Trial Outcomes & Findings for SMAC Mimetic LCL161 Alone or With Cyclophosphamide in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01955434)
NCT ID: NCT01955434
Last Updated: 2019-09-10
Results Overview
The primary endpoint of this study is the confirmed overall response rate with single agent LCL161 (prior to initiation of cyclophosphamide). A confirmed overall response is defined as sCR (CR as defined+Normal FLC ratio+Absence of clonal PCs by immunohistochemistry), CR (Negative immunofixation of serum and urine+Disappearance of any soft tissue plasmacytoma+\<5% PCs in Bone Marrow+a normal FLC ratio), VGPR (Serum and urine M-component detectable by immunofixation but not on electrophoresis), or PR (If present at baseline, ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to \<200 mg/24hrs) noted as the objective status on two consecutive evaluations while receiving single agent LCL161.The rate (percentage) of successes will be estimated by the number of successes divided by the total number of evaluable patients times 100. 95% confidence intervals for the true success percentage will be calculated by the exact binomial method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2019-09-10
Participant Flow
Participant milestones
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
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25
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SMAC Mimetic LCL161 Alone or With Cyclophosphamide in Treating Patients With Relapsed or Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
n=25 Participants
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Age, Continuous
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68.0 years
n=5 Participants
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Sex: Female, Male
Female
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9 Participants
n=5 Participants
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Sex: Female, Male
Male
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16 Participants
n=5 Participants
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Region of Enrollment
United States
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25 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 1 yearThe primary endpoint of this study is the confirmed overall response rate with single agent LCL161 (prior to initiation of cyclophosphamide). A confirmed overall response is defined as sCR (CR as defined+Normal FLC ratio+Absence of clonal PCs by immunohistochemistry), CR (Negative immunofixation of serum and urine+Disappearance of any soft tissue plasmacytoma+\<5% PCs in Bone Marrow+a normal FLC ratio), VGPR (Serum and urine M-component detectable by immunofixation but not on electrophoresis), or PR (If present at baseline, ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to \<200 mg/24hrs) noted as the objective status on two consecutive evaluations while receiving single agent LCL161.The rate (percentage) of successes will be estimated by the number of successes divided by the total number of evaluable patients times 100. 95% confidence intervals for the true success percentage will be calculated by the exact binomial method.
Outcome measures
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
n=25 Participants
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Confirmed Overall Response Rate (Stringent Complete Response [sCR], Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) With Single Agent SMAC Mimetic LCL161
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0 percentage of patients
Interval 0.0 to 13.7
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SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.
The overall response rate (percentage) with the addition of cyclophosphamide will be estimated by the number of patients who achieve a confirmed overall response at any time (with SMAC mimetic LCL161 plus cyclophosphamide) divided by the number of evaluable patients times 100. 95% confidence intervals for the true confirmed overall response rate will be calculated by the exact binomial method.
Outcome measures
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
n=23 Participants
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Combination Agent Response Rate
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17.4 percentage of patients
Interval 5.0 to 38.8
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SECONDARY outcome
Timeframe: From registration to disease progression while receiving SMAC mimetic LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 1 yearPopulation: Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.
The event-free survival time is defined as the time from registration to disease progression while receiving LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma. Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of cyclophosphamide. If a patient goes off study treatment and never received cyclophosphamide, they will be censored on the date they went off study treatment. If a patient initiates cyclophosphamide but later discontinues cyclophosphamide due to toxicity and continues LCL161 alone, disease progression on LCL161 alone will be considered an event in this case. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
n=23 Participants
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Event-free Survival
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10.0 months
Interval 4.6 to 24.4
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SECONDARY outcome
Timeframe: Up to 30 days after the last day of study drug treatmentThe maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event are reported below.
Outcome measures
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
n=25 Participants
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Anemia
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24 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Fatigue
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16 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Nausea
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Platelet count decreased
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12.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Neutrophil count decreased
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36.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Lymphocyte count decreased
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52.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Vomiting
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
White blood cell decreased
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20.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Diarrhea
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Rash maculo-papular
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Hyperglycemia
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12.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Lymphocyte count increased
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8 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Syncope
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12.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Hyperuricemia
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Hypotension
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Lung infection
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Pain in extremity
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Sepsis
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4.0 percentage of patients
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Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)
Uriticaria
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4.0 percentage of patients
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SECONDARY outcome
Timeframe: From registration to death due to any cause, assessed up to 1 yearSurvival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
n=25 Participants
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Survival
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NA months
The median overall survival was not reached, and the lower and upper limits of the 95% confidence interval were not available.
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OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearContinuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 1 yearScale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Changes from baseline at each cycle will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's adjustment) using Cohen's cut-offs. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 1 yearContinuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 1 yearContinuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 1 yearContinuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
Serious events: 11 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
n=25 participants at risk
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Immune system disorders
Cytokine release syndrome
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8.0%
2/25 • Number of events 2 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
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Infections and infestations
Lung infection
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4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
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Infections and infestations
Sepsis
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4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
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Investigations
Lymphocyte count decreased
|
16.0%
4/25 • Number of events 5 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
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|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
1/25 • Number of events 3 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Nervous system disorders
Syncope
|
8.0%
2/25 • Number of events 2 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
Other adverse events
| Measure |
Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)
n=25 participants at risk
Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
96.0%
24/25 • Number of events 133 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Gastrointestinal disorders
Abdominal pain
|
24.0%
6/25 • Number of events 16 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Gastrointestinal disorders
Constipation
|
44.0%
11/25 • Number of events 45 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Gastrointestinal disorders
Diarrhea
|
44.0%
11/25 • Number of events 46 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 2 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Gastrointestinal disorders
Nausea
|
76.0%
19/25 • Number of events 71 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Gastrointestinal disorders
Vomiting
|
56.0%
14/25 • Number of events 45 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
General disorders
Edema limbs
|
28.0%
7/25 • Number of events 11 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
General disorders
Fatigue
|
96.0%
24/25 • Number of events 134 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
General disorders
Fever
|
32.0%
8/25 • Number of events 14 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
General disorders
Malaise
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Immune system disorders
Cytokine release syndrome
|
8.0%
2/25 • Number of events 2 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Investigations
Blood bilirubin increased
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Investigations
Lymphocyte count decreased
|
56.0%
14/25 • Number of events 70 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Investigations
Lymphocyte count increased
|
12.0%
3/25 • Number of events 3 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Investigations
Neutrophil count decreased
|
68.0%
17/25 • Number of events 38 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Investigations
Platelet count decreased
|
72.0%
18/25 • Number of events 77 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Investigations
White blood cell decreased
|
48.0%
12/25 • Number of events 43 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
10/25 • Number of events 18 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.0%
3/25 • Number of events 5 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.0%
4/25 • Number of events 37 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
68.0%
17/25 • Number of events 106 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Nervous system disorders
Presyncope
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Psychiatric disorders
Personality change
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.0%
11/25 • Number of events 33 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
44.0%
11/25 • Number of events 26 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.0%
1/25 • Number of events 1 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
48.0%
12/25 • Number of events 22 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
36.0%
9/25 • Number of events 14 • From baseline up to 30 days after last dose of study treatment
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place