Trial Outcomes & Findings for Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer (NCT NCT01522443)
NCT ID: NCT01522443
Last Updated: 2018-05-23
Results Overview
The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
119 participants
Primary outcome timeframe
Pain response was measured at Week 6 and Week 12 by self-reports of subjects
Results posted on
2018-05-23
Participant Flow
First patient enrolled: 15 March 2012, Data cut off date: 06 October 2014. The study was terminated by the Sponsor after 119 subjects were enrolled which was less than the planned sample size of 246 subjects.
Participant milestones
| Measure |
Cabozantinib
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Mitoxantrone/Prednisone
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
Mitoxantrone (12mg/m\^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
58
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
53
|
55
|
Reasons for withdrawal
| Measure |
Cabozantinib
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Mitoxantrone/Prednisone
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
Mitoxantrone (12mg/m\^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
|---|---|---|
|
Overall Study
No longer receiving clinical benefit
|
36
|
28
|
|
Overall Study
Adverse Event
|
10
|
15
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
No study treatment given
|
1
|
1
|
|
Overall Study
Other
|
1
|
3
|
Baseline Characteristics
Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Cabozantinib
n=61 Participants
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Mitoxantrone/Prednisone
n=58 Participants
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
Mitoxantrone (12mg/m\^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Age, Customized
65 to <75 years
|
30 participants
n=5 Participants
|
26 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Age, Customized
75 to <85 years
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Geographic Region
North America
|
44 participants
n=5 Participants
|
36 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Geographic Region
Europe
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Geographic Region
Asia
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
ECOG Performance Status (per IVRS/IWRS)
0-1 (normal to symptoms, but ambulatory)
|
53 participants
n=5 Participants
|
52 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
ECOG Performance Status (per IVRS/IWRS)
≥2 (ambulatory to incapable of self-care/death)
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Randomization Stratification Factors (per IVRS/IWRS)
ECOG = 0-1 and prior cabazitaxel: yes
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Randomization Stratification Factors (per IVRS/IWRS)
ECOG = 0-1 and prior cabazitaxel: no
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Randomization Stratification Factors (per IVRS/IWRS)
ECOG ≥ 2 and prior cabazitaxel: yes
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Randomization Stratification Factors (per IVRS/IWRS)
ECOG ≥ 2 and prior cabazitaxel: no
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Time from initial diagnosis to randomization
|
4.7 years
n=5 Participants
|
5.3 years
n=7 Participants
|
5.0 years
n=5 Participants
|
|
Gleason score at diagnosis (Primary + Secondary)
<7
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Gleason score at diagnosis (Primary + Secondary)
7
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Gleason score at diagnosis (Primary + Secondary)
>7
|
40 participants
n=5 Participants
|
28 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Gleason score at diagnosis (Primary + Secondary)
Unknown
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Gleason score at diagnosis (Primary + Secondary)
Missing
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Prior prostate surgery/procedure
Transurethral resection of the prostate (TURP)
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Prior prostate surgery/procedure
Radical prostatectomy - with
|
17 participants
n=5 Participants
|
13 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Prior prostate surgery/procedure
Radical prostatectomy - without
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Prior prostate surgery/procedure
Cyrosurgery
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Prior prostate surgery/procedure
Bilateral orchiectomy
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Prior prostate surgery/procedure
Other
|
55 participants
n=5 Participants
|
52 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Bone-scan lesion area (BSLA)
|
72865.0 mm^2
n=5 Participants
|
72702.5 mm^2
n=7 Participants
|
72865.0 mm^2
n=5 Participants
|
|
Sites of prostate cancer metastasis
Bone
|
61 participants
n=5 Participants
|
58 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Sites of prostate cancer metastasis
Lymph node
|
29 participants
n=5 Participants
|
18 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Sites of prostate cancer metastasis
Visceral (soft tissue; liver)
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Sites of prostate cancer metastasis
Visceral (soft tissue; lung)
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Sites of prostate cancer metastasis
Other soft tissue
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Pain score (BPI Item 3) during Run-In Stage
|
6.00 units on a scale
n=5 Participants
|
6.14 units on a scale
n=7 Participants
|
6.00 units on a scale
n=5 Participants
|
|
Pain score (BPI Item 3) during Run-In Stage
4-5
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Pain score (BPI Item 3) during Run-In Stage
>5-6
|
22 participants
n=5 Participants
|
13 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Pain score (BPI Item 3) during Run-In Stage
>6-7
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Pain score (BPI Item 3) during Run-In Stage
>7-8
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Number of prior anticancer agents
2
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Number of prior anticancer agents
3
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Number of prior anticancer agents
4
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Number of prior anticancer agents
≥5
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Prior cabazitaxel (per IVRS/IWRS)
Yes
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Prior cabazitaxel (per IVRS/IWRS)
No
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pain response was measured at Week 6 and Week 12 by self-reports of subjectsPopulation: The primary analysis of pain response was based on the Intent to Treat (ITT) population of 119 participants (61 cabozantinib, 58 mitoxantrone plus prednisone).
The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline.
Outcome measures
| Measure |
Cabozantinib
n=61 Participants
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Mitoxantrone/Prednisone
n=58 Participants
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
Mitoxantrone (12mg/m\^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
|---|---|---|
|
Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported
|
15 percentage of responders
Interval 5.9 to 24.0
|
17 percentage of responders
Interval 7.5 to 27.0
|
SECONDARY outcome
Timeframe: BSR was measured at the end of Week 12 as determined by the IRFPopulation: Analysis was conducted on the randomized ITT population (61 cabozantinib, 58 mitoxantrone plus prednisone) for BSR at Week 12.
BSR is defined as \>=30% in the bone scan lesion area (BSLA) compared with baseline. Bones scans were evaluated by an independent radiology facility (IRF) for response.
Outcome measures
| Measure |
Cabozantinib
n=61 Participants
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Mitoxantrone/Prednisone
n=58 Participants
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
Mitoxantrone (12mg/m\^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
|---|---|---|
|
Bone Scan Response (BSR)
|
31 percentage of responders
Interval 20.0 to 43.0
|
5.2 percentage of responders
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: OS was measured at the time of randomization until 78 deathsPopulation: The Intent to Treat (ITT) population was used and included 119 randomized subjects (61 cabozantinib, 58 mitoxantrone plus prednisone) at the time of primary analysis (data cut off date: 06 October 2014).
OS was defined as the time from randomization to the date of death (due to any cause). Participants that had not died were censored at last known date alive. The analyses for OS occurred after 78/196 deaths (40% of the total required for the pre-specified primary analysis of OS). The data cut-off date was 06 October 2014. Median OS was calculated using Kaplan-Meier estimates.
Outcome measures
| Measure |
Cabozantinib
n=61 Participants
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Mitoxantrone/Prednisone
n=58 Participants
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
Mitoxantrone (12mg/m\^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
|---|---|---|
|
Overall Survival (OS)
|
9.0 months
Interval 6.8 to 11.56
|
7.9 months
Interval 5.26 to 9.1
|
Adverse Events
Cabozantinib
Serious events: 16 serious events
Other events: 60 other events
Deaths: 0 deaths
Mitoxantrone/Prednisone
Serious events: 15 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cabozantinib
n=60 participants at risk
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Mitoxantrone/Prednisone
n=57 participants at risk
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
Mitoxantrone (12mg/m\^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
|---|---|---|
|
Nervous system disorders
Hypoaesthesia
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Psychiatric disorders
Confusional state
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
2/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
3.5%
2/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
7.0%
4/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
5.3%
3/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
3.5%
2/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Nausea
|
3.3%
2/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
General disorders
Asthenia
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
General disorders
Malaise
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
General disorders
Pyrexia
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Infections and infestations
Pneumonia
|
3.3%
2/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Hepatic enzyme increased
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Liver function test abnormal
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Platelet count decreased
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Nervous system disorders
Depressed level of consciousness
|
1.7%
1/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
Other adverse events
| Measure |
Cabozantinib
n=60 participants at risk
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
Mitoxantrone/Prednisone
n=57 participants at risk
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
Mitoxantrone (12mg/m\^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
63.3%
38/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
42.1%
24/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
General disorders
Fatigue
|
56.7%
34/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
47.4%
27/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
46.7%
28/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
40.4%
23/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Diarrhoea
|
45.0%
27/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
29.8%
17/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Weight decreased
|
41.7%
25/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
14.0%
8/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Constipation
|
40.0%
24/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
33.3%
19/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Vomiting
|
38.3%
23/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
33.3%
19/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Vascular disorders
Hypertension
|
30.0%
18/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
General disorders
Asthenia
|
23.3%
14/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
7.0%
4/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Psychiatric disorders
Depression
|
23.3%
14/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
14.0%
8/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.7%
13/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
7.0%
4/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
12/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
3.5%
2/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
10/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
16.7%
10/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.0%
9/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
5.3%
3/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Dyspepsia
|
15.0%
9/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
7.0%
4/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Psychiatric disorders
Insomnia
|
15.0%
9/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
8.8%
5/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
15.0%
9/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Blood alkaline phosphatase increased
|
13.3%
8/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
3.5%
2/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.3%
8/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
8/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Oral pain
|
11.7%
7/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
6/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
3.5%
2/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
6/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
1.8%
1/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Neutrophil count decreased
|
10.0%
6/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
3.5%
2/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.0%
6/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Glossodynia
|
6.7%
4/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Lymphocyte count decreased
|
6.7%
4/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
4/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Investigations
Blood bilirubin increased
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Psychiatric disorders
Depressed mood
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Metabolism and nutrition disorders
Musculoskeletal stiffness
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Vascular disorders
Pallor
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Gastrointestinal disorders
Retching
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
General disorders
Sinusitis
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
3/60 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
0.00%
0/57 • Up to 95 weeks
The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreements with investigators vary; constant is our right to review results communications prior to public release, and embargo communications for a period of ≤60 days from submittal for review. We do not prohibit investigators from publishing, but we may require previously undisclosed confidential information, other than study results, to be removed from publications, and single-center publications are postponed until after publication of the trial's primary multicenter publication.
- Publication restrictions are in place
Restriction type: OTHER