Trial Outcomes & Findings for Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19) (NCT NCT04668209)
NCT ID: NCT04668209
Last Updated: 2023-11-07
Results Overview
Adverse Events experienced by the patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Through Day 60
Results posted on
2023-11-07
Participant Flow
Participants were recruited from patients hospitalized with diagnosed/confirmed COVID-19 at two academic medical centers between January 2021 and April 2022. The first participant was enrolled on January 21st, 2021, and the last was enrolled in February 2022.
Of the 31 enrolled participants, 29 met inclusion criteria and were randomized.
Participant milestones
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Subject Expired
|
2
|
0
|
|
Overall Study
Withdrawn from study
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
Baseline characteristics by cohort
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 14.72 • n=99 Participants
|
43.9 years
STANDARD_DEVIATION 13.04 • n=107 Participants
|
46.4 years
STANDARD_DEVIATION 13.91 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
14 participants
n=107 Participants
|
29 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through Day 60Population: Intent to treat population (all participants assigned to Silmitasertib/Combo, or Standard of Care). The median treatment duration of Silmitasertib was 14 days. The treatment Durations (days) = the last administration date - the first administration.
Adverse Events experienced by the patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Experienced Incidence of Treatment Emergent Adverse Events
|
10 Participants
|
7 Participants
|
|
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Did not experience Incidence of Treatment Emergent Adverse Events
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Through Day 28Number of days from randomization to discharge, or to alleviation of cough (defined as mild or absent in a patient reported scale of 0=absent, 1=mild, 2=moderate, and 3=severe). Improvement must be sustained for at least 48 hours.
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
|
3 Days
Standard Deviation 1.5
|
3.4 Days
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Through hospital discharge, an average of 28 daysNumber of days from randomization to normalization of fever (defined as \<36.6°C from axillary site, or \< 37.2°C from oral site or \< 37.8°C from rectal or tympanic site), normalization of respiratory rate (\< 24 bpm while breathing room air), resolution of hypoxia (defined as SpO2 ≥ 93% in room air or P/F ≥ 300 mmHg). All these improvements must be sustained for at least 48 hours.
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
|
6 Days
Standard Deviation 4.1
|
5.1 Days
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Through Day 28Number of days from randomization to the first day on which the subject satisfies one of the following three categories from the ordinal NIAID 8- point Clinical Progression Outcomes scale collected daily from randomization through Day 28: Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Compare Time to Clinical Recovery in CX-4945 Treatment Group Evaluated From Randomization Through Day 28 as Compared to the Control Arm.
|
7.3 Days
Standard Deviation 4.6
|
6 Days
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Assessed on Day 14 and Day 28Difference in percentage of subjects with clinical recovery compared at Day 14 and Day 28.
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14
|
13 Participants
|
13 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Through Day 28Population: Missing data explains the discrepancy in the total analyzed.
Percentage of Participants at Each Clinical Status at Day 14 and Day 28 assessed by using the ordinal NIAID 8- point Clinical Progression Outcomes scale (Scale ranges from 1 (Death) to 8 (Not hospitalized, no limitations on activities)
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=11 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=9 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14 · Death
|
0 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14 · Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
|
1 Participants
|
2 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14 · Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
1 Participants
|
1 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14 · Hospitalized, requiring supplemental oxygen
|
2 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14 · Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
0 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14 · Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
0 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14 · Not hospitalized, limitation on activities and/or requiring home oxygen
|
5 Participants
|
2 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 14 · Not hospitalized, no limitations on activities
|
2 Participants
|
4 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28 · Death
|
2 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28 · Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
|
0 Participants
|
2 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28 · Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
0 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28 · Hospitalized, requiring supplemental oxygen
|
0 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28 · Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care
|
0 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28 · Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
|
0 Participants
|
0 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28 · Not hospitalized, limitation on activities and/or requiring home oxygen
|
4 Participants
|
1 Participants
|
|
To Compare Changes in Clinical Status of Patients Enrolled to CX-4945 Treatment Arm as Compared to the Control Arm at Day 14 and Day 28.
Day 28 · Not hospitalized, no limitations on activities
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Assessed at Day 1, Day 8, Day 14 and Day 28Population: Missing data explains the discrepancy in the total analyzed.
Difference in proportions of patients with conversion of positive RT-PCR to negative RT-PCR as assessed at Day 1, Day 8, Day 14 and Day 28.
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=12 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Day 1 · Positive
|
15 Participants
|
12 Participants
|
|
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Day 1 · Negative
|
0 Participants
|
0 Participants
|
|
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Day 8 · Positive
|
8 Participants
|
4 Participants
|
|
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Day 8 · Negative
|
3 Participants
|
2 Participants
|
|
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Day 14 · Positive
|
4 Participants
|
3 Participants
|
|
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Day 14 · Negative
|
5 Participants
|
2 Participants
|
|
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Day 28 · Positive
|
1 Participants
|
0 Participants
|
|
To Evaluate Preliminary Evidence of Anti-viral Activity of CX-4945 as Compared to the Control Arm.
Day 28 · Negative
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Through Day 14Population: No data collected for this outcome analysis.
Changes in chest imaging from Screening to Day 5 or 14
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through Day 28Days of hospitalization from randomization through Day 28
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=12 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=10 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Number of Days Hospitalized
|
10.1 Days
Standard Deviation 8.4
|
11.7 Days
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Assessed on Days 1, 4, 8, 11, and 14Population: Missing data explains the discrepancy in the total analyzed.
IL-6 level
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=13 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=11 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Evaluate Changes in IL-6 Level
Day 1 · Abnormal: High
|
5 Participants
|
6 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 1 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 1 · Normal
|
8 Participants
|
5 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 1 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 4 · Abnormal: High
|
4 Participants
|
4 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 4 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 4 · Normal
|
4 Participants
|
7 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 4 · Unable to determine
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 8 · Abnormal: High
|
5 Participants
|
3 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 8 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 8 · Normal
|
1 Participants
|
2 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 8 · Unable to determine
|
2 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 11 · Abnormal: High
|
7 Participants
|
5 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 11 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 11 · Normal
|
1 Participants
|
1 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 11 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 14 · Abnormal: High
|
6 Participants
|
5 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 14 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 14 · Normal
|
3 Participants
|
0 Participants
|
|
To Evaluate Changes in IL-6 Level
Day 14 · Unable to determine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed on Days 1, 4, 8, 11, and 14Population: Missing data explains the discrepancy in the total analyzed.
CRP level
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=13 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Evaluate Changes in CRP
Day 1 · Abnormal: High
|
12 Participants
|
13 Participants
|
|
To Evaluate Changes in CRP
Day 1 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 1 · Normal
|
3 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 1 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 4 · Abnormal: High
|
8 Participants
|
8 Participants
|
|
To Evaluate Changes in CRP
Day 4 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 4 · Normal
|
4 Participants
|
4 Participants
|
|
To Evaluate Changes in CRP
Day 4 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 8 · Abnormal: High
|
8 Participants
|
3 Participants
|
|
To Evaluate Changes in CRP
Day 8 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 8 · Normal
|
2 Participants
|
3 Participants
|
|
To Evaluate Changes in CRP
Day 8 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 11 · Abnormal: High
|
8 Participants
|
5 Participants
|
|
To Evaluate Changes in CRP
Day 11 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 11 · Normal
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 11 · Unable to determine
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 14 · Abnormal: High
|
6 Participants
|
4 Participants
|
|
To Evaluate Changes in CRP
Day 14 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CRP
Day 14 · Normal
|
2 Participants
|
1 Participants
|
|
To Evaluate Changes in CRP
Day 14 · Unable to determine
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed on Days 1, 4, 8, 11, and 14Population: Missing data explains the discrepancy in the total analyzed.
LDH level
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=14 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=13 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Evaluate Changes in LDH
Day1 · Abnormal: High
|
13 Participants
|
13 Participants
|
|
To Evaluate Changes in LDH
Day1 · Abnormal: Low
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day1 · Normal
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day1 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 4 · Abnormal: High
|
12 Participants
|
11 Participants
|
|
To Evaluate Changes in LDH
Day 4 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 4 · Normal
|
0 Participants
|
1 Participants
|
|
To Evaluate Changes in LDH
Day 4 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 8 · Abnormal: High
|
11 Participants
|
4 Participants
|
|
To Evaluate Changes in LDH
Day 8 · Abnormal: Low
|
0 Participants
|
1 Participants
|
|
To Evaluate Changes in LDH
Day 8 · Normal
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 8 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 11 · Abnormal: High
|
9 Participants
|
6 Participants
|
|
To Evaluate Changes in LDH
Day 11 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 11 · Normal
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 11 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 14 · Abnormal: High
|
8 Participants
|
2 Participants
|
|
To Evaluate Changes in LDH
Day 14 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in LDH
Day 14 · Normal
|
1 Participants
|
2 Participants
|
|
To Evaluate Changes in LDH
Day 14 · Unable to determine
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed on Days 1, 4, 8, 11, and 14Population: Missing data explains the discrepancy in the total analyzed.
CPK level
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=13 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=13 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Evaluate Changes in CPK
Day 1 · Abnormal: High
|
1 Participants
|
1 Participants
|
|
To Evaluate Changes in CPK
Day 1 · Abnormal: Low
|
4 Participants
|
2 Participants
|
|
To Evaluate Changes in CPK
Day 1 · Normal
|
8 Participants
|
10 Participants
|
|
To Evaluate Changes in CPK
Day 1 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CPK
Day 4 · Abnormal: High
|
2 Participants
|
0 Participants
|
|
To Evaluate Changes in CPK
Day 4 · Abnormal: Low
|
4 Participants
|
4 Participants
|
|
To Evaluate Changes in CPK
Day 4 · Normal
|
6 Participants
|
8 Participants
|
|
To Evaluate Changes in CPK
Day 4 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CPK
Day 8 · Abnormal: High
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in CPK
Day 8 · Abnormal: Low
|
6 Participants
|
1 Participants
|
|
To Evaluate Changes in CPK
Day 8 · Normal
|
3 Participants
|
5 Participants
|
|
To Evaluate Changes in CPK
Day 8 · Unable to determine
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in CPK
Day 11 · Abnormal: High
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in CPK
Day 11 · Abnormal: Low
|
2 Participants
|
3 Participants
|
|
To Evaluate Changes in CPK
Day 11 · Normal
|
7 Participants
|
4 Participants
|
|
To Evaluate Changes in CPK
Day 11 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in CPK
Day 14 · Abnormal: High
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in CPK
Day 14 · Abnormal: Low
|
1 Participants
|
2 Participants
|
|
To Evaluate Changes in CPK
Day 14 · Normal
|
8 Participants
|
3 Participants
|
|
To Evaluate Changes in CPK
Day 14 · Unable to determine
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed on Days 1, 4, 8, 11, and 14Population: Missing data explains the discrepancy in the total analyzed.
Ferritin level
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=14 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=13 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Evaluate Changes in Ferritin
Day 1 · Abnormal: High
|
13 Participants
|
8 Participants
|
|
To Evaluate Changes in Ferritin
Day 1 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in Ferritin
Day 1 · Normal
|
1 Participants
|
5 Participants
|
|
To Evaluate Changes in Ferritin
Day 1 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in Ferritin
Day 4 · Abnormal: High
|
11 Participants
|
7 Participants
|
|
To Evaluate Changes in Ferritin
Day 4 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in Ferritin
Day 4 · Normal
|
1 Participants
|
3 Participants
|
|
To Evaluate Changes in Ferritin
Day 4 · Unable to determine
|
0 Participants
|
1 Participants
|
|
To Evaluate Changes in Ferritin
Day 8 · Abnormal: High
|
9 Participants
|
4 Participants
|
|
To Evaluate Changes in Ferritin
Day 8 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in Ferritin
Day 8 · Normal
|
1 Participants
|
1 Participants
|
|
To Evaluate Changes in Ferritin
Day 8 · Unable to determine
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in Ferritin
Day 11 · Abnormal: High
|
8 Participants
|
5 Participants
|
|
To Evaluate Changes in Ferritin
Day 11 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in Ferritin
Day 11 · Normal
|
2 Participants
|
2 Participants
|
|
To Evaluate Changes in Ferritin
Day 11 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in Ferritin
Day 14 · Abnormal: High
|
6 Participants
|
3 Participants
|
|
To Evaluate Changes in Ferritin
Day 14 · Abnormal: Low
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in Ferritin
Day 14 · Normal
|
3 Participants
|
1 Participants
|
|
To Evaluate Changes in Ferritin
Day 14 · Unable to determine
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed on Days 1, 4, 8, 11, and 14Population: Missing data explains the discrepancy in the total analyzed.
D-dimer level
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=14 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=13 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
To Evaluate Changes in D-dimer
Day 1 · Abnormal: High
|
10 Participants
|
8 Participants
|
|
To Evaluate Changes in D-dimer
Day 1 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in D-dimer
Day 1 · Normal
|
2 Participants
|
3 Participants
|
|
To Evaluate Changes in D-dimer
Day 1 · Unable to determine
|
2 Participants
|
2 Participants
|
|
To Evaluate Changes in D-dimer
Day 4 · Abnormal: High
|
10 Participants
|
10 Participants
|
|
To Evaluate Changes in D-dimer
Day 4 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in D-dimer
Day 4 · Normal
|
2 Participants
|
2 Participants
|
|
To Evaluate Changes in D-dimer
Day 4 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in D-dimer
Day 8 · Abnormal: High
|
9 Participants
|
5 Participants
|
|
To Evaluate Changes in D-dimer
Day 8 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in D-dimer
Day 8 · Normal
|
1 Participants
|
1 Participants
|
|
To Evaluate Changes in D-dimer
Day 8 · Unable to determine
|
1 Participants
|
0 Participants
|
|
To Evaluate Changes in D-dimer
Day 11 · Abnormal: High
|
9 Participants
|
5 Participants
|
|
To Evaluate Changes in D-dimer
Day 11 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in D-dimer
Day 11 · Normal
|
1 Participants
|
1 Participants
|
|
To Evaluate Changes in D-dimer
Day 11 · Unable to determine
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in D-dimer
Day 14 · Abnormal: High
|
8 Participants
|
4 Participants
|
|
To Evaluate Changes in D-dimer
Day 14 · Abnormal: Low
|
0 Participants
|
0 Participants
|
|
To Evaluate Changes in D-dimer
Day 14 · Normal
|
0 Participants
|
1 Participants
|
|
To Evaluate Changes in D-dimer
Day 14 · Unable to determine
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 28Days of supplemental oxygen (if applicable) from randomization through day 28
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Number of Days of Supplemental Oxygen Use
|
4.8 Days
Standard Deviation 4.6
|
4.2 Days
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Through Day 60The number of deaths occurred in each treatment group from randomization through Day 60
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
All-cause Mortality Status
Death - Yes
|
2 Participants
|
2 Participants
|
|
All-cause Mortality Status
Death - No
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Through Day 28Days of non-invasive ventilation/high flow oxygen (if applicable) from randomization through day 28
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Number of Days of On-invasive Ventilation/High Flow Oxygen
|
2.1 Days
Standard Deviation 4.1
|
1.9 Days
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Through Day 28Days of invasive mechanical ventilation/ECMO (if applicable) from randomization through Day 28.
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Number of Days of Invasive Mechanical Ventilation/ECMO
|
1.9 Days
Standard Deviation 5.3
|
3 Days
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Through Day 28Number of patients returned to room air after randomization through Day 14 or Day 28.
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Number of Patients Returned to Room Air
Day 14 · Return to room air: Yes
|
12 Participants
|
10 Participants
|
|
Number of Patients Returned to Room Air
Day 14 · Return to room air: No
|
3 Participants
|
4 Participants
|
|
Number of Patients Returned to Room Air
Day 28 · Return to room air: Yes
|
12 Participants
|
10 Participants
|
|
Number of Patients Returned to Room Air
Day 28 · Return to room air: No
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 4, 8, 11, 14, and 28Population: Missing data explains the discrepancy in the total analyzed.
Change in pulse oxygen saturation (SpO2) from randomization to Day 4, 8, 11, 14 and 28
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=13 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=12 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Change in Pulse Oxygen Saturation
Day 4
|
0.5 percentage of hemoglobin saturation
Standard Deviation 3.4
|
-1.1 percentage of hemoglobin saturation
Standard Deviation 1.8
|
|
Change in Pulse Oxygen Saturation
Day 8
|
1.3 percentage of hemoglobin saturation
Standard Deviation 3.3
|
0.3 percentage of hemoglobin saturation
Standard Deviation 3.6
|
|
Change in Pulse Oxygen Saturation
Day 11
|
-0.4 percentage of hemoglobin saturation
Standard Deviation 4.8
|
-0.5 percentage of hemoglobin saturation
Standard Deviation 5.6
|
|
Change in Pulse Oxygen Saturation
Day 14
|
-0.5 percentage of hemoglobin saturation
Standard Deviation 3.9
|
-1.8 percentage of hemoglobin saturation
Standard Deviation 8.8
|
|
Change in Pulse Oxygen Saturation
Day 28
|
1.7 percentage of hemoglobin saturation
Standard Deviation 2.6
|
1.7 percentage of hemoglobin saturation
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Through Day 28Population: No data collected for this outcome analysis.
Number of documented venous thromboembolism (VTE), arterial thrombosis (stroke, myocardial infarction, other) and microthrombosis events from randomization through Day 28
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days randomization, 8, 14 and 28Population: Missing data explains the discrepancy in the total analyzed.
The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). Higher values indicate worse outcomes, while lower indicate better outcomes. The subscales are combined to compute a total score and averaged to produce the mean and SD. Changes in EQ-D5-5L (used as an indicator of symptom improvement) from randomization to Day 8, 14 and 28
Outcome measures
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=10 Participants
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=9 Participants
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Changes in EQ-D5-5L
Day 28 Self-care score
|
-1.3 score on a scale
Standard Deviation 1.7
|
-2.8 score on a scale
Standard Deviation 1.3
|
|
Changes in EQ-D5-5L
Day 8 Mobility score
|
-1 score on a scale
Standard Deviation 1.6
|
-1.7 score on a scale
Standard Deviation 1.2
|
|
Changes in EQ-D5-5L
Day 14 Mobility score
|
-1.1 score on a scale
Standard Deviation 1.6
|
-1.7 score on a scale
Standard Deviation 1.5
|
|
Changes in EQ-D5-5L
Day 28 Mobility score
|
-1.4 score on a scale
Standard Deviation 1.9
|
-2.6 score on a scale
Standard Deviation 1.1
|
|
Changes in EQ-D5-5L
Day 8 Self-care score
|
-1.2 score on a scale
Standard Deviation 1.6
|
-2.1 score on a scale
Standard Deviation 2.6
|
|
Changes in EQ-D5-5L
Day 14 Self-care score
|
-1.1 score on a scale
Standard Deviation 1.8
|
-3 score on a scale
Standard Deviation 1.7
|
|
Changes in EQ-D5-5L
Day 8 Usual activities score
|
-2.3 score on a scale
Standard Deviation 1.6
|
-0.7 score on a scale
Standard Deviation 2.2
|
|
Changes in EQ-D5-5L
Day 14 Usual activities score
|
-2.3 score on a scale
Standard Deviation 1.6
|
-1.4 score on a scale
Standard Deviation 1.4
|
|
Changes in EQ-D5-5L
Day 28 Usual activities score
|
-2.6 score on a scale
Standard Deviation 1.6
|
-1.4 score on a scale
Standard Deviation 1.3
|
|
Changes in EQ-D5-5L
Day 8 Pain/discomfort score
|
0.3 score on a scale
Standard Deviation 1.1
|
-0.8 score on a scale
Standard Deviation 1
|
|
Changes in EQ-D5-5L
Day 14 Pain/discomfort score
|
-0.2 score on a scale
Standard Deviation 0.4
|
-0.3 score on a scale
Standard Deviation 1.3
|
|
Changes in EQ-D5-5L
Day 28 Pain/discomfort score
|
-0.3 score on a scale
Standard Deviation 0.7
|
-0.2 score on a scale
Standard Deviation 1.3
|
|
Changes in EQ-D5-5L
Day 8 Anxiety/depression score
|
0 score on a scale
Standard Deviation 0.8
|
0.1 score on a scale
Standard Deviation 0.6
|
|
Changes in EQ-D5-5L
Day 14 Anxiety/depression score
|
-0.2 score on a scale
Standard Deviation 0.7
|
-0.1 score on a scale
Standard Deviation 1.2
|
|
Changes in EQ-D5-5L
Day 28 Anxiety/depression score
|
0 score on a scale
Standard Deviation 0.5
|
-0.2 score on a scale
Standard Deviation 1.1
|
Adverse Events
Silmitasertib (CX-4945) in Combination With Standard of Care
Serious events: 3 serious events
Other events: 10 other events
Deaths: 2 deaths
Standard of Care
Serious events: 2 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 participants at risk
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 participants at risk
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea worsened
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxemic respiratory failure
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Cardiac disorders
Premature atrial contractions
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
Other adverse events
| Measure |
Silmitasertib (CX-4945) in Combination With Standard of Care
n=15 participants at risk
Standard of care / supportive care in combination with Silmitasertib (CX-4945)
Participants received Silmitasertib (CX-4945) 1000 mg tablets orally twice a day for 14 days. Participants received supportive care/Standard of Care as assigned by the investigator.
|
Standard of Care
n=14 participants at risk
Standard of care / supportive care
Participants received supportive care/Standard of Care.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Cardiac disorders
Premature atrial contractions
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Gastrointestinal disorders
Bloody diarrhea
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
14.3%
2/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Gastrointestinal disorders
Diarrhea worsened
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Gastrointestinal disorders
Loose stools
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Gastrointestinal disorders
Melena
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
14.3%
2/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
General disorders
Weakness
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Infections and infestations
Pilonidal cyst worsened
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Investigations
Weight loss
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Metabolism and nutrition disorders
Decrease appetite
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Musculoskeletal and connective tissue disorders
Leg Pain Bilateral
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Psychiatric disorders
Depression worsened
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxemic respiratory failure
|
13.3%
2/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea worsened
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening hypoxia
|
0.00%
0/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
7.1%
1/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis anal
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
6.7%
1/15 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/14 • Day 60.
Adverse Events experienced by patients from randomization to Day 60 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place