Trial Outcomes & Findings for Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma (NCT NCT02633059)
NCT ID: NCT02633059
Last Updated: 2024-09-19
Results Overview
Defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). DLT is graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
28 days
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Phase 1: Dose Level 0
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
4
|
18
|
|
Overall Study
COMPLETED
|
4
|
6
|
4
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1: Dose Level 0
n=4 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
n=7 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
n=4 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
n=18 Participants
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 6.60 • n=99 Participants
|
60.9 years
STANDARD_DEVIATION 8.69 • n=107 Participants
|
63.0 years
STANDARD_DEVIATION 12.03 • n=206 Participants
|
65.0 years
STANDARD_DEVIATION 7.65 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 8.19 • n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
ECOG Performance Status (PS)
0
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
ECOG Performance Status (PS)
1
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
ECOG Performance Status (PS)
2
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Mayo Clinic Stratification for Myeloma and Risk-Adapted Therapy (mSMART)
High Risk
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Mayo Clinic Stratification for Myeloma and Risk-Adapted Therapy (mSMART)
Standard Risk
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
What was the International Staging System myeloma stage?
Stage I
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
What was the International Staging System myeloma stage?
Stage II
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
What was the International Staging System myeloma stage?
Stage III
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
What was the International Staging System myeloma stage?
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
What was the International Staging System myeloma stage?
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Revised International Staging System
I
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Revised International Staging System
II
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Revised International Staging System
III
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Serum Creatinine (mg/dL)
|
0.8 mg/dL
STANDARD_DEVIATION 0.24 • n=99 Participants
|
1.1 mg/dL
STANDARD_DEVIATION 0.60 • n=107 Participants
|
0.9 mg/dL
STANDARD_DEVIATION 0.19 • n=206 Participants
|
1.2 mg/dL
STANDARD_DEVIATION 0.53 • n=7 Participants
|
1.1 mg/dL
STANDARD_DEVIATION 0.49 • n=31 Participants
|
|
Serum LDH (U/L)
|
201.3 (U/L)
STANDARD_DEVIATION 43.94 • n=99 Participants
|
198.7 (U/L)
STANDARD_DEVIATION 162.89 • n=107 Participants
|
349.0 (U/L)
STANDARD_DEVIATION 239.56 • n=206 Participants
|
259.6 (U/L)
STANDARD_DEVIATION 119.45 • n=7 Participants
|
249.5 (U/L)
STANDARD_DEVIATION 144.49 • n=31 Participants
|
|
Parameter for response
Serum M-spike >= 1 g/dL and urine M-spike >= 200 mg/24 hours
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Parameter for response
Serum M-spike >= 1 g/dL only
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Parameter for response
Urine M-spike >= 200 mg/24 hours only
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Parameter for response
Serum immunoglobulin free light chain >= 10 mg/dL
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
(If serum M-spike), parameter followed for serum M-spike
SPEP measurement
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
(If serum M-spike), parameter followed for serum M-spike
Missing
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Disease category
Relapsed
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Disease category
Refractory
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Prior transplant related to this cancer
Yes
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Prior transplant related to this cancer
No
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 28 daysDefined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). DLT is graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
Phase 1: Dose Level 0
n=4 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
n=7 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
n=4 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
n=18 Participants
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
The Number of Participants Who Experienced Dose Limiting Toxicities. Maximum Tolerated Dose (MTD) of Ixazomib Citrate and Idasanutlin in Combination With Dexamethasone (Phase I)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsResponses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
Outcome measures
| Measure |
Phase 1: Dose Level 0
n=22 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
PR
|
2 Participants
|
—
|
—
|
—
|
|
Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
SD
|
6 Participants
|
—
|
—
|
—
|
|
Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
NA
|
14 Participants
|
—
|
—
|
—
|
|
Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
CR
|
0 Participants
|
—
|
—
|
—
|
|
Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
VGPR
|
0 Participants
|
—
|
—
|
—
|
|
Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
sCR
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 days after the last dose of study treatment, up to 3 yearsOverall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
Outcome measures
| Measure |
Phase 1: Dose Level 0
n=4 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
n=7 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
n=4 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 3+ Adverse Events, Regardless of Attribution
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 3+ Adverse Events, At Least Possibly Related
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 4+ Adverse Events, Regardless of Attribution
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 4+ Adverse Events, At Least Possibly Related
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 5 Adverse Events, Regardless of Attribution
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 5 Adverse Events, At Least Possibly Related
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 3+ Heme Adverse Events, Regardless of Attribution
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 3+ Heme Adverse Events, At Least Possibly Related
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 4+ Heme Adverse Events, Regardless of Attribution
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 4+ Heme Adverse Events, At Least Possibly Related
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 5 Heme Adverse Events, Regardless of Attribution
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 5 Heme Adverse Events, At Least Possibly Related
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 3+ Non-heme Adverse Events, Regardless of Attribution
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 3+ Non-heme Adverse Events, At Least Possibly Related
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 4+ Non-heme Adverse Events, Regardless of Attribution
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 4+ Non-heme Adverse Events, At Least Possibly Related
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 5 Non-heme Adverse Events, Regardless of Attribution
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Grade 5 Non-heme Adverse Events, At Least Possibly Related
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsPopulation: Participants who had adverse events fitting the criteria
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
Outcome measures
| Measure |
Phase 1: Dose Level 0
n=17 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 3+ Adverse Events, Regardless of Attribution
|
14 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 3+ Adverse Events, At Least Possibly Related
|
13 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 4+ Adverse Events, Regardless of Attribution
|
10 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 4+ Adverse Events, At Least Possibly Related
|
9 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 5 Adverse Events, Regardless of Attribution
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 5 Adverse Events, At Least Possibly Related
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 3+ Heme Adverse Events, Regardless of Attribution
|
13 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 3+ Heme Adverse Events, At Least Possibly Related
|
13 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 4+ Heme Adverse Events, Regardless of Attribution
|
9 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 4+ Heme Adverse Events, At Least Possibly Related
|
9 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 5 Heme Adverse Events, Regardless of Attribution
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 5 Heme Adverse Events, At Least Possibly Related
|
0 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 3+ Non-heme Adverse Events, Regardless of Attribution
|
5 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 3+ Non-heme Adverse Events, At Least Possibly Related
|
3 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 4+ Non-heme Adverse Events, Regardless of Attribution
|
4 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 4+ Non-heme Adverse Events, At Least Possibly Related
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 5 Non-heme Adverse Events, Regardless of Attribution
|
2 Participants
|
—
|
—
|
—
|
|
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
Grade 5 Non-heme Adverse Events, At Least Possibly Related
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsThe distribution of overall survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase 1: Dose Level 0
n=22 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Overall Survival (Phase II)
|
21.0 months
Interval 10.4 to
Upper limit not reached due to insufficient number of participants with events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 yearsThe distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase 1: Dose Level 0
n=22 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Progression Free Survival (Phase II)
|
3.8 months
Interval 2.2 to 7.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe rate of CR will be estimated by the number of patients with a sCR or CR or divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportions will be calculated.
Outcome measures
| Measure |
Phase 1: Dose Level 0
n=22 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Rate of Complete Response (CR) (Phase II)
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe rate of PR will be estimated by the number of patients with a VGPR or PR divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportions will be calculated.
Outcome measures
| Measure |
Phase 1: Dose Level 0
n=22 Participants
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Rate of Partial Response (PR) (Phase II)
|
2 Participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 6 monthsEffect of inhibition of mdm2 will be assessed by measuring MIC levels. MIC levels at each time point and changes after treatment will be both graphically and quantitatively summarized and explored. Changes from baseline will be evaluated using Wilcoxon's signed rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 monthsImpact of MDM2 inhibition on activation of p53 and clonal selection examined using gene expression profiling and exome sequencing
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 monthsPotential biomarkers associated with response will be assessed in an exploratory manner. Potential markers will be determined using gene expression profiling. The correlation between potential biomarkers and response (responders vs. non-responders) will be evaluated using Fisher's exact and Wilcoxon rank sum tests, where appropriate.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1: Dose Level 0
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 1: Dose Level 1
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 1: Dose Level 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 2: Dose Level 1
Serious events: 6 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1: Dose Level 0
n=4 participants at risk
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
n=7 participants at risk
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
n=4 participants at risk
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
n=17 participants at risk
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
General disorders
Pain
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
11.8%
2/17 • Number of events 2 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
11.8%
2/17 • Number of events 2 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
Other adverse events
| Measure |
Phase 1: Dose Level 0
n=4 participants at risk
Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 1
n=7 participants at risk
Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
Phase 1: Dose Level 2
n=4 participants at risk
Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
|
Phase 2: Dose Level 1
n=17 participants at risk
Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
4/4 • Number of events 10 • Up to 3 years
|
100.0%
7/7 • Number of events 26 • Up to 3 years
|
100.0%
4/4 • Number of events 10 • Up to 3 years
|
82.4%
14/17 • Number of events 58 • Up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
28.6%
2/7 • Number of events 7 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
35.3%
6/17 • Number of events 18 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
57.1%
4/7 • Number of events 9 • Up to 3 years
|
75.0%
3/4 • Number of events 6 • Up to 3 years
|
47.1%
8/17 • Number of events 15 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
57.1%
4/7 • Number of events 6 • Up to 3 years
|
100.0%
4/4 • Number of events 5 • Up to 3 years
|
58.8%
10/17 • Number of events 21 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
28.6%
2/7 • Number of events 2 • Up to 3 years
|
100.0%
4/4 • Number of events 4 • Up to 3 years
|
35.3%
6/17 • Number of events 8 • Up to 3 years
|
|
General disorders
Edema limbs
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 6 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
85.7%
6/7 • Number of events 15 • Up to 3 years
|
75.0%
3/4 • Number of events 5 • Up to 3 years
|
58.8%
10/17 • Number of events 50 • Up to 3 years
|
|
General disorders
Fever
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 3 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
11.8%
2/17 • Number of events 4 • Up to 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • Up to 3 years
|
71.4%
5/7 • Number of events 12 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
23.5%
4/17 • Number of events 16 • Up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
17.6%
3/17 • Number of events 5 • Up to 3 years
|
|
Investigations
Neutrophil count decreased
|
75.0%
3/4 • Number of events 9 • Up to 3 years
|
71.4%
5/7 • Number of events 8 • Up to 3 years
|
75.0%
3/4 • Number of events 6 • Up to 3 years
|
52.9%
9/17 • Number of events 19 • Up to 3 years
|
|
Investigations
Platelet count decreased
|
100.0%
4/4 • Number of events 14 • Up to 3 years
|
85.7%
6/7 • Number of events 22 • Up to 3 years
|
100.0%
4/4 • Number of events 10 • Up to 3 years
|
88.2%
15/17 • Number of events 59 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
75.0%
3/4 • Number of events 10 • Up to 3 years
|
71.4%
5/7 • Number of events 13 • Up to 3 years
|
75.0%
3/4 • Number of events 6 • Up to 3 years
|
70.6%
12/17 • Number of events 24 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 6 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 5 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 1 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
50.0%
2/4 • Number of events 7 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
71.4%
5/7 • Number of events 17 • Up to 3 years
|
50.0%
2/4 • Number of events 3 • Up to 3 years
|
47.1%
8/17 • Number of events 51 • Up to 3 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 6 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 2 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 6 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/7 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
5.9%
1/17 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up to 3 years
|
14.3%
1/7 • Number of events 6 • Up to 3 years
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/17 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place