyPlasma pharmacokinetics (AUC) of unchanged bendamustine
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Pharmacokinetic Parameters (AUC)
|
12315.992 ng・h/mL
Standard Deviation 7900.579
|
SECONDARY outcome
Timeframe: On Day 1 onlyPlasma pharmacokinetics (t1/2) of unchanged bendamustine
Outcome measures
| Measure |
SyB L-0501 + Prednisolone
n=5 Participants
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Pharmacokinetic Parameters (t1/2)
|
0.44 h
Standard Deviation 0.152
|
Adverse Events
SyB L-0501 + Prednisolone
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SyB L-0501 + Prednisolone
n=5 participants at risk
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Septic shock
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Pneumonia bacterial
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
|
Infections and infestations
Acute respiratory distress syndrome
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
SyB L-0501 + Prednisolone
n=5 participants at risk
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
1/5 • Up to 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Up to 2 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Up to 2 years
|
|
Gastrointestinal disorders
Proctalgia
|
20.0%
1/5 • Up to 2 years
|
|
Gastrointestinal disorders
Stomatitis
|
40.0%
2/5 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Up to 2 years
|
|
General disorders
Malaise
|
20.0%
1/5 • Up to 2 years
|
|
General disorders
Oedema
|
20.0%
1/5 • Up to 2 years
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Up to 2 years
|
|
General disorders
Pyrexia
|
20.0%
1/5 • Up to 2 years
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
20.0%
1/5 • Up to 2 years
|
|
Infections and infestations
Infection
|
20.0%
1/5 • Up to 2 years
|
|
Infections and infestations
Pharyngitis
|
20.0%
1/5 • Up to 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
2/5 • Up to 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Blood albumin decreased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Blood creatinine increased
|
40.0%
2/5 • Up to 2 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
40.0%
2/5 • Up to 2 years
|
|
Investigations
Blood potassium increased
|
40.0%
2/5 • Up to 2 years
|
|
Investigations
Blood sodium decreased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Blood urea increased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Blood uric acid decreased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Blood uric acid increased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
C-reactive protein increased
|
60.0%
3/5 • Up to 2 years
|
|
Investigations
CD4 lymphocytes decreased
|
60.0%
3/5 • Up to 2 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Haemoglobin decreased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
100.0%
5/5 • Up to 2 years
|
|
Investigations
Neutrophil count decreased
|
100.0%
5/5 • Up to 2 years
|
|
Investigations
Neutrophil count increased
|
60.0%
3/5 • Up to 2 years
|
|
Investigations
Platelet count decreased
|
100.0%
5/5 • Up to 2 years
|
|
Investigations
Protein total decreased
|
20.0%
1/5 • Up to 2 years
|
|
Investigations
Weight increased
|
40.0%
2/5 • Up to 2 years
|
|
Investigations
White blood cell count decreased
|
100.0%
5/5 • Up to 2 years
|
|
Investigations
White blood cell count increased
|
40.0%
2/5 • Up to 2 years
|
|
Investigations
Blood alkaline phosphatase increased
|
40.0%
2/5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
20.0%
1/5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
20.0%
1/5 • Up to 2 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
60.0%
3/5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
20.0%
1/5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
1/5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
60.0%
3/5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Scab
|
20.0%
1/5 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
20.0%
1/5 • Up to 2 years
|
|
Vascular disorders
Circulatory collapse
|
20.0%
1/5 • Up to 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place