Trial Outcomes & Findings for Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) (NCT NCT02515630)
NCT ID: NCT02515630
Last Updated: 2023-06-18
Results Overview
The percentage of subjects who became transfusion independent for ≥ 12 weeks at any time on study. A subject was considered transfusion independent on study if no RBC transfusion occurred in any 12-week period during the 24-week treatment period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
From baseline to Week 24
Results posted on
2023-06-18
Participant Flow
This study enrolled transfusion-dependent myelofibrosis patients at oncology centers in the United States and Canada. Following completion of the 24-week study period, patients who were benefiting had the option to continue maintenance momelotinib treatment in an open-label extension study (NCT02124746).
Participant milestones
| Measure |
Momelotinib (MMB)
Subjects received oral MMB at a starting dose of 200 mg once daily for 24 weeks (± 7 days) on study.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Momelotinib (MMB)
Subjects received oral MMB at a starting dose of 200 mg once daily for 24 weeks (± 7 days) on study.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Baseline characteristics by cohort
| Measure |
Transfusion Independence Responders
n=14 Participants
Subjects who became transfusion independent by Week 24
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
72 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
70 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Spleen Volume
|
2132.2 cm^3
STANDARD_DEVIATION 1439.5 • n=5 Participants
|
2018.1 cm^3
STANDARD_DEVIATION 1248.5 • n=7 Participants
|
2057.1 cm^3
STANDARD_DEVIATION 1299.8 • n=5 Participants
|
|
Total Symptom Score
|
19.00 units on a scale
STANDARD_DEVIATION 16.14 • n=5 Participants
|
21.73 units on a scale
STANDARD_DEVIATION 13.97 • n=7 Participants
|
20.73 units on a scale
STANDARD_DEVIATION 14.65 • n=5 Participants
|
|
RBC Units Transfused within 8 weeks prior to Enrollment
|
5 Units of red blood cell
STANDARD_DEVIATION 1.9 • n=5 Participants
|
7 Units of red blood cell
STANDARD_DEVIATION 2.2 • n=7 Participants
|
6 Units of red blood cell
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Hepcidin
|
22.0 nM
n=5 Participants
|
42.4 nM
n=7 Participants
|
36.6 nM
n=5 Participants
|
|
Serum iron
|
96.0 ug/dL
n=5 Participants
|
127.0 ug/dL
n=7 Participants
|
119.0 ug/dL
n=5 Participants
|
|
Hemoglobin
|
8.5 g/dL
n=5 Participants
|
7.8 g/dL
n=7 Participants
|
8.0 g/dL
n=5 Participants
|
|
Total iron binding capacity
|
214.5 ug/dL
n=5 Participants
|
201.0 ug/dL
n=7 Participants
|
205.0 ug/dL
n=5 Participants
|
|
Reticulocytes
|
0.096 cells*10^6/uL
n=5 Participants
|
0.067 cells*10^6/uL
n=7 Participants
|
0.071 cells*10^6/uL
n=5 Participants
|
|
Reticulocytes/erythrocytes
|
3.5 %
n=5 Participants
|
2.2 %
n=7 Participants
|
2.4 %
n=5 Participants
|
|
Erythropoietin
|
238.7 mIU/mL
n=5 Participants
|
88.1 mIU/mL
n=7 Participants
|
109.8 mIU/mL
n=5 Participants
|
|
Erythrocytes
|
3.0 cells*10^6/uL
n=5 Participants
|
2.8 cells*10^6/uL
n=7 Participants
|
2.9 cells*10^6/uL
n=5 Participants
|
|
Hematocrit
|
27.5 %
n=5 Participants
|
24.0 %
n=7 Participants
|
25.0 %
n=5 Participants
|
|
Ferritin
|
605.9 ng/mL
n=5 Participants
|
1259.4 ng/mL
n=7 Participants
|
1008.9 ng/mL
n=5 Participants
|
|
Soluble transferrin receptor
|
2.5 mg/L
n=5 Participants
|
1.3 mg/L
n=7 Participants
|
1.6 mg/L
n=5 Participants
|
|
Transferrin saturation
|
43.0 %
n=5 Participants
|
56.5 %
n=7 Participants
|
53.0 %
n=5 Participants
|
|
Unsaturated iron binding capacity
|
113.5 ug/dL
n=5 Participants
|
81.0 ug/dL
n=7 Participants
|
92.0 ug/dL
n=5 Participants
|
|
Platelets
|
190.5 cells*10^3/uL
n=5 Participants
|
134.0 cells*10^3/uL
n=7 Participants
|
146.0 cells*10^3/uL
n=5 Participants
|
|
Leukocytes
|
6.4 cells*10^3/uL
n=5 Participants
|
8.5 cells*10^3/uL
n=7 Participants
|
6.4 cells*10^3/uL
n=5 Participants
|
|
Blasts
|
0 %
n=5 Participants
|
2.0 %
n=7 Participants
|
2.0 %
n=5 Participants
|
|
Liver Iron Content
|
2.4 mg/g
n=5 Participants
|
4.2 mg/g
n=7 Participants
|
3.5 mg/g
n=5 Participants
|
|
%pSTAT Stimulated CD3+/4+ T cell
|
85.1 %
n=5 Participants
|
77.8 %
n=7 Participants
|
79.8 %
n=5 Participants
|
|
%pSTAT %tSTAT Stimulated CD3+/4+ T cell Ratio
|
0.9 ratio
n=5 Participants
|
0.8 ratio
n=7 Participants
|
0.9 ratio
n=5 Participants
|
|
C-Reactive Protein
|
0.7 mg/dL
n=5 Participants
|
1.8 mg/dL
n=7 Participants
|
1.2 mg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 24Population: Assessed in the Safety Analysis Set, which includes all subjects who received ≥ 1 dose of momelotinib. Note that 6 subjects discontinued prior to Week 12 and could not be evaluated over the minimum period required for assessment of the endpoint (12 weeks).
The percentage of subjects who became transfusion independent for ≥ 12 weeks at any time on study. A subject was considered transfusion independent on study if no RBC transfusion occurred in any 12-week period during the 24-week treatment period.
Outcome measures
| Measure |
Total
n=41 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
Subjects who did not become transfusion independent by Week 24
|
Total
All enrolled subjects
|
|---|---|---|---|
|
Transfusion Independence Response by Week 24
|
34.1 percentage of subjects
Interval 22.0 to 48.1
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Assessed in the Safety Analysis Set, which includes all subjects who received ≥ 1 dose of momelotinib. Note that 3 subjects discontinued prior to Week 8 and could not be evaluated over the minimum period required for assessment of the endpoint (8 weeks).
The percentage of subjects who became transfusion independent for ≥ 8 weeks, defined as no RBC transfusions for at least an 8-week period at any time on study.
Outcome measures
| Measure |
Total
n=41 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
Subjects who did not become transfusion independent by Week 24
|
Total
All enrolled subjects
|
|---|---|---|---|
|
Transfusion Response Rate by Week 24
|
39.0 percentage of subjects
Interval 26.2 to 53.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Week 24Population: Assessed in the Safety Analysis Set, which includes all subjects who received ≥ 1 dose of momelotinib. Note that spleen volume at Week 24 was not available for 15 subjects.
The percentage of subjects who achieved a ≥ 35% reduction in spleen volume from baseline as measured by MRI at Week 24.
Outcome measures
| Measure |
Total
n=41 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
Subjects who did not become transfusion independent by Week 24
|
Total
All enrolled subjects
|
|---|---|---|---|
|
Splenic Response Rate at Week 24
|
12.2 percentage of subjects
Interval 4.9 to 23.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Week 24Population: There were 3 subjects with missing TSS at baseline who were excluded from the analysis. Note that of the 38 subjects evaluated, 17 were missing Week 24 TSS assessments.
The percentage of subjects achieving a ≥ 50% reduction from baseline in TSS at Week 24, as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPNSAF TSS) diary. Total symptom score was assessed using the modified MPN-SAF TSS Version 2, an 8-item questionnaire developed to assess symptom burden and quality of life in patients with MPN. The modified MPN-SAF TSS contained 8 questions, 7 of which were summed to generate the score (the included questions related to tiredness, early satiety, abdominal discomfort, night sweats, itching, bone pain, and pain under the ribs on the left side). Each question is scored on a scale of 0-10, where higher numbers indicate more severe symptoms. For this study, the TSS scale ranges from 0 to 70. The questionnaire was completed daily on an electronic diary device.
Outcome measures
| Measure |
Total
n=38 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
Subjects who did not become transfusion independent by Week 24
|
Total
All enrolled subjects
|
|---|---|---|---|
|
Response Rate in Total Symptom Score (TSS) at Week 24
|
15.8 percentage of subjects
Interval 7.1 to 28.8
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20 and 24Hepcidin daily change (in nM) was calculated as the predose value subtracted from the 6 hours postdose value at each study visit. Daily hepcidin change at the baseline visit was the difference between 2 values obtained 6 hours apart. No momelotinib was administered on that day.
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Baseline
|
-1.7 nM
Interval -2.1 to 4.7
|
0.1 nM
Interval -3.3 to 4.5
|
0.0 nM
Interval -3.3 to 4.6
|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Day 1
|
-4.8 nM
Interval -10.2 to -1.4
|
-11.2 nM
Interval -16.0 to -5.8
|
-8.6 nM
Interval -14.4 to -3.3
|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Week 2
|
-4.9 nM
Interval -9.1 to -0.4
|
-6.7 nM
Interval -11.3 to -1.2
|
-6.3 nM
Interval -9.2 to -0.7
|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Week 4
|
-2.6 nM
Interval -8.5 to 0.1
|
-7.4 nM
Interval -9.6 to -0.9
|
-5.4 nM
Interval -9.6 to 0.1
|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Week 8
|
-2.9 nM
Interval -7.3 to -0.9
|
-5.2 nM
Interval -17.7 to 2.1
|
-4.4 nM
Interval -10.9 to -0.6
|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Week 12
|
-1.4 nM
Interval -6.8 to 0.7
|
-5.7 nM
Interval -8.7 to -0.9
|
-4.1 nM
Interval -8.4 to 0.5
|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Week 16
|
-0.4 nM
Interval -6.4 to 0.7
|
-4.3 nM
Interval -15.1 to 1.9
|
-2.7 nM
Interval -8.5 to 1.1
|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Week 20
|
0.0 nM
Interval -6.6 to 4.2
|
-7.8 nM
Interval -12.5 to -1.9
|
-5.3 nM
Interval -9.0 to 1.5
|
|
Change in Markers of Iron Metabolism and Anemia - Change From Baseline in Hepcidin Daily Change
Week 24
|
-1.0 nM
Interval -4.6 to 0.1
|
-1.8 nM
Interval -7.8 to 0.1
|
-1.4 nM
Interval -6.0 to 0.1
|
SECONDARY outcome
Timeframe: At baseline, Day 1, Weeks 2, 4, 8, 12, 16, 20 and 24Median hepcidin at trough was assessed predose at each study visit.
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Baseline
|
22.0 nM
Interval 9.6 to 33.9
|
42.4 nM
Interval 27.4 to 64.9
|
36.6 nM
Interval 18.6 to 48.5
|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Day 1
|
19.7 nM
Interval 5.5 to 30.8
|
43.7 nM
Interval 29.9 to 58.7
|
36.5 nM
Interval 22.4 to 48.0
|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Week 2
|
25.1 nM
Interval 14.6 to 29.7
|
52.1 nM
Interval 37.4 to 61.2
|
38.4 nM
Interval 25.8 to 57.6
|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Week 24
|
15.5 nM
Interval 4.9 to 28.8
|
51.5 nM
Interval 27.9 to 60.2
|
28.4 nM
Interval 14.2 to 45.2
|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Week 4
|
19.8 nM
Interval 13.7 to 30.8
|
46.4 nM
Interval 39.1 to 57.1
|
37.6 nM
Interval 19.8 to 51.9
|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Week 8
|
16.6 nM
Interval 10.1 to 29.2
|
51.7 nM
Interval 39.9 to 59.4
|
35.5 nM
Interval 16.9 to 52.7
|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Week 12
|
21.3 nM
Interval 10.9 to 30.4
|
44.7 nM
Interval 23.3 to 53.9
|
30.4 nM
Interval 15.6 to 44.8
|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Week 16
|
16.9 nM
Interval 7.1 to 29.0
|
51.9 nM
Interval 43.7 to 62.9
|
34.5 nM
Interval 17.1 to 51.9
|
|
Change in Markers of Iron Metabolism and Anemia - Trough Hepcidin
Week 20
|
13.4 nM
Interval 4.5 to 27.4
|
44.2 nM
Interval 31.5 to 49.7
|
27.5 nM
Interval 13.4 to 44.3
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in serum iron, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Serum Iron
Week 12
|
3.0 % Change from baseline
Interval -25.2 to 73.2
|
14.3 % Change from baseline
Interval 3.1 to 35.1
|
12.8 % Change from baseline
Interval -7.9 to 39.4
|
|
Change in Markers of Iron Metabolism and Anemia - Serum Iron
Week 16
|
-15.5 % Change from baseline
Interval -20.3 to 56.6
|
16.5 % Change from baseline
Interval -19.3 to 30.7
|
8.9 % Change from baseline
Interval -19.4 to 30.7
|
|
Change in Markers of Iron Metabolism and Anemia - Serum Iron
Week 20
|
-11.1 % Change from baseline
Interval -17.8 to 41.7
|
9.9 % Change from baseline
Interval -7.4 to 28.1
|
1.9 % Change from baseline
Interval -17.8 to 34.6
|
|
Change in Markers of Iron Metabolism and Anemia - Serum Iron
Week 2
|
4.5 % Change from baseline
Interval -14.6 to 73.2
|
5.9 % Change from baseline
Interval -10.3 to 31.0
|
5.9 % Change from baseline
Interval -11.8 to 39.6
|
|
Change in Markers of Iron Metabolism and Anemia - Serum Iron
Week 4
|
39.8 % Change from baseline
Interval 1.8 to 108.1
|
5.7 % Change from baseline
Interval -16.2 to 33.3
|
13.3 % Change from baseline
Interval -12.7 to 57.8
|
|
Change in Markers of Iron Metabolism and Anemia - Serum Iron
Week 8
|
9.3 % Change from baseline
Interval -23.6 to 44.0
|
5.4 % Change from baseline
Interval -15.6 to 42.0
|
6.4 % Change from baseline
Interval -18.2 to 44.0
|
|
Change in Markers of Iron Metabolism and Anemia - Serum Iron
Week 24
|
-8.1 % Change from baseline
Interval -20.4 to 45.1
|
-5.1 % Change from baseline
Interval -24.3 to 31.1
|
-6.6 % Change from baseline
Interval -22.9 to 37.4
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in hemoglobin, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Hemoglobin
Week 12
|
15.6 % Change in from baseline
Interval 5.3 to 25.3
|
4.5 % Change in from baseline
Interval -12.5 to 13.4
|
7.5 % Change in from baseline
Interval -4.8 to 17.4
|
|
Change in Markers of Iron Metabolism and Anemia - Hemoglobin
Week 8
|
12.4 % Change in from baseline
Interval 4.8 to 27.7
|
0.4 % Change in from baseline
Interval -7.7 to 14.2
|
5.6 % Change in from baseline
Interval -6.3 to 19.1
|
|
Change in Markers of Iron Metabolism and Anemia - Hemoglobin
Week 16
|
12.3 % Change in from baseline
Interval 4.8 to 32.9
|
0.6 % Change in from baseline
Interval -9.5 to 15.0
|
10.2 % Change in from baseline
Interval -6.3 to 19.7
|
|
Change in Markers of Iron Metabolism and Anemia - Hemoglobin
Week 20
|
13.1 % Change in from baseline
Interval 5.3 to 28.9
|
6.9 % Change in from baseline
Interval -7.1 to 17.3
|
7.4 % Change in from baseline
Interval -3.9 to 17.9
|
|
Change in Markers of Iron Metabolism and Anemia - Hemoglobin
Week 24
|
10.0 % Change in from baseline
Interval -2.1 to 29.4
|
5.8 % Change in from baseline
Interval -1.3 to 14.4
|
7.9 % Change in from baseline
Interval -1.4 to 17.6
|
|
Change in Markers of Iron Metabolism and Anemia - Hemoglobin
Week 2
|
12.8 % Change in from baseline
Interval 0.0 to 20.3
|
9.2 % Change in from baseline
Interval 0.0 to 26.3
|
9.9 % Change in from baseline
Interval 0.0 to 20.4
|
|
Change in Markers of Iron Metabolism and Anemia - Hemoglobin
Week 4
|
8.3 % Change in from baseline
Interval 1.4 to 15.9
|
6.3 % Change in from baseline
Interval -1.2 to 20.6
|
6.9 % Change in from baseline
Interval -1.2 to 20.6
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in total iron binding capacity, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity
Week 8
|
4.9 % Change from baseline
Interval -2.7 to 10.3
|
0.6 % Change from baseline
Interval -7.4 to 13.7
|
2.4 % Change from baseline
Interval -6.6 to 11.5
|
|
Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity
Week 12
|
6.6 % Change from baseline
Interval -3.9 to 12.6
|
2.4 % Change from baseline
Interval -5.9 to 20.2
|
6.6 % Change from baseline
Interval -5.5 to 15.1
|
|
Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity
Week 16
|
4.5 % Change from baseline
Interval -3.2 to 9.8
|
1.5 % Change from baseline
Interval -10.0 to 14.2
|
3.6 % Change from baseline
Interval -5.3 to 11.3
|
|
Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity
Week 24
|
7.3 % Change from baseline
Interval 3.6 to 15.8
|
0.5 % Change from baseline
Interval -8.4 to 10.7
|
5.5 % Change from baseline
Interval -5.9 to 13.0
|
|
Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity
Week 2
|
4.5 % Change from baseline
Interval 0.4 to 13.6
|
2.0 % Change from baseline
Interval -5.5 to 8.9
|
2.8 % Change from baseline
Interval -1.6 to 10.1
|
|
Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity
Week 4
|
6.7 % Change from baseline
Interval -2.5 to 15.7
|
1.5 % Change from baseline
Interval -9.6 to 10.7
|
2.2 % Change from baseline
Interval -5.6 to 11.0
|
|
Change in Markers of Iron Metabolism and Anemia - Total Iron Binding Capacity
Week 20
|
15.5 % Change from baseline
Interval 3.4 to 22.1
|
5.5 % Change from baseline
Interval -11.6 to 15.4
|
10.6 % Change from baseline
Interval 1.6 to 17.2
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in reticulocytes, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes
Week 2
|
33.6 % Change from baseline
Interval -6.7 to 67.5
|
-9.6 % Change from baseline
Interval -26.0 to 26.4
|
2.9 % Change from baseline
Interval -23.6 to 36.2
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes
Week 16
|
31.2 % Change from baseline
Interval -22.1 to 58.5
|
8.8 % Change from baseline
Interval -24.0 to 35.5
|
18.3 % Change from baseline
Interval -23.1 to 45.6
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes
Week 20
|
34.0 % Change from baseline
Interval -35.6 to 70.4
|
7.7 % Change from baseline
Interval -48.6 to 27.7
|
16.3 % Change from baseline
Interval -44.8 to 48.1
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes
Week 4
|
11.8 % Change from baseline
Interval 4.0 to 40.7
|
5.5 % Change from baseline
Interval -32.7 to 46.4
|
7.5 % Change from baseline
Interval -29.3 to 43.5
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes
Week 8
|
30.0 % Change from baseline
Interval 13.2 to 35.0
|
-16.0 % Change from baseline
Interval -30.6 to 28.4
|
15.6 % Change from baseline
Interval -24.5 to 31.0
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes
Week 12
|
15.8 % Change from baseline
Interval -6.3 to 45.1
|
-9.5 % Change from baseline
Interval -34.5 to 33.3
|
4.8 % Change from baseline
Interval -17.3 to 44.2
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes
Week 24
|
29.9 % Change from baseline
Interval 11.5 to 58.3
|
-0.6 % Change from baseline
Interval -32.0 to 67.8
|
24.1 % Change from baseline
Interval -12.0 to 58.4
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in reticulocytes/erythrocytes%, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes/Erythrocytes%
Week 20
|
2.2 % Change from baseline
Interval -34.3 to 21.4
|
14.6 % Change from baseline
Interval -43.8 to 46.2
|
11.1 % Change from baseline
Interval -42.1 to 46.2
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes/Erythrocytes%
Week 24
|
2.2 % Change from baseline
Interval -2.9 to 24.1
|
-7.8 % Change from baseline
Interval -34.2 to 72.6
|
-2.6 % Change from baseline
Interval -11.8 to 72.2
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes/Erythrocytes%
Week 2
|
30.0 % Change from baseline
Interval -16.7 to 42.6
|
-16.3 % Change from baseline
Interval -30.1 to 23.6
|
-8.0 % Change from baseline
Interval -28.1 to 36.4
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes/Erythrocytes%
Week 4
|
8.2 % Change from baseline
Interval -7.0 to 20.4
|
1.5 % Change from baseline
Interval -36.3 to 29.6
|
4.1 % Change from baseline
Interval -29.9 to 26.5
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes/Erythrocytes%
Week 8
|
12.4 % Change from baseline
Interval -5.6 to 33.3
|
-11.1 % Change from baseline
Interval -35.3 to 27.8
|
0.0 % Change from baseline
Interval -21.2 to 27.8
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes/Erythrocytes%
Week 12
|
3.6 % Change from baseline
Interval -11.1 to 16.7
|
0.0 % Change from baseline
Interval -31.6 to 42.3
|
0.0 % Change from baseline
Interval -29.4 to 42.3
|
|
Change in Markers of Iron Metabolism and Anemia - Reticulocytes/Erythrocytes%
Week 16
|
4.4 % Change from baseline
Interval -22.9 to 33.3
|
18.7 % Change from baseline
Interval -30.0 to 50.0
|
7.8 % Change from baseline
Interval -29.0 to 41.7
|
SECONDARY outcome
Timeframe: At Weeks 8 and 20Percent change in erythropoietin at Weeks 8 and 20. The baseline erythropoietin value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Erythropoietin
Week 8
|
-30.8 % Change from baseline
Interval -55.6 to -6.8
|
-8.1 % Change from baseline
Interval -47.7 to 31.3
|
-24.5 % Change from baseline
Interval -55.4 to 29.4
|
|
Change in Markers of Iron Metabolism and Anemia - Erythropoietin
Week 20
|
-45.0 % Change from baseline
Interval -63.4 to -2.0
|
8.5 % Change from baseline
Interval -16.2 to 82.9
|
-4.4 % Change from baseline
Interval -60.2 to 32.5
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in erythrocytes, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Erythrocytes
Week 24
|
-8.0 % Change from baseline
Interval -9.7 to 26.7
|
3.3 % Change from baseline
Interval -7.1 to 11.4
|
0.0 % Change from baseline
Interval -9.7 to 19.2
|
|
Change in Markers of Iron Metabolism and Anemia - Erythrocytes
Week 2
|
5.2 % Change from baseline
Interval 0.0 to 20.0
|
3.4 % Change from baseline
Interval -6.1 to 12.1
|
3.4 % Change from baseline
Interval -6.1 to 16.7
|
|
Change in Markers of Iron Metabolism and Anemia - Erythrocytes
Week 4
|
6.7 % Change from baseline
Interval -8.8 to 13.3
|
3.6 % Change from baseline
Interval -3.6 to 21.5
|
3.8 % Change from baseline
Interval -3.7 to 16.0
|
|
Change in Markers of Iron Metabolism and Anemia - Erythrocytes
Week 8
|
3.6 % Change from baseline
Interval -2.0 to 23.3
|
0.0 % Change from baseline
Interval -13.1 to 13.0
|
3.0 % Change from baseline
Interval -6.1 to 22.9
|
|
Change in Markers of Iron Metabolism and Anemia - Erythrocytes
Week 12
|
3.1 % Change from baseline
Interval -3.6 to 26.7
|
3.6 % Change from baseline
Interval -13.8 to 11.4
|
3.4 % Change from baseline
Interval -10.0 to 23.1
|
|
Change in Markers of Iron Metabolism and Anemia - Erythrocytes
Week 16
|
0.0 % Change from baseline
Interval -8.8 to 26.7
|
-6.9 % Change from baseline
Interval -9.2 to 6.5
|
-2.9 % Change from baseline
Interval -8.8 to 12.0
|
|
Change in Markers of Iron Metabolism and Anemia - Erythrocytes
Week 20
|
-3.3 % Change from baseline
Interval -12.0 to 26.7
|
-3.4 % Change from baseline
Interval -13.8 to 7.7
|
-3.4 % Change from baseline
Interval -12.1 to 12.2
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in hematocrit, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Hematocrit
Week 4
|
7.4 % Change from baseline
Interval -5.6 to 10.7
|
0.0 % Change from baseline
Interval -4.3 to 21.4
|
3.4 % Change from baseline
Interval -4.3 to 20.0
|
|
Change in Markers of Iron Metabolism and Anemia - Hematocrit
Week 8
|
11.1 % Change from baseline
Interval 3.6 to 25.9
|
-1.7 % Change from baseline
Interval -14.6 to 14.8
|
4.0 % Change from baseline
Interval -7.1 to 17.9
|
|
Change in Markers of Iron Metabolism and Anemia - Hematocrit
Week 12
|
7.1 % Change from baseline
Interval -3.1 to 30.8
|
1.8 % Change from baseline
Interval -13.0 to 14.8
|
3.6 % Change from baseline
Interval -8.0 to 18.2
|
|
Change in Markers of Iron Metabolism and Anemia - Hematocrit
Week 16
|
5.9 % Change from baseline
Interval -3.2 to 28.6
|
-4.2 % Change from baseline
Interval -8.3 to 8.2
|
3.8 % Change from baseline
Interval -7.7 to 10.7
|
|
Change in Markers of Iron Metabolism and Anemia - Hematocrit
Week 2
|
8.9 % Change from baseline
Interval -4.3 to 18.5
|
4.0 % Change from baseline
Interval -4.8 to 11.1
|
4.5 % Change from baseline
Interval -4.8 to 16.1
|
|
Change in Markers of Iron Metabolism and Anemia - Hematocrit
Week 20
|
7.1 % Change from baseline
Interval -3.2 to 26.9
|
0.0 % Change from baseline
Interval -12.0 to 4.3
|
0.0 % Change from baseline
Interval -7.9 to 12.8
|
|
Change in Markers of Iron Metabolism and Anemia - Hematocrit
Week 24
|
8.0 % Change from baseline
Interval -3.6 to 28.6
|
2.3 % Change from baseline
Interval -9.1 to 9.1
|
4.5 % Change from baseline
Interval -8.3 to 14.8
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in ferritin, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Ferritin
Week 2
|
11.6 % Change from baseline
Interval -11.2 to 35.9
|
8.8 % Change from baseline
Interval -0.2 to 25.3
|
8.8 % Change from baseline
Interval -7.4 to 31.0
|
|
Change in Markers of Iron Metabolism and Anemia - Ferritin
Week 4
|
19.1 % Change from baseline
Interval -6.8 to 32.9
|
8.3 % Change from baseline
Interval -3.5 to 38.8
|
13.6 % Change from baseline
Interval -3.8 to 35.3
|
|
Change in Markers of Iron Metabolism and Anemia - Ferritin
Week 8
|
4.0 % Change from baseline
Interval -24.1 to 15.9
|
30.4 % Change from baseline
Interval -5.6 to 38.7
|
16.7 % Change from baseline
Interval -10.1 to 32.5
|
|
Change in Markers of Iron Metabolism and Anemia - Ferritin
Week 12
|
-0.6 % Change from baseline
Interval -11.2 to 11.3
|
26.4 % Change from baseline
Interval 4.3 to 52.0
|
11.3 % Change from baseline
Interval -10.0 to 31.0
|
|
Change in Markers of Iron Metabolism and Anemia - Ferritin
Week 16
|
0.1 % Change from baseline
Interval -24.6 to 8.0
|
21.6 % Change from baseline
Interval 0.7 to 100.9
|
6.7 % Change from baseline
Interval -8.7 to 30.9
|
|
Change in Markers of Iron Metabolism and Anemia - Ferritin
Week 20
|
3.5 % Change from baseline
Interval -42.9 to 23.1
|
13.6 % Change from baseline
Interval -10.0 to 74.6
|
7.0 % Change from baseline
Interval -33.6 to 61.8
|
|
Change in Markers of Iron Metabolism and Anemia - Ferritin
Week 24
|
-14.2 % Change from baseline
Interval -40.2 to 6.6
|
15.4 % Change from baseline
Interval -20.7 to 59.7
|
1.4 % Change from baseline
Interval -27.2 to 42.6
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in soluble transferrin receptor, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Soluble Transferrin Receptor
Week 2
|
4.0 % Change from baseline
Interval -14.7 to 18.1
|
-4.9 % Change from baseline
Interval -12.8 to 6.3
|
-4.8 % Change from baseline
Interval -14.1 to 16.7
|
|
Change in Markers of Iron Metabolism and Anemia - Soluble Transferrin Receptor
Week 8
|
6.7 % Change from baseline
Interval -15.3 to 24.0
|
11.0 % Change from baseline
Interval -15.1 to 37.2
|
7.4 % Change from baseline
Interval -15.3 to 28.4
|
|
Change in Markers of Iron Metabolism and Anemia - Soluble Transferrin Receptor
Week 12
|
0.8 % Change from baseline
Interval -18.3 to 13.5
|
11.1 % Change from baseline
Interval 2.0 to 38.8
|
10.7 % Change from baseline
Interval -13.5 to 23.9
|
|
Change in Markers of Iron Metabolism and Anemia - Soluble Transferrin Receptor
Week 16
|
-0.1 % Change from baseline
Interval -17.3 to 19.2
|
14.9 % Change from baseline
Interval -9.1 to 32.3
|
1.3 % Change from baseline
Interval -9.1 to 27.3
|
|
Change in Markers of Iron Metabolism and Anemia - Soluble Transferrin Receptor
Week 4
|
-1.4 % Change from baseline
Interval -7.0 to 26.2
|
8.8 % Change from baseline
Interval -16.6 to 31.5
|
0.7 % Change from baseline
Interval -16.6 to 30.9
|
|
Change in Markers of Iron Metabolism and Anemia - Soluble Transferrin Receptor
Week 20
|
-1.8 % Change from baseline
Interval -11.2 to 10.6
|
-0.7 % Change from baseline
Interval -7.4 to 21.2
|
-1.2 % Change from baseline
Interval -11.2 to 14.1
|
|
Change in Markers of Iron Metabolism and Anemia - Soluble Transferrin Receptor
Week 24
|
-3.5 % Change from baseline
Interval -15.5 to 10.0
|
19.7 % Change from baseline
Interval -24.2 to 30.8
|
-1.8 % Change from baseline
Interval -16.7 to 26.1
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in transferrin saturation, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Transferrin Saturation
Week 2
|
2.4 % Change from baseline
Interval -15.2 to 52.1
|
13.5 % Change from baseline
Interval -6.7 to 35.6
|
10.3 % Change from baseline
Interval -8.3 to 44.1
|
|
Change in Markers of Iron Metabolism and Anemia - Transferrin Saturation
Week 4
|
36.4 % Change from baseline
Interval 4.2 to 75.0
|
9.7 % Change from baseline
Interval -17.2 to 36.7
|
10.5 % Change from baseline
Interval -4.8 to 45.8
|
|
Change in Markers of Iron Metabolism and Anemia - Transferrin Saturation
Week 8
|
9.5 % Change from baseline
Interval -21.7 to 33.3
|
-5.0 % Change from baseline
Interval -23.1 to 26.2
|
-3.1 % Change from baseline
Interval -22.4 to 29.7
|
|
Change in Markers of Iron Metabolism and Anemia - Transferrin Saturation
Week 12
|
11.9 % Change from baseline
Interval -18.6 to 52.9
|
16.4 % Change from baseline
Interval -3.8 to 26.3
|
14.1 % Change from baseline
Interval -18.3 to 26.7
|
|
Change in Markers of Iron Metabolism and Anemia - Transferrin Saturation
Week 16
|
-7.2 % Change from baseline
Interval -22.2 to 40.7
|
-13.5 % Change from baseline
Interval -24.6 to 33.3
|
-10.4 % Change from baseline
Interval -24.6 to 40.7
|
|
Change in Markers of Iron Metabolism and Anemia - Transferrin Saturation
Week 20
|
-2.5 % Change from baseline
Interval -20.7 to 36.4
|
-20.8 % Change from baseline
Interval -40.4 to 8.3
|
-13.3 % Change from baseline
Interval -31.9 to 9.3
|
|
Change in Markers of Iron Metabolism and Anemia - Transferrin Saturation
Week 24
|
-8.3 % Change from baseline
Interval -22.1 to 23.7
|
-20.8 % Change from baseline
Interval -31.7 to 25.0
|
-11.9 % Change from baseline
Interval -25.0 to 25.0
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in unsaturated iron binding capacity, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Unsaturated Iron Binding Capacity
Week 2
|
0.0 % Change from baseline
Interval -39.4 to 13.2
|
-5.1 % Change from baseline
Interval -31.1 to 14.6
|
0.0 % Change from baseline
Interval -31.5 to 13.2
|
|
Change in Markers of Iron Metabolism and Anemia - Unsaturated Iron Binding Capacity
Week 4
|
-4.0 % Change from baseline
Interval -24.3 to 1.9
|
0.0 % Change from baseline
Interval -35.7 to 34.0
|
-1.0 % Change from baseline
Interval -25.3 to 28.1
|
|
Change in Markers of Iron Metabolism and Anemia - Unsaturated Iron Binding Capacity
Week 12
|
2.9 % Change from baseline
Interval -17.4 to 31.4
|
-18.4 % Change from baseline
Interval -33.6 to 7.0
|
-1.6 % Change from baseline
Interval -32.3 to 21.4
|
|
Change in Markers of Iron Metabolism and Anemia - Unsaturated Iron Binding Capacity
Week 16
|
4.3 % Change from baseline
Interval -22.4 to 34.7
|
0.0 % Change from baseline
Interval -49.2 to 21.4
|
2.6 % Change from baseline
Interval -35.6 to 30.5
|
|
Change in Markers of Iron Metabolism and Anemia - Unsaturated Iron Binding Capacity
Week 8
|
6.4 % Change from baseline
Interval -25.0 to 28.0
|
0.0 % Change from baseline
Interval -40.2 to 31.8
|
0.0 % Change from baseline
Interval -29.9 to 28.4
|
|
Change in Markers of Iron Metabolism and Anemia - Unsaturated Iron Binding Capacity
Week 20
|
16.5 % Change from baseline
Interval -12.0 to 62.8
|
5.1 % Change from baseline
Interval -39.8 to 44.0
|
14.2 % Change from baseline
Interval -15.9 to 46.7
|
|
Change in Markers of Iron Metabolism and Anemia - Unsaturated Iron Binding Capacity
Week 24
|
12.0 % Change from baseline
Interval 2.5 to 32.2
|
6.9 % Change from baseline
Interval -35.7 to 64.9
|
12.0 % Change from baseline
Interval -11.3 to 64.9
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in platelets, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Platelets
Week 4
|
0.0 % Change from baseline
Interval -25.5 to 49.1
|
-29.7 % Change from baseline
Interval -43.7 to -4.1
|
-26.3 % Change from baseline
Interval -35.9 to 9.6
|
|
Change in Markers of Iron Metabolism and Anemia - Platelets
Week 8
|
19.7 % Change from baseline
Interval -1.3 to 57.2
|
-33.6 % Change from baseline
Interval -48.2 to 3.3
|
-12.0 % Change from baseline
Interval -40.3 to 23.0
|
|
Change in Markers of Iron Metabolism and Anemia - Platelets
Week 2
|
21.4 % Change from baseline
Interval -25.4 to 48.9
|
-24.4 % Change from baseline
Interval -41.8 to 6.3
|
-9.5 % Change from baseline
Interval -37.4 to 32.1
|
|
Change in Markers of Iron Metabolism and Anemia - Platelets
Week 12
|
24.1 % Change from baseline
Interval 7.9 to 83.7
|
-27.7 % Change from baseline
Interval -49.0 to -11.5
|
-11.4 % Change from baseline
Interval -39.9 to 27.3
|
|
Change in Markers of Iron Metabolism and Anemia - Platelets
Week 16
|
17.8 % Change from baseline
Interval 2.3 to 80.0
|
-26.1 % Change from baseline
Interval -48.0 to -6.2
|
-6.2 % Change from baseline
Interval -31.3 to 30.8
|
|
Change in Markers of Iron Metabolism and Anemia - Platelets
Week 20
|
31.0 % Change from baseline
Interval -6.9 to 41.4
|
-36.2 % Change from baseline
Interval -67.1 to -10.7
|
-14.3 % Change from baseline
Interval -37.8 to 34.3
|
|
Change in Markers of Iron Metabolism and Anemia - Platelets
Week 24
|
38.9 % Change from baseline
Interval -15.4 to 78.3
|
-22.5 % Change from baseline
Interval -52.1 to -8.8
|
-15.3 % Change from baseline
Interval -30.2 to 60.9
|
SECONDARY outcome
Timeframe: At Weeks 2, 4, 8, 12, 16, 20 and 24Percent change from baseline in leukocytes, where the baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Leukocytes
Week 8
|
34.3 % Change from baseline
Interval 11.6 to 57.1
|
-0.9 % Change from baseline
Interval -18.9 to 13.4
|
8.9 % Change from baseline
Interval -14.0 to 30.5
|
|
Change in Markers of Iron Metabolism and Anemia - Leukocytes
Week 2
|
11.6 % Change from baseline
Interval -10.0 to 42.9
|
-24.9 % Change from baseline
Interval -34.8 to 1.5
|
-14.9 % Change from baseline
Interval -29.8 to 11.4
|
|
Change in Markers of Iron Metabolism and Anemia - Leukocytes
Week 4
|
6.8 % Change from baseline
Interval -18.3 to 38.6
|
-4.7 % Change from baseline
Interval -26.4 to 11.4
|
0.7 % Change from baseline
Interval -21.1 to 19.8
|
|
Change in Markers of Iron Metabolism and Anemia - Leukocytes
Week 12
|
8.0 % Change from baseline
Interval 5.4 to 48.4
|
-15.4 % Change from baseline
Interval -35.5 to 22.9
|
5.4 % Change from baseline
Interval -24.2 to 38.7
|
|
Change in Markers of Iron Metabolism and Anemia - Leukocytes
Week 16
|
42.0 % Change from baseline
Interval 14.6 to 53.7
|
-6.7 % Change from baseline
Interval -26.9 to 27.0
|
15.2 % Change from baseline
Interval -14.3 to 45.7
|
|
Change in Markers of Iron Metabolism and Anemia - Leukocytes
Week 20
|
44.7 % Change from baseline
Interval 13.0 to 70.5
|
-27.5 % Change from baseline
Interval -42.1 to 24.8
|
16.3 % Change from baseline
Interval -32.8 to 49.1
|
|
Change in Markers of Iron Metabolism and Anemia - Leukocytes
Week 24
|
53.0 % Change from baseline
Interval 0.2 to 75.3
|
18.3 % Change from baseline
Interval -35.4 to 42.9
|
27.1 % Change from baseline
Interval -26.4 to 63.4
|
SECONDARY outcome
Timeframe: At Weeks 2 and 4Change from baseline in % blasts at Weeks 2 and 4. The baseline % blasts value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Markers of Iron Metabolism and Anemia - Blasts
Week 2
|
0 % Change from baseline
No blasts measured
|
3.0 % Change from baseline
Interval 3.0 to 3.0
|
3.0 % Change from baseline
Interval 3.0 to 3.0
|
|
Change in Markers of Iron Metabolism and Anemia - Blasts
Week 4
|
0 % Change from baseline
No blasts measured
|
1.0 % Change from baseline
Interval 1.0 to 1.0
|
1.0 % Change from baseline
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Measured at Week 24Percent change from baseline in liver iron content assessed by MRI. The baseline value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Liver Iron Content
|
4.7 % Change from baseline
Interval -18.4 to 25.0
|
53.3 % Change from baseline
Interval 20.6 to 86.2
|
22.3 % Change from baseline
Interval -6.0 to 71.7
|
SECONDARY outcome
Timeframe: On Day 1 and at Weeks 4 and 24Percent change in %pSTAT stimulated CD3+/4+ T cell at Day 1 (postdose), Week 4 and Week 24. The baseline value is defined as the last predose value from the baseline period prior to or on the date of first dose of momelotinib administration (Day 1 predose).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Week 24 - 2 hours postdose
|
-31.2 % Change from baseline
Interval -51.2 to -18.0
|
-10.7 % Change from baseline
Interval -28.4 to -10.1
|
-22.7 % Change from baseline
Interval -48.2 to -10.7
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Week 24 - 4 hours postdose
|
-30.6 % Change from baseline
Interval -65.8 to -17.6
|
-14.4 % Change from baseline
Interval -22.6 to -12.9
|
-22.6 % Change from baseline
Interval -50.1 to -14.1
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Week 24 - 6 hours postdose
|
-17.0 % Change from baseline
Interval -33.2 to -13.4
|
-10.1 % Change from baseline
Interval -10.2 to -4.9
|
-13.4 % Change from baseline
Interval -24.8 to -10.1
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Day 1 - 2 hours postdose
|
-15.8 % Change from baseline
Interval -34.2 to -11.6
|
-13.5 % Change from baseline
Interval -24.4 to -7.6
|
-14.3 % Change from baseline
Interval -27.7 to -9.6
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Day 1 - 4 hours postdose
|
-17.1 % Change from baseline
Interval -23.4 to -8.1
|
-10.6 % Change from baseline
Interval -30.6 to -2.4
|
-12.8 % Change from baseline
Interval -27.3 to -6.6
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Day 1 - 6 hours postdose
|
-9.0 % Change from baseline
Interval -16.9 to -4.0
|
-4.3 % Change from baseline
Interval -16.9 to 0.3
|
-7.1 % Change from baseline
Interval -16.9 to -2.2
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Week 4 - predose
|
-0.9 % Change from baseline
Interval -2.0 to 1.8
|
-2.9 % Change from baseline
Interval -5.5 to 17.7
|
-2.0 % Change from baseline
Interval -5.5 to 17.7
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Week 4 - 2 hours postdose
|
-18.9 % Change from baseline
Interval -21.9 to -6.6
|
-20.0 % Change from baseline
Interval -25.7 to -7.4
|
-20.0 % Change from baseline
Interval -25.7 to -6.6
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Week 4 - 4 hours postdose
|
-19.8 % Change from baseline
Interval -30.4 to -8.8
|
-14.1 % Change from baseline
Interval -28.7 to -6.1
|
-14.1 % Change from baseline
Interval -30.4 to -6.1
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Week 4 - 6 hours postdose
|
-12.1 % Change from baseline
Interval -29.0 to -1.5
|
-9.1 % Change from baseline
Interval -12.9 to 4.9
|
-9.1 % Change from baseline
Interval -19.0 to 4.9
|
|
Change in Pharmacodynamics Biomarker - pSTAT3
Week 24 - predose
|
-4.6 % Change from baseline
Interval -22.9 to 0.1
|
-0.3 % Change from baseline
Interval -7.9 to 5.1
|
-2.8 % Change from baseline
Interval -22.9 to 5.1
|
SECONDARY outcome
Timeframe: On Day 1 and at Weeks 4 and 24Percent change in %pSTAT/%tSTAT Stimulated CD3+/4+ T cell ratio at Day 1 (postdose), Week 4 and Week 24. The baseline value is defined as the last predose value from the baseline period prior to or on the date of first dose of momelotinib administration (Day 1 predose).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Day 1 - 2 hours postdose
|
-13.2 % Change from baseline
Interval -38.9 to -11.5
|
-15.5 % Change from baseline
Interval -23.2 to 2.5
|
-13.4 % Change from baseline
Interval -26.3 to -3.2
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Day 1 - 4 hours postdose
|
-9.6 % Change from baseline
Interval -23.2 to -0.5
|
-9.7 % Change from baseline
Interval -28.0 to -2.3
|
-9.7 % Change from baseline
Interval -23.9 to -2.3
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Week 4 - 4 hours postdose
|
3.0 % Change from baseline
Interval -32.9 to 118.3
|
-13.4 % Change from baseline
Interval -23.7 to 23.9
|
-13.4 % Change from baseline
Interval -31.5 to 38.1
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Week 4 - 6 hours postdose
|
12.5 % Change from baseline
Interval -29.4 to 56.0
|
-6.1 % Change from baseline
Interval -17.1 to 32.8
|
-6.1 % Change from baseline
Interval -20.5 to 56.0
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Week 24 - predose
|
-5.7 % Change from baseline
Interval -17.4 to -3.7
|
-3.5 % Change from baseline
Interval -8.8 to -2.8
|
-4.4 % Change from baseline
Interval -17.4 to -2.8
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Week 24 - 4 hours postdose
|
-21.4 % Change from baseline
Interval -27.1 to -14.3
|
-11.5 % Change from baseline
Interval -15.4 to -9.6
|
-15.4 % Change from baseline
Interval -27.0 to -11.5
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Week 24 - 6 hours postdose
|
-18.4 % Change from baseline
Interval -22.8 to -11.1
|
-6.5 % Change from baseline
Interval -9.0 to -5.1
|
-11.1 % Change from baseline
Interval -20.0 to -5.1
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Day 1 - 6 hours postdose
|
-9.1 % Change from baseline
Interval -17.2 to -5.7
|
-3.7 % Change from baseline
Interval -12.1 to 3.7
|
-4.6 % Change from baseline
Interval -13.7 to 1.7
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Week 4 - predose
|
0.5 % Change from baseline
Interval -5.2 to 31.8
|
5.0 % Change from baseline
Interval -4.3 to 39.8
|
4.8 % Change from baseline
Interval -5.2 to 39.8
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Week 4 - 2 hours postdose
|
-14.3 % Change from baseline
Interval -17.5 to 20.3
|
-9.1 % Change from baseline
Interval -22.6 to 9.6
|
-13.2 % Change from baseline
Interval -22.6 to 20.3
|
|
Change in Pharmacodynamics Biomarker - pSTAT3/tSTAT3 Ratio
Week 24 - 2 hours postdose
|
-18.7 % Change from baseline
Interval -22.3 to -15.4
|
-7.6 % Change from baseline
Interval -22.1 to -2.6
|
-16.2 % Change from baseline
Interval -22.3 to -2.6
|
SECONDARY outcome
Timeframe: At Weeks 2, 12 and 24Percent change in C-reactive protein at Weeks 2, 12 and 24. The baseline C-reactive protein value is defined as the last value from the baseline period prior to or on the date of first dose of momelotinib administration (Baseline visit).
Outcome measures
| Measure |
Total
n=14 Participants
All enrolled subjects
|
Transfusion Independence Non-Responders
n=27 Participants
Subjects who did not become transfusion independent by Week 24
|
Total
n=41 Participants
All enrolled subjects
|
|---|---|---|---|
|
Change in Inflammatory Markers - C-Reactive Protein (CRP)
Week 2
|
-68.7 % Change from baseline
Interval -75.6 to -43.5
|
-53.7 % Change from baseline
Interval -76.8 to -18.5
|
-55.6 % Change from baseline
Interval -76.3 to -29.5
|
|
Change in Inflammatory Markers - C-Reactive Protein (CRP)
Week 12
|
-67.8 % Change from baseline
Interval -73.1 to -28.2
|
-43.4 % Change from baseline
Interval -59.6 to 22.6
|
-48.9 % Change from baseline
Interval -70.1 to -15.6
|
|
Change in Inflammatory Markers - C-Reactive Protein (CRP)
Week 24
|
-59.8 % Change from baseline
Interval -79.1 to -44.8
|
-47.1 % Change from baseline
Interval -68.4 to 65.3
|
-54.8 % Change from baseline
Interval -73.8 to -30.7
|
Adverse Events
Momelotinib (MMB)
Serious events: 14 serious events
Other events: 36 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Momelotinib (MMB)
n=41 participants at risk
Subjects received oral MMB at a starting dose of 200 mg once daily for 24 weeks (± 7 days) on study.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Nervous system disorders
Presyncope
|
4.9%
2/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Nervous system disorders
Metabolic encephalopathy
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
General disorders
Asthenia
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
General disorders
Death
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
General disorders
Pyrexia
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Infections and infestations
Lung infection
|
4.9%
2/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Cardiac disorders
Cardiac arrest
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Vascular disorders
Hypotension
|
4.9%
2/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Investigations
Hepatic enzyme increased
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
1/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
Other adverse events
| Measure |
Momelotinib (MMB)
n=41 participants at risk
Subjects received oral MMB at a starting dose of 200 mg once daily for 24 weeks (± 7 days) on study.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
24.4%
10/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Gastrointestinal disorders
Nausea
|
22.0%
9/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
7/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.6%
6/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Gastrointestinal disorders
Constipation
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.3%
12/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
5/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Nervous system disorders
Dizziness
|
14.6%
6/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Nervous system disorders
Headache
|
14.6%
6/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.1%
7/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.2%
5/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
General disorders
Fatigue
|
19.5%
8/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
General disorders
Chills
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Infections and infestations
Urinary tract infection
|
14.6%
6/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.1%
7/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Investigations
Blood creatinine increased
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.8%
4/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.8%
4/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.2%
5/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Injury, poisoning and procedural complications
Fall
|
9.8%
4/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Renal and urinary disorders
Pollakiuria
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
|
Vascular disorders
Hypotension
|
7.3%
3/41 • From the first dose of momelotinib until 30 days following the last dose.
All adverse events summarized were treatment-emergent, defined as any adverse event with an onset date on or after the momelotinib start date and no later than 30 days after permanent discontinuation of momelotinib or any adverse event leading to premature discontinuation of momelotinib.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Most restrictive: Site may not present or publish results of Trial without advance written notice of Sponsor or two years after completion of Trial at all participating sites. Site must submit all proposed publications or presentations to Sponsor for review. Sponsor can review communications prior to public release and embargo trial results communications for a period between 75 and 180 days from submission to Sponsor for review. Sponsor has right to request Site remove Confidential Information.
- Publication restrictions are in place
Restriction type: OTHER