Trial Outcomes & Findings for Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer (NCT NCT01625234)
NCT ID: NCT01625234
Last Updated: 2026-04-30
Results Overview
To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
131 participants
Primary outcome timeframe
28 Days
Results posted on
2026-04-30
Participant Flow
A total of 131 subjects were treated at 16 sites in the US, including 37 subjects in the escalation cohorts and 94 subjects in the expansion cohort.
Participant milestones
| Measure |
Phase I: X-396 (Ensartinib) at 25 mg
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 50 mg
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 100 mg
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg
Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 225 mg
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250 mg
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg
Dose expansion starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase II: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
5
|
11
|
4
|
10
|
94
|
|
Overall Study
COMPLETED
|
4
|
3
|
5
|
11
|
4
|
10
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase I: X-396 (Ensartinib) 200 mg
n=11 Participants
Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) 225 mg
n=4 Participants
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) 250 mg
n=10 Participants
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) 225 mg
n=94 Participants
Dose exxpansion at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase II: X-396 (ensartinib): Oral, ALK inhibitor
|
Total
n=131 Participants
Total of all reporting groups
|
Phase I: X-396 (Ensartinib) 25 mg
n=4 Participants
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) 50 mg
n=3 Participants
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) 100 mg
n=5 Participants
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
6 Participants
n=140 Participants
|
2 Participants
n=451 Participants
|
4 Participants
n=27 Participants
|
48 Participants
n=162 Participants
|
67 Participants
n=19729 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=162 Participants
|
2 Participants
n=19729 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=140 Participants
|
4 Participants
n=451 Participants
|
10 Participants
n=27 Participants
|
94 Participants
n=162 Participants
|
131 Participants
n=19729 Participants
|
4 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
5 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Continuous
|
57.5 Years
STANDARD_DEVIATION 14.05 • n=140 Participants
|
60.0 Years
STANDARD_DEVIATION 12.25 • n=451 Participants
|
55.4 Years
STANDARD_DEVIATION 11.58 • n=27 Participants
|
56.0 Years
STANDARD_DEVIATION 13.59 • n=162 Participants
|
56.2 Years
STANDARD_DEVIATION 12.92 • n=19729 Participants
|
53.5 Years
STANDARD_DEVIATION 7.33 • n=14 Participants
|
57.7 Years
STANDARD_DEVIATION 16.20 • n=34 Participants
|
56.2 Years
STANDARD_DEVIATION 4.87 • n=69 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=140 Participants
|
2 Participants
n=451 Participants
|
6 Participants
n=27 Participants
|
46 Participants
n=162 Participants
|
64 Participants
n=19729 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
18 Participants
n=162 Participants
|
19 Participants
n=19729 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=162 Participants
|
7 Participants
n=19729 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=140 Participants
|
4 Participants
n=451 Participants
|
10 Participants
n=27 Participants
|
65 Participants
n=162 Participants
|
98 Participants
n=19729 Participants
|
3 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=162 Participants
|
1 Participants
n=19729 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=162 Participants
|
4 Participants
n=19729 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=140 Participants
|
4 participants
n=451 Participants
|
10 participants
n=27 Participants
|
94 participants
n=162 Participants
|
131 participants
n=19729 Participants
|
4 participants
n=14 Participants
|
3 participants
n=34 Participants
|
5 participants
n=69 Participants
|
|
ECOG Performance Status
0
|
6 # of patients with Score Grade (0-5)
n=140 Participants
|
2 # of patients with Score Grade (0-5)
n=451 Participants
|
4 # of patients with Score Grade (0-5)
n=27 Participants
|
29 # of patients with Score Grade (0-5)
n=162 Participants
|
45 # of patients with Score Grade (0-5)
n=19729 Participants
|
1 # of patients with Score Grade (0-5)
n=14 Participants
|
0 # of patients with Score Grade (0-5)
n=34 Participants
|
3 # of patients with Score Grade (0-5)
n=69 Participants
|
|
ECOG Performance Status
1
|
5 # of patients with Score Grade (0-5)
n=140 Participants
|
2 # of patients with Score Grade (0-5)
n=451 Participants
|
6 # of patients with Score Grade (0-5)
n=27 Participants
|
63 # of patients with Score Grade (0-5)
n=162 Participants
|
84 # of patients with Score Grade (0-5)
n=19729 Participants
|
3 # of patients with Score Grade (0-5)
n=14 Participants
|
3 # of patients with Score Grade (0-5)
n=34 Participants
|
2 # of patients with Score Grade (0-5)
n=69 Participants
|
|
ECOG Performance Status
2
|
0 # of patients with Score Grade (0-5)
n=140 Participants
|
0 # of patients with Score Grade (0-5)
n=451 Participants
|
0 # of patients with Score Grade (0-5)
n=27 Participants
|
1 # of patients with Score Grade (0-5)
n=162 Participants
|
1 # of patients with Score Grade (0-5)
n=19729 Participants
|
0 # of patients with Score Grade (0-5)
n=14 Participants
|
0 # of patients with Score Grade (0-5)
n=34 Participants
|
0 # of patients with Score Grade (0-5)
n=69 Participants
|
|
ECOG Performance Status
Not Determined
|
0 # of patients with Score Grade (0-5)
n=140 Participants
|
0 # of patients with Score Grade (0-5)
n=451 Participants
|
0 # of patients with Score Grade (0-5)
n=27 Participants
|
1 # of patients with Score Grade (0-5)
n=162 Participants
|
1 # of patients with Score Grade (0-5)
n=19729 Participants
|
0 # of patients with Score Grade (0-5)
n=14 Participants
|
0 # of patients with Score Grade (0-5)
n=34 Participants
|
0 # of patients with Score Grade (0-5)
n=69 Participants
|
|
Tobacco user
Never
|
5 Participants
n=140 Participants
|
3 Participants
n=451 Participants
|
8 Participants
n=27 Participants
|
57 Participants
n=162 Participants
|
78 Participants
n=19729 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
|
Tobacco user
Former
|
5 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
2 Participants
n=27 Participants
|
36 Participants
n=162 Participants
|
49 Participants
n=19729 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Tobacco user
Current
|
1 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=162 Participants
|
4 Participants
n=19729 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: 28 DaysPopulation: Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1. For Phase study, patients must have NSCLC with ALK genomic alterations.
To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent.
Outcome measures
| Measure |
Phase I: X-396 (Ensartinib) at 100 mg
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250mg
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 225mg
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fed)
RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 200 mg (Fed)
Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 25mg
n=131 Participants
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 50 mg
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose
|
—
|
—
|
—
|
—
|
—
|
—
|
250 mg
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: The Tumor response evaluation population (Recommended Phase 2 Dose only) consisted of subjects who were ALK+ at 225 mg QD, completed at least 1 cycle of treatment, and had a post-baseline response assessment.
To explore the preliminary clinical tumor response after treatment with X-396 (ensartinib) given as a single agent in ALK positive patients at 225 mg QD. Subjects were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria (and CNS lesions were also assessed by modified Response Assessment in Neuro-Oncology). Assessments by CT or MRI were performed after every even cycle of treatment. All assessments were to be performed within 7 days of the scheduled day of assessment. Tumor lesions followed on physical examination must have been assessed on Day 1 of each cycle and at the End-of-Study Treatment Visit.
Outcome measures
| Measure |
Phase I: X-396 (Ensartinib) at 100 mg
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250mg
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 225mg
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fed)
RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 200 mg (Fed)
Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 25mg
n=81 Participants
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 50 mg
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Preliminary Tumor Response in ALK Positive Patients at 225 mg QD
|
—
|
—
|
—
|
—
|
—
|
—
|
34 participants
Interval 31.1 to 53.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.For Phase II of the study, patients must have NSCLC with ALK genomic alterations.
To characterize the preliminary pharmacokinetics including Cmax f X-396 given as a single agent
Outcome measures
| Measure |
Phase I: X-396 (Ensartinib) at 100 mg
n=5 Participants
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
n=8 Participants
Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250mg
n=10 Participants
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 225mg
n=3 Participants
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fed)
n=17 Participants
RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 200 mg (Fed)
n=3 Participants
Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 25mg
n=4 Participants
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
n=18 Participants
RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 50 mg
n=3 Participants
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentrations Cmax for Day 1
|
53 ng/ml
Standard Deviation 57.7
|
114 ng/ml
Standard Deviation 79.8
|
182 ng/ml
Standard Deviation 44.4
|
94 ng/ml
Standard Deviation 44.0
|
125 ng/ml
Standard Deviation 52.7
|
109 ng/ml
Standard Deviation 44.5
|
5 ng/ml
Standard Deviation 81.9
|
136 ng/ml
Standard Deviation 40.0
|
29 ng/ml
Standard Deviation 86.5
|
SECONDARY outcome
Timeframe: 24 hoursTo characterize the preliminary pharmacokinetics including T max of X-396 given as a single agent
Outcome measures
| Measure |
Phase I: X-396 (Ensartinib) at 100 mg
n=5 Participants
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
n=8 Participants
Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250mg
n=10 Participants
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 225mg
n=3 Participants
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fed)
n=17 Participants
RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 200 mg (Fed)
n=3 Participants
Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 25mg
n=4 Participants
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
n=18 Participants
RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 50 mg
n=3 Participants
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Tmax on Day 1
|
3.0 hour
Interval 2.98 to 8.2
|
3.5 hour
Interval 2.03 to 8.23
|
3.1 hour
Interval 1.0 to 7.17
|
6.0 hour
Interval 2.37 to 8.0
|
4.0 hour
Interval 1.03 to 24.0
|
4.0 hour
Interval 3.0 to 6.0
|
3.2 hour
Interval 2.25 to 6.0
|
3.2 hour
Interval 1.08 to 23.8
|
2.0 hour
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 0, 0.5h, 1.0h , 2.0 h, 4.0h, 6.0h, 8.0h, 24.0h,To characterize the preliminary pharmacokinetics including AUC of X-396 given as a single agent
Outcome measures
| Measure |
Phase I: X-396 (Ensartinib) at 100 mg
n=5 Participants
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
n=8 Participants
Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250mg
n=10 Participants
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 225mg
n=3 Participants
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fed)
n=17 Participants
RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 200 mg (Fed)
n=3 Participants
Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 25mg
n=4 Participants
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
n=18 Participants
RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 50 mg
n=3 Participants
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentrations AUC on Day 1
|
250 h·ng/mL
Standard Deviation 84.1
|
614 h·ng/mL
Standard Deviation 66.8
|
973 h·ng/mL
Standard Deviation 42.6
|
394 h·ng/mL
Standard Deviation 74.9
|
664 h·ng/mL
Standard Deviation 66.3
|
513 h·ng/mL
Standard Deviation 28.3
|
31 h·ng/mL
Standard Deviation 39.0
|
756 h·ng/mL
Standard Deviation 43.3
|
134 h·ng/mL
Standard Deviation 71.2
|
SECONDARY outcome
Timeframe: 24 hoursTo characterize the preliminary pharmacokinetics including half life of X-396 given as a single agent
Outcome measures
| Measure |
Phase I: X-396 (Ensartinib) at 100 mg
n=5 Participants
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg (Fasted)
n=8 Participants
Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250mg
n=10 Participants
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 225mg
n=3 Participants
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fed)
n=17 Participants
RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 200 mg (Fed)
n=3 Participants
Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle.
Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 25mg
n=4 Participants
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg (Fasted)
n=18 Participants
RP2D 225 mg (fasted) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations.
Phase II: X-396 (ensartinib): Expanded Cohort
|
Phase I: X-396 (Ensartinib) at 50 mg
n=3 Participants
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|---|---|
|
Plasma Concentrations Half-life on Day 1
|
12 hour
Standard Deviation 17.5
|
18 hour
Standard Deviation 20.1
|
23 hour
Standard Deviation 55.2
|
0 hour
Standard Deviation 0
|
14 hour
Standard Deviation 9.18
|
0 hour
Standard Deviation 0
|
0 hour
Standard Deviation 0
|
18 hour
Standard Deviation 52.1
|
0 hour
Standard Deviation 0
|
Adverse Events
Phase I: X-396 (Ensartinib) at 225 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I: X-396 (Ensartinib) at 250 mg
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase II: X-396 (Ensartinib) at 225 mg
Serious events: 41 serious events
Other events: 84 other events
Deaths: 3 deaths
Phase I: X-396 (Ensartinib) at 25 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: X-396 (Ensartinib) at 50 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: X-396 (Ensartinib) at 100 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase I: X-396 (Ensartinib) at 200 mg
Serious events: 6 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I: X-396 (Ensartinib) at 225 mg
n=4 participants at risk
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250 mg
n=10 participants at risk
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg
n=94 participants at risk
Dose expansion starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase II: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 25 mg
n=4 participants at risk
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 50 mg
n=3 participants at risk
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 100 mg
n=5 participants at risk
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg
n=11 participants at risk
Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
4.3%
4/94 • Number of events 4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
20.0%
1/5 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
18.2%
2/11 • Number of events 2 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Blood and lymphatic system disorders
Blood and lymphatic system
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
3.2%
3/94 • Number of events 3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
2.1%
2/94 • Number of events 2 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Cardiac disorders
Cardiac disorders
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
7.4%
7/94 • Number of events 7 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
3.2%
3/94 • Number of events 3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Cardiac disorders
Acute myocardial infraction
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
1.1%
1/94 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Cardiac disorders
Atrial fibrilation
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
2.1%
2/94 • Number of events 2 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
4.3%
4/94 • Number of events 4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
1.1%
1/94 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
18.2%
2/11 • Number of events 2 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
1.1%
1/94 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Metabolism and nutrition disorders
Metabolism and connective tissue disorders
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
3.2%
3/94 • Number of events 3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
27.3%
3/11 • Number of events 3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
3.2%
3/94 • Number of events 3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Musculoskeletal and connective tissue disorders
Muscoskeletal and connective tissue disorders
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
2.1%
2/94 • Number of events 2 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
9.1%
1/11 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
1.1%
1/94 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Nervous system disorders
Nervous system disorders
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
9.6%
9/94 • Number of events 9 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Nervous system disorders
Convulsion
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
3.2%
3/94 • Number of events 3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
2.1%
2/94 • Number of events 2 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
10.0%
1/10 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
12.8%
12/94 • Number of events 12 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
20.0%
1/5 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
27.3%
3/11 • Number of events 3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
Other adverse events
| Measure |
Phase I: X-396 (Ensartinib) at 225 mg
n=4 participants at risk
Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 250 mg
n=10 participants at risk
Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase II: X-396 (Ensartinib) at 225 mg
n=94 participants at risk
Dose expansion starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase II: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 25 mg
n=4 participants at risk
Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 50 mg
n=3 participants at risk
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 100 mg
n=5 participants at risk
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
Phase I: X-396 (Ensartinib) at 200 mg
n=11 participants at risk
Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
11.7%
11/94 • Number of events 11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
20.0%
1/5 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
8.5%
8/94 • Number of events 8 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
20.0%
1/5 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
50.0%
5/10 • Number of events 5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
60.6%
57/94 • Number of events 57 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
40.0%
2/5 • Number of events 2 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
54.5%
6/11 • Number of events 6 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
30.0%
3/10 • Number of events 3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
38.3%
36/94 • Number of events 36 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
20.0%
1/5 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
45.5%
5/11 • Number of events 5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
50.0%
5/10 • Number of events 5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
25.5%
24/94 • Number of events 24 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
33.3%
1/3 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
36.4%
4/11 • Number of events 4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
|
Investigations
Blood Creatinine increased
|
0.00%
0/4 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/10 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
9.6%
9/94 • Number of events 9 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
25.0%
1/4 • Number of events 1 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/3 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/5 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
0.00%
0/11 • From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
|
Additional Information
Vice President, Clinical Operations
Xcovery Holdings, Inc.
Phone: +1-561-835-9356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place