Trial Outcomes & Findings for The Effect of Ixazomib on the Latent HIV Reservoir (NCT NCT02946047)
NCT ID: NCT02946047
Last Updated: 2022-01-06
Results Overview
Number of treatment-emergent adverse events experienced by subjects as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
7 months
Results posted on
2022-01-06
Participant Flow
Participant milestones
| Measure |
Ixazomib 1 mg
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
7
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ixazomib 1 mg
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ixazomib 1 mg
n=4 Participants
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
n=3 Participants
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
n=3 Participants
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
n=7 Participants
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
n=4 Participants
|
49.3 years
n=3 Participants
|
51.0 years
n=3 Participants
|
49.0 years
n=7 Participants
|
51.0 years
n=17 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=17 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=7 Participants
|
7 participants
n=17 Participants
|
PRIMARY outcome
Timeframe: 7 monthsNumber of treatment-emergent adverse events experienced by subjects as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Outcome measures
| Measure |
Ixazomib 1 mg
n=4 Participants
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
n=3 Participants
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
n=3 Participants
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
n=7 Participants
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
HIV copies per million CD4 T cells
Outcome measures
| Measure |
Ixazomib 1 mg
n=4 Participants
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
n=3 Participants
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
n=3 Participants
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
n=7 Participants
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
Cell Associated HIV DNA in CD4 T Cell Subsets
Baseline
|
378 copies per million
Interval 208.0 to 837.0
|
626 copies per million
Interval 54.0 to 1385.0
|
664.8 copies per million
Interval 130.0 to 1014.0
|
416 copies per million
Interval 39.0 to 988.0
|
|
Cell Associated HIV DNA in CD4 T Cell Subsets
24 weeks
|
394 copies per million
Interval 137.0 to 812.0
|
425 copies per million
Interval 45.0 to 1715.0
|
624 copies per million
Interval 98.0 to 1125.0
|
481 copies per million
Interval 24.0 to 846.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
Infectious units per million CD4 T cells
Outcome measures
| Measure |
Ixazomib 1 mg
n=4 Participants
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
n=3 Participants
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
n=3 Participants
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
n=7 Participants
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
Culturable HIV by Quantitative Viral Outgrowth Assay
Baseline
|
0.49 units per million
Interval 0.15 to 1.23
|
0.30 units per million
Interval 0.14 to 1.6
|
0.62 units per million
Interval 0.3 to 2.12
|
1.54 units per million
Interval 0.15 to 2.95
|
|
Culturable HIV by Quantitative Viral Outgrowth Assay
24 weeks
|
0.30 units per million
Interval 0.3 to 0.66
|
0.48 units per million
Interval 0.1 to 0.65
|
0.82 units per million
Interval 0.81 to 1.07
|
1.31 units per million
Interval 0.1 to 2.58
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
Cells per microliter
Outcome measures
| Measure |
Ixazomib 1 mg
n=4 Participants
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
n=3 Participants
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
n=3 Participants
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
n=7 Participants
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
Absolute CD4 T Cell Count
Baseline
|
724 cells/mmˆ(3)
Interval 676.0 to 830.0
|
914 cells/mmˆ(3)
Interval 790.0 to 968.0
|
1130 cells/mmˆ(3)
Interval 1029.0 to 1240.0
|
735 cells/mmˆ(3)
Interval 680.0 to 770.0
|
|
Absolute CD4 T Cell Count
24 weeks
|
714 cells/mmˆ(3)
Interval 696.0 to 735.0
|
809 cells/mmˆ(3)
Interval 771.0 to 813.0
|
765 cells/mmˆ(3)
Interval 676.0 to 825.0
|
632 cells/mmˆ(3)
Interval 548.0 to 768.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
Cells per microliter
Outcome measures
| Measure |
Ixazomib 1 mg
n=4 Participants
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
n=3 Participants
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
n=3 Participants
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
n=7 Participants
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
Absolute CD8 T Cell Count
24 weeks
|
387 cells/mmˆ(3)
Interval 337.0 to 428.0
|
885 cells/mmˆ(3)
Interval 624.0 to 888.0
|
689 cells/mmˆ(3)
Interval 573.0 to 723.0
|
416 cells/mmˆ(3)
Interval 332.0 to 486.0
|
|
Absolute CD8 T Cell Count
Baseline
|
508 cells/mmˆ(3)
Interval 504.0 to 810.0
|
803 cells/mmˆ(3)
Interval 716.0 to 834.0
|
1014 cells/mmˆ(3)
Interval 868.0 to 1208.0
|
573 cells/mmˆ(3)
Interval 405.0 to 712.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: 24 week data for 1 participant in the Ixazomib 1 mg arms was not collected or analyzed
CD4/CD8 T cell count ratio
Outcome measures
| Measure |
Ixazomib 1 mg
n=4 Participants
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
n=3 Participants
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
n=3 Participants
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
n=7 Participants
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
CD4/CD8 Ratio
Baseline
|
1.45 ratio
Interval 1.1 to 1.67
|
1.14 ratio
Interval 0.95 to 1.38
|
1.28 ratio
Interval 1.04 to 1.31
|
1.58 ratio
Interval 1.15 to 1.82
|
|
CD4/CD8 Ratio
24 weeks
|
1.84 ratio
Interval 1.64 to 2.24
|
0.92 ratio
Interval 0.87 to 1.57
|
1.17 ratio
Interval 1.01 to 1.42
|
1.75 ratio
Interval 1.42 to 2.09
|
Adverse Events
Ixazomib 1 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ixazomib 2 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ixazomib 3 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ixazomib 4 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ixazomib 1 mg
n=4 participants at risk
Cohort A: Patients will receive ixazomib 1mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 1 MG: 1 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 1 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 2 mg
n=3 participants at risk
Cohort B: Patients will receive ixazomib 2mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 2 MG: 2mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 2 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 3 mg
n=3 participants at risk
Cohort C: Patients will receive ixazomib 3 mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 3 MG: 3 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 3 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
Ixazomib 4 mg
n=7 participants at risk
Cohort D: Patients will receive ixazomib 4mg 3 times monthly for 12 weeks, then weekly for 12 weeks.
Ixazomib 4 MG: 4 mg on days 1, 8 and 15 for three 28 days cycles, then be reviewed by DSMB and based upon their recommendation patients will receive ixazomib once weekly for 12 weeks or ixazomib 4 mg on days 1, 8 and 15 for three 28 days cycles. Visits 3-15 will have a window of ± 3 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/7 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
|
General disorders
Edema Limbs
|
0.00%
0/4 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/7 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/7 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/7 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/7 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/7 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
|
Skin and subcutaneous tissue disorders
Rash, maculopapular
|
0.00%
0/4 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
|
General disorders
Infection
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/3 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
0.00%
0/7 • Adverse events were collected from baseline to end of study for a total of approximately 7 months on all participatns.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place