MedTrace Logo

Trial Outcomes & Findings for A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma (NCT NCT00920556)

NCT ID: NCT00920556

Last Updated: 2019-02-27

Results Overview

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Approximately up to 12 cycles of 3 weeks each

Results posted on

2019-02-27

Participant Flow

A total of 24 participants with Multiple Myeloma were enrolled in the study. The study was conducted at four centers in United Kingdom and 1 center in Denmark, and was terminated early.

Participant milestones

Participant milestones
Measure
Overall Study
Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited PD, then received bortezomib (1.3 milligram(mg)/meter square (m\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
Overall Study
STARTED
24
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
24

Reasons for withdrawal

Reasons for withdrawal
Measure
Overall Study
Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited PD, then received bortezomib (1.3 milligram(mg)/meter square (m\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
Overall Study
Adverse Event
16
Overall Study
Physician Decision
7
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall Study
n=24 Participants
Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited progressive disease (PD), then received bortezomib (1.3 milligram(mg)/meter square (m\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
Age, Continuous
66.4 Years
STANDARD_DEVIATION 7.83 • n=99 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
Sex: Female, Male
Male
12 Participants
n=99 Participants
Race/Ethnicity, Customized
Race · Afro-Caribbean
3 Participants
n=99 Participants
Race/Ethnicity, Customized
Race · Caucasian
21 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Approximately up to 12 cycles of 3 weeks each

Population: Safety Population was defined as all the participants who received any amount of SRT501 or bortezomib.

An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=24 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
24 Participants
9 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
12 Participants
3 Participants

PRIMARY outcome

Timeframe: Approximately up to 12 cycles of 3 weeks

Population: Modified Intent to Treat (mITT), had participants who completed first (2) cycles of SRT501 monotherapy. Participants dropped were not counted; those withdrew after 2nd cycle were considered evaluable regardless of discontinuation reason; alongwith participants discontinued for missing clinical trial material after 2 cycle, were considered.

Overall response rate, defines proportion of participants with Complete response (CR), Partial response (PR) or Minimal response (MR) as best response for all cycles. In atleast 2 determinations for minimum of 6 week (Wks) for every criteria listed. CR defined as disappearance of original monoclonal (MC) paraprotein (PP) in blood and urine on immunofixation determinations (IFD); \< 5 % plasma cells in bone marrow; no increase in size or number of lytic bone lesions (LBLs); disappearance of soft tissue plasmacytomas (STP). PR defined as \>= 50% reduction (RE) in level of serum MC PP for 2 IFDs; if present RE in 24 hour urinary light chain excretion (ULCE) by \>= 90% RE or \<200 mg; \>= 50% RE in STP for; no increase in size or number of LBLs. MR criteria defined were \>= 25% to \<=49% RE serum MC PP; if present 50 to 89% RE in 24 hour LCE exceeding 200 mg/24 hour; 25% to 49% RE in size of STP; no increase in size or number of LBLs.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Overall Response Rate
0 Participants
3 Participants

PRIMARY outcome

Timeframe: Up to 12 cycles of 3 weeks each

Population: mITT Population.

PR includes some, but not all, criteria for CR providing the remaining criteria are satisfied: ≥50% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, reduction in 24 hr urinary light chain excretion by either ≥90% or to \<200 mg for at least 2 determinations for a minimum of 6 weeks, ≥50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Partial Response (PR) as Best Response (BR)
0 Participants
2 Participants

PRIMARY outcome

Timeframe: Up to 12 cycles of 3 weeks each

Population: mITT Population.

MR includes some, but not all, criteria for PR providing the remaining criteria satisfied: ≥25% to ≤ 49% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, a 50 to 89% reduction in 24 hr light chain excretion, which still exceeds 200 mg/24 hr, for at least 2 determinations for a minimum of 6 weeks, 25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Minor Response (MR) as Best Response (BR)
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Up to 12 cycles of 3 weeks each

Population: mITT

PR includes some, but not all, criteria for CR providing the remaining criteria are satisfied: ≥50% reduction in the level of serum monoclonal paraprotein for at least 2 immunofixation determinations for a minimum of 6 weeks, If present, reduction in 24 hr urinary light chain excretion by either ≥90% or to \<200 mg for at least 2 determinations for a minimum of 6 weeks, ≥50% reduction in the size of soft tissue plasmacytomas (by clinical or radiographic examination) for a minimum of 6 weeks, No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Partial Response (PR) as Last Observed Response (LOR)
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Up to 12 cycles of 3 weeks each

Population: mITT Population

Stable disease included not meeting the criteria for MR or PD.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Stable Disease (SD) as Best Response (BR)
3 Participants
4 Participants

PRIMARY outcome

Timeframe: Up to 12 cycles of 3 weeks each

Population: mITT Population.

Stable disease included not meeting the criteria for MR or PD.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Stable Disease (SD) as Last Observed Response (LOR)
2 Participants
4 Participants

PRIMARY outcome

Timeframe: Up to 12 cycles of 3 weeks each

Population: mITT Population.

PD includes one or more of the following criteria: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, \>25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Progressive Disease (PD) PD as Best Response (BR)
1 Participants
2 Participants

PRIMARY outcome

Timeframe: Up to 12 cycles of 3 weeks each

Population: mITT Population.

PD includes one or more of the following criteria: \>25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation, \>25% increase in 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/24 hr and confirmed on a repeat investigation, \>25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%., Definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas, Development of new bone lesions or soft tissue plasmacytomas (not including compression fracture), Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Number of Participants With Progressive Disease (PD) PD as Last Observed Response (LOR)
2 Participants
4 Participants

PRIMARY outcome

Timeframe: From Day 1 till disease progression (approximately 12 cycles of 3 weeks each)

Population: mITT Population. Only those participants available at the specified timepoints were analyzed.

Time to disease progression was defined as the time from first dose until objective tumor progression. Participants who did not experience tumor progression were censored at their last known date in the study. It was estimated using Kaplan-Meier methodology. Participants who did not experience tumor progression were censored at their last known date in the study. The first quartile for time to disease progression was evaluated when 25th percentile of participants of mITT population reported disease progression. Similarly, median and 75th percentile of participants of MITT population was planned to be reported. If, less than 75th percentile of participants reported disease progression at the end of the study period, then the observation was censored for the purpose of this analysis and in such case the data was planned to be reported as not evaluable (NA).

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=4 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Time to Disease Progression
2.8 Months
Interval 2.0 to 2.8
2.8 Months
Interval 1.3 to
NA indicates 'Q3 is not evaluable' as less than 75th percentile of participants reported disease progression.

PRIMARY outcome

Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)

Population: Safety Population. Only those participants available at the specified timepoints were analyzed.

Blood samples collected to evaluate the hematology parameters were WBC count, neutrophils, lymphocytes and platelets. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=24 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets
WBC count
0.55 10^9 cells per liter (L)
Standard Deviation 2.76
0.07 10^9 cells per liter (L)
Standard Deviation 1.48
Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets
Neutrophils
0.27 10^9 cells per liter (L)
Standard Deviation 1.32
0.32 10^9 cells per liter (L)
Standard Deviation 1.46
Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets
Lymphocytes
0.09 10^9 cells per liter (L)
Standard Deviation 1.30
-0.34 10^9 cells per liter (L)
Standard Deviation 0.30
Change From Baseline in Hematology: White Blood Cell (WBC) Count, Neutrophils, Lymphocytes, Platelets
Platelets
-12.1 10^9 cells per liter (L)
Standard Deviation 58.1
-9.3 10^9 cells per liter (L)
Standard Deviation 66.3

PRIMARY outcome

Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)

Population: Safety population. Only those participants available at the specified time-points were analyzed.

Blood samples were collected to evaluate the hematology parameter hematocrit. Change from Baseline was defined as the value of baseline minus from the End of study visit. Baseline was defined as Day 1.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=21 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Change From Baseline in Hematology: Hematocrit
-0.04 Proportion of red blood cells in blood
Standard Deviation 0.05
-0.03 Proportion of red blood cells in blood
Standard Deviation 0.04

PRIMARY outcome

Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)

Population: Safety population. Only those participants available at the specified timepoints were analyzed.

Blood samples were collected to evaluate the hematology parameter hemoglobin. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=21 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Change From Baseline in Hematology: Hemoglobin
-11.4 Gram per litre
Standard Deviation 15.0
-9.17 Gram per litre
Standard Deviation 14.3

PRIMARY outcome

Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)

Population: Safety population. Only those participants available at the specified time points were analyzed.

Blood samples were collected to evaluate the hematology parameter RBC. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=21 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Change From Baseline in Hematology: Red Blood Cell (RBC)
-0.30 10^12 cells per liter
Standard Deviation 0.51
-0.16 10^12 cells per liter
Standard Deviation 0.43

PRIMARY outcome

Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected to evaluate hematology parameters serum creatinine and total bilirubin. Change from Baseline was defined as the value of baseline minus from the End of study visit. Baseline was defined as Day 1.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=24 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Change From in Baseline Biochemistry: Serum Creatinine, Total Bilirubin
Serum creatinine
59.8 Micromole per liter
Standard Deviation 123.5
3.60 Micromole per liter
Standard Deviation 8.41
Change From in Baseline Biochemistry: Serum Creatinine, Total Bilirubin
Total bilirubin
1.6 Micromole per liter
Standard Deviation 5.65
0.80 Micromole per liter
Standard Deviation 2.44

PRIMARY outcome

Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)

Population: Safety population. Only those participants available at the specified time points were analyzed.

Blood samples were collected to evaluate the biochemistry parameter urea and bicarbonate. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=24 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=9 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Change From Baseline in Biochemistry -Urea, Bicarbonate
Bicarbonate
-0.81 millimole per liter
Standard Deviation 3.41
0.64 millimole per liter
Standard Deviation 1.10
Change From Baseline in Biochemistry -Urea, Bicarbonate
Urea
3.50 millimole per liter
Standard Deviation 7.87
-0.18 millimole per liter
Standard Deviation 1.61

PRIMARY outcome

Timeframe: Baseline (Day 1) and End of Study assessments/follow-up approximately 28 days (+/- 7 days) following the last dose of SRT501 or SRT501 and bortezomib (approximately 280 days)

Population: Safety Population. Only those participants available at the particular timepoints were analyzed

Blood samples were collected to evaluate the biochemistry parameter PT/INR. Change from Baseline was defined as the value of Baseline minus from the End of study visit. Baseline was defined as Day 1.

Outcome measures

Outcome measures
Measure
SRT501 Monotherapy
n=13 Participants
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. SRT501 was not administered on Day 21 of each cycle.
SRT501 + Bortezomib
n=6 Participants
The eligible participants in this arm received an intravenous solution of Bortezomib at 1.3 mg/m\^2 in conjunction with SRT501 (5.0 g/day) daily dosing. Bortezomib was administered prior to breakfast and SRT501 administration, on Day 1, 4, 8 and 11 in every 21 day cycle. It was given as per the local institution's guidelines and standards of care. SRT501 + Bortezomib, is a subset of arm SRT501 monotherapy.
Change From Baseline in Biochemistry: Prothrombin Time (PT)/ International Normalized Ratio (INR)
0.11 Ratio of PT/INR
Standard Deviation 0.41
0.05 Ratio of PT/INR
Standard Deviation 0.16

SECONDARY outcome

Timeframe: Cycle 1 Day 1, Cycle 1 Day 2 and Cycle 1 Day 20 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose. Day 2 and Day 20, samples collected post-dose. Each cycle duration was 21 days.

Population: Subjects who receive study drug and have adequate pharmacokinetic data available will be included in the pharmacokinetics population, with data summarized by dose group. Data not collected due to early termination of the study.

Pharmacokinetic sampling on Day1/2 and Day 20/21 of Cycle 1 for participants ready to participate was planned. The sampling was planned to be collected at timepoints on Cycle 1 Day 1 at pre-dose, 30 minute, 1 hour, 2 hour, 4 hour, 6 hour and 24 hour post-dose and the same timepoints on Day 2 and Day 20 post- dose. It was to be collected in participants who fasted atleast for an hour. Due to early termination of the study, the data for Pharmacokinetic analysis was not collected.

Outcome measures

Outcome data not reported

Adverse Events

SRT501

Serious events: 12 serious events
Other events: 24 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
SRT501
n=24 participants at risk
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.
Blood and lymphatic system disorders
Anemia
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Cardiac disorders
Sinus Bradycardia
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Nausea
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Vomiting
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
General disorders
Disease progression
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
General disorders
Pyrexia
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
Pneumonia
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
Neutropenic sepsis
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
Urinary tract infection
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
Viral infection
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Metabolism and nutrition disorders
Dehydration
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Renal and urinary disorders
Renal failure acute
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Renal and urinary disorders
Renal failure
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Renal and urinary disorders
Renal impairment
4.2%
1/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.

Other adverse events

Other adverse events
Measure
SRT501
n=24 participants at risk
The eligible participants in this arm received 5 g of SRT501, oral suspension every morning at the same time approximately 15-30 minutes following consumption of breakfast) on all dosing days, for 20 consecutive days in a 21-day cycle for a maximum period of 12 cycles. There was no time between the cycles i.e Day 1 of a cycle was started on the day following Day 21 of the previous cycle. No administration of SRT501, will occur on Day 21 of each cycle.
Respiratory, thoracic and mediastinal disorders
COUGH
25.0%
6/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
20.8%
5/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Nausea
79.2%
19/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Diarrhoea
75.0%
18/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Vomiting
50.0%
12/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Constipation
29.2%
7/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Dyspepsia
20.8%
5/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
General disorders
Fatigue
45.8%
11/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
General disorders
PYREXIA
16.7%
4/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
General disorders
OEDEMA PERIPHERAL
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
General disorders
CHILLS
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
General disorders
DISEASE PROGRESSION
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Nervous system disorders
HEADACHE
37.5%
9/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Nervous system disorders
NEUROPATHY PERIPHERAL
25.0%
6/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Nervous system disorders
DIZZINESS
20.8%
5/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Nervous system disorders
DYSGEUSIA
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Nervous system disorders
LETHARGY
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
37.5%
9/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
25.0%
6/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
BACK PAIN
25.0%
6/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
16.7%
4/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
BONE PAIN
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
JOINT SWELLING
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Musculoskeletal and connective tissue disorders
NECK PAIN
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Metabolism and nutrition disorders
ANOREXIA
29.2%
7/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Metabolism and nutrition disorders
HYPOKALAEMIA
16.7%
4/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Metabolism and nutrition disorders
DECREASED APPETITE
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
NASOPHARYNGITIS
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
ORAL CANDIDIASIS
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
PNEUMONIA
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
RHINITIS
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Infections and infestations
URINARY TRACT INFECTION
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Blood and lymphatic system disorders
ANAEMIA
33.3%
8/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Blood and lymphatic system disorders
NEUTROPENIA
25.0%
6/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Blood and lymphatic system disorders
THROMBOCYTOPENIA
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Psychiatric disorders
DEPRESSION
16.7%
4/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Psychiatric disorders
CONFUSIONAL STATE
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Psychiatric disorders
ANXIETY
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Skin and subcutaneous tissue disorders
RASH
33.3%
8/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Skin and subcutaneous tissue disorders
PRURITUS
16.7%
4/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Investigations
WEIGHT DECREASED
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Investigations
BLOOD CREATININE INCREASED
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Renal and urinary disorders
RENAL FAILURE ACUTE
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Renal and urinary disorders
RENAL IMPAIRMENT
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Vascular disorders
HYPERTENSION
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Cardiac disorders
TACHYCARDIA
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Abdominal distension
16.7%
4/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Oral pain
12.5%
3/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Abdominal pain
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Abdominal pain upper
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Ascites
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Eructation
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.
Gastrointestinal disorders
Hypoaesthesia oral
8.3%
2/24 • From Day 1 to Follow up (Approximately up to 12 cycles of 3 weeks each)
SAE and Non-serious data was reported for safety population. At the time the participant was judged to have progressive disease (PD) (after receiving at least 4 cycles of SRT501 monotherapy), the participant also received bortezomib (1.3 mg/m2 on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) in conjunction with daily SRT501 dosing (N=9). Data presented for SRT501, which combines AE details for SRT501 as well as SRT501 and Bortezomib.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER