Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (LN) (NCT NCT02176486)
NCT ID: NCT02176486
Last Updated: 2019-04-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Baseline up to Day 101 (30 days after last dose of study drug)
Results posted on
2019-04-08
Participant Flow
Participants took part in the study at 8 investigative sites in the United States, Spain and Russia from 09 June 2014 to 19 January 2018.
Participants with a historical diagnosis of lupus nephritis (LN) were enrolled to receive ixazomib as multiple rising doses (MRD) of 0.5 milligram (mg) in Cohort A and 2.0 mg in Cohort B. This study was terminated early after the completion of Cohorts A and B due to lack of sufficient enrollment to complete the study.
Participant milestones
| Measure |
Pooled Placebo
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (LN)
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
Russia
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Height
|
169.3 centimeter (cm)
STANDARD_DEVIATION 0.58 • n=93 Participants
|
167.0 centimeter (cm)
STANDARD_DEVIATION 3.39 • n=4 Participants
|
171.5 centimeter (cm)
STANDARD_DEVIATION 6.56 • n=27 Participants
|
169.1 centimeter (cm)
STANDARD_DEVIATION 4.48 • n=483 Participants
|
|
Weight
|
88.67 kilogram (kg)
STANDARD_DEVIATION 4.216 • n=93 Participants
|
87.56 kilogram (kg)
STANDARD_DEVIATION 16.891 • n=4 Participants
|
92.43 kilogram (kg)
STANDARD_DEVIATION 7.192 • n=27 Participants
|
89.46 kilogram (kg)
STANDARD_DEVIATION 11.229 • n=483 Participants
|
|
Body Mass Index (BMI)
|
30.92 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.441 • n=93 Participants
|
31.40 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.971 • n=4 Participants
|
31.64 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.660 • n=27 Participants
|
31.36 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.399 • n=483 Participants
|
|
Smoking Classification
Never smoked
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Smoking Classification
Current smoker
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Smoking Classification
Ex-smoker
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Alcohol Classification
Never drank
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Alcohol Classification
Current drinker
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Consumption of Alcohol
Drank less than or equal to (<=) 4 drinks per day
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Consumption of Alcohol
Not reported
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Female Reproductive Status
Surgically sterile
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Female Reproductive Status
Female of childbearing potential
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Female Reproductive Status
Not applicable (participant were male)
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Pharmacogenomics (PGx) Consent Obtained
PGx was obtained
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Pharmacogenomics (PGx) Consent Obtained
PGx was not obtained
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 101 (30 days after last dose of study drug)Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Grade Greater Than or Equal to (>=) 2 Treatment Emergent Adverse Event (TEAE)
|
33.3 percentage of participants
|
20.0 percentage of participants
|
25.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 101 (30 days after last dose of study drug)Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One Treatment Emergent Serious Adverse Event (SAE)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 168Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced at Least One AE Leading to Study Drug Discontinuation
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 168Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Markedly Abnormal Value (MAV) for Hematologic Parameters
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Day 84
Baseline
|
1.7567 milligram per milligram creatinine
Standard Deviation 1.66796
|
2.6134 milligram per milligram creatinine
Standard Deviation 2.11100
|
0.7535 milligram per milligram creatinine
Standard Deviation 0.40827
|
|
Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Day 84
Change at Day 84
|
-0.1680 milligram per milligram creatinine
Standard Deviation 1.03388
|
-0.4740 milligram per milligram creatinine
Standard Deviation 0.96565
|
0.9943 milligram per milligram creatinine
Standard Deviation 0.73183
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Change From Baseline in Serum Creatinine (sCR) Level at Day 84
Baseline
|
91.347 micromoles per liter (mcmol/L)
Standard Deviation 18.4019
|
72.488 micromoles per liter (mcmol/L)
Standard Deviation 54.2779
|
81.770 micromoles per liter (mcmol/L)
Standard Deviation 31.7708
|
|
Change From Baseline in Serum Creatinine (sCR) Level at Day 84
Change at Day 84
|
-2.947 micromoles per liter (mcmol/L)
Standard Deviation 22.2468
|
1.768 micromoles per liter (mcmol/L)
Standard Deviation 7.3961
|
13.260 micromoles per liter (mcmol/L)
Standard Deviation 39.2029
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Day 84
Baseline
|
88.7 milliliter/minute/1.73 square meter
Standard Deviation 28.11
|
130.0 milliliter/minute/1.73 square meter
Standard Deviation 62.02
|
103.5 milliliter/minute/1.73 square meter
Standard Deviation 38.77
|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Day 84
Change at Day 84
|
6.3 milliliter/minute/1.73 square meter
Standard Deviation 22.19
|
2.6 milliliter/minute/1.73 square meter
Standard Deviation 29.26
|
-0.5 milliliter/minute/1.73 square meter
Standard Deviation 19.60
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: The pharmacodynamics (PD) set consisted of all participants who received study drug and had at least 1 post dose PD measurement. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Change From Baseline in Levels of Autoantibodies (Anti-double-stranded Deoxyribonucleic Acid [dsDNA]) at Day 84
Change at Day 84
|
-4.3 international units/milliliter (IU/mL)
Standard Deviation 6.03
|
7.5 international units/milliliter (IU/mL)
Standard Deviation 9.40
|
9.5 international units/milliliter (IU/mL)
Standard Deviation 75.76
|
|
Change From Baseline in Levels of Autoantibodies (Anti-double-stranded Deoxyribonucleic Acid [dsDNA]) at Day 84
Baseline
|
18.7 international units/milliliter (IU/mL)
Standard Deviation 12.70
|
34.3 international units/milliliter (IU/mL)
Standard Deviation 32.57
|
129.3 international units/milliliter (IU/mL)
Standard Deviation 140.66
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: The PD set consisted of all participants who received study drug and had at least 1 post dose PD measurement. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Outcome measures
| Measure |
Pooled Placebo
n=3 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 Participants
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Change From Baseline in Complement Protein C3 and C4 at Day 84
Complement Protein C3: Baseline
|
122.3 milligram per deciliter (mg/dL)
Standard Deviation 59.47
|
82.2 milligram per deciliter (mg/dL)
Standard Deviation 23.67
|
110.3 milligram per deciliter (mg/dL)
Standard Deviation 40.24
|
|
Change From Baseline in Complement Protein C3 and C4 at Day 84
Complement Protein C3: Change at Day 84
|
-20.3 milligram per deciliter (mg/dL)
Standard Deviation 26.76
|
-7.4 milligram per deciliter (mg/dL)
Standard Deviation 10.50
|
-19.5 milligram per deciliter (mg/dL)
Standard Deviation 13.18
|
|
Change From Baseline in Complement Protein C3 and C4 at Day 84
Complement Protein C4: Baseline
|
29.0 milligram per deciliter (mg/dL)
Standard Deviation 13.08
|
12.4 milligram per deciliter (mg/dL)
Standard Deviation 8.26
|
20.0 milligram per deciliter (mg/dL)
Standard Deviation 9.56
|
|
Change From Baseline in Complement Protein C3 and C4 at Day 84
Complement Protein C4: Change at Day 84
|
-4.7 milligram per deciliter (mg/dL)
Standard Deviation 4.73
|
-0.8 milligram per deciliter (mg/dL)
Standard Deviation 1.92
|
-6.0 milligram per deciliter (mg/dL)
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (Cycle length is equal to [=] 28 days)Population: The pharmacokinetic (PK) set consisted of all participants who received one dose of ixazomib and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Pooled Placebo
n=5 Participants
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=3 Participants
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
168 hours
|
0.0000 nanogram per milliliter (ng/mL)
Standard Deviation 0.00000
|
0.0000 nanogram per milliliter (ng/mL)
Standard Deviation 0.00000
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
Pre-dose
|
0.0000 nanogram per milliliter (ng/mL)
Standard Deviation 0.00000
|
0.0000 nanogram per milliliter (ng/mL)
Standard Deviation 0.00000
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
0.25 hour
|
0.0000 nanogram per milliliter (ng/mL)
Standard Deviation 0.00000
|
0.0000 nanogram per milliliter (ng/mL)
Standard Deviation 0.00000
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
0.5 hour
|
0.4244 nanogram per milliliter (ng/mL)
Standard Deviation 0.69887
|
2.5033 nanogram per milliliter (ng/mL)
Standard Deviation 4.33590
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
1 hour
|
0.6776 nanogram per milliliter (ng/mL)
Standard Deviation 0.68219
|
2.2000 nanogram per milliliter (ng/mL)
Standard Deviation 2.35841
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
1.5 hours
|
0.5056 nanogram per milliliter (ng/mL)
Standard Deviation 0.72535
|
2.3400 nanogram per milliliter (ng/mL)
Standard Deviation 2.38627
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
2 hours
|
0.5134 nanogram per milliliter (ng/mL)
Standard Deviation 0.52152
|
2.2767 nanogram per milliliter (ng/mL)
Standard Deviation 2.07447
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
4 hours
|
0.1082 nanogram per milliliter (ng/mL)
Standard Deviation 0.24194
|
1.1700 nanogram per milliliter (ng/mL)
Standard Deviation 1.01602
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
8 hours
|
0.0000 nanogram per milliliter (ng/mL)
Standard Deviation 0.00000
|
0.9967 nanogram per milliliter (ng/mL)
Standard Deviation 0.86327
|
—
|
|
Plasma Concentrations of Ixazomib at Each Scheduled Collection Time
24 hours
|
0.0000 nanogram per milliliter (ng/mL)
Standard Deviation 0.00000
|
0.5493 nanogram per milliliter (ng/mL)
Standard Deviation 0.48634
|
—
|
Adverse Events
Pooled Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A: Ixazomib 0.5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort B: Ixazomib 2 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled Placebo
n=3 participants at risk
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 participants at risk
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 participants at risk
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Pooled Placebo
n=3 participants at risk
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort A: Ixazomib 0.5 mg
n=5 participants at risk
Ixazomib 0.5 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
Cohort B: Ixazomib 2 mg
n=4 participants at risk
Ixazomib 2 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle from Cycle 1 to Cycle 3.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pyuria
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
33.3%
1/3 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
33.3%
1/3 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
40.0%
2/5 • Number of events 2 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
1/5 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
1/4 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
33.3%
1/3 • Number of events 1 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/5 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/4 • All AEs that started after the first dose of study drug up to Day 168 (study completion)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER