Trial Outcomes & Findings for Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery (NCT NCT01835145)
NCT ID: NCT01835145
Last Updated: 2022-08-04
Results Overview
A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The success for each arm will be calculated independently as the number of successes divided by the total number of evaluable patients. A one-sided chi-squared test for a difference in PFS4 proportions will be used to test for a difference between arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
At 4 months
Results posted on
2022-08-04
Participant Flow
Participant milestones
| Measure |
Arm I (Cabozantinib-s-malate)
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide or Dacarbazine)
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
15
|
|
Overall Study
COMPLETED
|
31
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Cabozantinib-s-malate)
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide or Dacarbazine)
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Ineligible prior to treatment
|
1
|
0
|
Baseline Characteristics
Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm I (Cabozantinib-s-malate)
n=31 Participants
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide or Dacarbazine)
n=15 Participants
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \>\>
\>\> If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
67 years
n=7 Participants
|
62.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4 monthsPopulation: All patients that began protocol treatment were included in this analysis.
A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The success for each arm will be calculated independently as the number of successes divided by the total number of evaluable patients. A one-sided chi-squared test for a difference in PFS4 proportions will be used to test for a difference between arms.
Outcome measures
| Measure |
Arm I (Cabozantinib-s-malate)
n=31 Participants
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide or Dacarbazine)
n=15 Participants
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4)
|
.323 proportion of participants
Interval 0.167 to 0.514
|
.267 proportion of participants
Interval 0.078 to 0.551
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe confirmed response rates will be estimated by dividing the number of confirmed responders by the number of evaluable patients. 95% confidence intervals will be calculated.
Outcome measures
| Measure |
Arm I (Cabozantinib-s-malate)
n=31 Participants
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide or Dacarbazine)
n=15 Participants
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearspercentage of patients who experienced grade 3+ adverse events regardless of attribution, graded according to the National Cancer Institute CTCAE version 4.0
Outcome measures
| Measure |
Arm I (Cabozantinib-s-malate)
n=31 Participants
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide or Dacarbazine)
n=15 Participants
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percentage of Patients Who Experienced Grade 3+ Adverse Events Regardless of Attribution
|
51.6 percentage of patients
|
20 percentage of patients
|
SECONDARY outcome
Timeframe: Number of days from registration until death, assessed up to 2 yearsThe distribution of OS time will be estimated using the method of Kaplan Meier.
Outcome measures
| Measure |
Arm I (Cabozantinib-s-malate)
n=31 Participants
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide or Dacarbazine)
n=15 Participants
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
6.3 months
Interval 5.5 to 10.3
|
7.2 months
Interval 5.6 to
The 95% confidence interval upper limit was not estimated (insufficient number of participants with events).
|
SECONDARY outcome
Timeframe: Number of days from registration until disease progression (or death), assessed up to 2 yearsThe distribution of PFS time will be estimated using the method of Kaplan Meier and is defined as the number of days from registration until disease progression (or death). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Arm I (Cabozantinib-s-malate)
n=31 Participants
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide or Dacarbazine)
n=15 Participants
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
\>
\> If temozolomide is not available, patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
PFS
|
2.0 months
Interval 1.8 to 5.3
|
1.9 months
Interval 1.8 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Cabozantinib-s-malate)
Serious events: 15 serious events
Other events: 30 other events
Deaths: 2 deaths
Arm II (Temozolomide)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 1 deaths
Arm II (Dacarbazine)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Cabozantinib-s-malate)
n=31 participants at risk
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide)
n=11 participants at risk
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Dacarbazine)
n=4 participants at risk
Patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
General disorders
Death NOS
|
6.5%
2/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
General disorders
Fatigue
|
6.5%
2/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
6.5%
2/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Immune system disorders
Anaphylaxis
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/31
|
9.1%
1/11 • Number of events 2
|
0.00%
0/4
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Lung infection
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Investigations
Alanine aminotransferase increased
|
12.9%
4/31 • Number of events 5
|
0.00%
0/11
|
0.00%
0/4
|
|
Investigations
Alkaline phosphatase increased
|
6.5%
2/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Investigations
Aspartate aminotransferase increased
|
12.9%
4/31 • Number of events 5
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Investigations
Blood bilirubin increased
|
6.5%
2/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Investigations
Creatinine increased
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Investigations
Ejection fraction decreased
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Investigations
Lipase increased
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Investigations
Neutrophil count decreased
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Platelet count decreased
|
0.00%
0/31
|
0.00%
0/11
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
2/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Number of events 3
|
0.00%
0/11
|
0.00%
0/4
|
|
Vascular disorders
Thromboembolic event
|
12.9%
4/31 • Number of events 4
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Arm I (Cabozantinib-s-malate)
n=31 participants at risk
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Temozolomide)
n=11 participants at risk
Patients receive 150 mg/m\^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm II (Dacarbazine)
n=4 participants at risk
Patients receive 1000 mg/m\^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.5%
2/31 • Number of events 4
|
54.5%
6/11 • Number of events 9
|
0.00%
0/4
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Cardiac disorders
Palpitations
|
6.5%
2/31 • Number of events 3
|
0.00%
0/11
|
0.00%
0/4
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/31
|
9.1%
1/11 • Number of events 3
|
0.00%
0/4
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
1/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Endocrine disorders
Hyperthyroidism
|
6.5%
2/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Endocrine disorders
Hypothyroidism
|
9.7%
3/31 • Number of events 17
|
18.2%
2/11 • Number of events 6
|
0.00%
0/4
|
|
Eye disorders
Dry eye
|
0.00%
0/31
|
9.1%
1/11 • Number of events 5
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • Number of events 2
|
27.3%
3/11 • Number of events 6
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
9.7%
3/31 • Number of events 6
|
27.3%
3/11 • Number of events 6
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhea
|
48.4%
15/31 • Number of events 41
|
36.4%
4/11 • Number of events 6
|
50.0%
2/4 • Number of events 5
|
|
Gastrointestinal disorders
Dry mouth
|
12.9%
4/31 • Number of events 5
|
9.1%
1/11 • Number of events 3
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • Number of events 4
|
18.2%
2/11 • Number of events 3
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/31
|
18.2%
2/11 • Number of events 3
|
0.00%
0/4
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.2%
1/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/31
|
9.1%
1/11 • Number of events 4
|
0.00%
0/4
|
|
Gastrointestinal disorders
Mucositis oral
|
12.9%
4/31 • Number of events 5
|
0.00%
0/11
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
35.5%
11/31 • Number of events 20
|
54.5%
6/11 • Number of events 16
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
6.5%
2/31 • Number of events 2
|
9.1%
1/11 • Number of events 4
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
6/31 • Number of events 6
|
36.4%
4/11 • Number of events 6
|
25.0%
1/4 • Number of events 3
|
|
General disorders
Chills
|
0.00%
0/31
|
9.1%
1/11 • Number of events 3
|
25.0%
1/4 • Number of events 6
|
|
General disorders
Edema limbs
|
3.2%
1/31 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Fatigue
|
64.5%
20/31 • Number of events 51
|
90.9%
10/11 • Number of events 31
|
75.0%
3/4 • Number of events 5
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Pain
|
9.7%
3/31 • Number of events 5
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/31
|
9.1%
1/11 • Number of events 2
|
0.00%
0/4
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Investigations
Alanine aminotransferase increased
|
67.7%
21/31 • Number of events 71
|
54.5%
6/11 • Number of events 17
|
25.0%
1/4 • Number of events 3
|
|
Investigations
Alkaline phosphatase increased
|
16.1%
5/31 • Number of events 9
|
27.3%
3/11 • Number of events 6
|
0.00%
0/4
|
|
Investigations
Aspartate aminotransferase increased
|
83.9%
26/31 • Number of events 85
|
90.9%
10/11 • Number of events 26
|
50.0%
2/4 • Number of events 4
|
|
Investigations
Blood bilirubin increased
|
19.4%
6/31 • Number of events 10
|
27.3%
3/11 • Number of events 4
|
50.0%
2/4 • Number of events 3
|
|
Investigations
Creatinine increased
|
6.5%
2/31 • Number of events 4
|
9.1%
1/11 • Number of events 4
|
0.00%
0/4
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Hemoglobin increased
|
3.2%
1/31 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Investigations
Investigations - Other, specify
|
3.2%
1/31 • Number of events 3
|
18.2%
2/11 • Number of events 10
|
0.00%
0/4
|
|
Investigations
Lipase increased
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Investigations
Lymphocyte count decreased
|
6.5%
2/31 • Number of events 3
|
27.3%
3/11 • Number of events 7
|
0.00%
0/4
|
|
Investigations
Neutrophil count decreased
|
22.6%
7/31 • Number of events 13
|
18.2%
2/11 • Number of events 6
|
50.0%
2/4 • Number of events 5
|
|
Investigations
Platelet count decreased
|
38.7%
12/31 • Number of events 27
|
45.5%
5/11 • Number of events 9
|
50.0%
2/4 • Number of events 6
|
|
Investigations
Weight loss
|
19.4%
6/31 • Number of events 9
|
18.2%
2/11 • Number of events 9
|
0.00%
0/4
|
|
Investigations
White blood cell decreased
|
9.7%
3/31 • Number of events 5
|
36.4%
4/11 • Number of events 8
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Anorexia
|
22.6%
7/31 • Number of events 14
|
27.3%
3/11 • Number of events 10
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Dehydration
|
9.7%
3/31 • Number of events 3
|
0.00%
0/11
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.9%
4/31 • Number of events 6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.7%
3/31 • Number of events 3
|
36.4%
4/11 • Number of events 9
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
1/31 • Number of events 1
|
18.2%
2/11 • Number of events 4
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.7%
3/31 • Number of events 4
|
27.3%
3/11 • Number of events 5
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
3/31 • Number of events 4
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Number of events 2
|
18.2%
2/11 • Number of events 4
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.5%
2/31 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.2%
1/31 • Number of events 10
|
0.00%
0/11
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.2%
1/31 • Number of events 2
|
18.2%
2/11 • Number of events 4
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/31
|
9.1%
1/11 • Number of events 2
|
0.00%
0/4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • Number of events 6
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Dysgeusia
|
12.9%
4/31 • Number of events 11
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Number of events 4
|
9.1%
1/11 • Number of events 3
|
0.00%
0/4
|
|
Nervous system disorders
Hypersomnia
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Psychiatric disorders
Depression
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Number of events 1
|
9.1%
1/11 • Number of events 3
|
0.00%
0/4
|
|
Renal and urinary disorders
Hematuria
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Renal and urinary disorders
Proteinuria
|
19.4%
6/31 • Number of events 10
|
0.00%
0/11
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31
|
18.2%
2/11 • Number of events 2
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/31
|
18.2%
2/11 • Number of events 8
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • Number of events 1
|
0.00%
0/11
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.2%
1/31 • Number of events 1
|
18.2%
2/11 • Number of events 5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/31
|
9.1%
1/11 • Number of events 5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/31
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.5%
2/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.7%
3/31 • Number of events 9
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.2%
1/31 • Number of events 4
|
0.00%
0/11
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.5%
2/31 • Number of events 5
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Number of events 2
|
0.00%
0/11
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.2%
1/31 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
1/31 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.7%
3/31 • Number of events 4
|
9.1%
1/11 • Number of events 3
|
0.00%
0/4
|
|
Vascular disorders
Hot flashes
|
0.00%
0/31
|
9.1%
1/11 • Number of events 3
|
0.00%
0/4
|
|
Vascular disorders
Hypertension
|
58.1%
18/31 • Number of events 61
|
45.5%
5/11 • Number of events 17
|
25.0%
1/4 • Number of events 2
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/4
|
|
Vascular disorders
Thromboembolic event
|
3.2%
1/31 • Number of events 4
|
0.00%
0/11
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60