Trial Outcomes & Findings for Trial of Cabozantinib (XL184) in Castrate-Resistant Prostate Cancer Metastatic to Bone (NCT NCT01428219)
NCT ID: NCT01428219
Last Updated: 2017-12-12
Results Overview
Efficacy will be measured by the proportion of participants who remain progression-free at 12 weeks after initiation of the study. RECIST 1.1 will be used to measure progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Kaplan-Meier methods will be used to report progression-free survival.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
12 weeks after participant initiates study
Results posted on
2017-12-12
Participant Flow
Participant milestones
| Measure |
Cabozantinib (XL184)
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Cabozantinib (XL184)
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Overall Study
25 patients enrolled, 3 were not treated
|
3
|
Baseline Characteristics
Trial of Cabozantinib (XL184) in Castrate-Resistant Prostate Cancer Metastatic to Bone
Baseline characteristics by cohort
| Measure |
Cabozantinib (XL184)
n=25 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after participant initiates studyEfficacy will be measured by the proportion of participants who remain progression-free at 12 weeks after initiation of the study. RECIST 1.1 will be used to measure progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Kaplan-Meier methods will be used to report progression-free survival.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=22 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Percentage of Participants Who Remain Progression-free at 12 Weeks
|
77.3 Percentage of participants
Interval 54.6 to 92.2
|
SECONDARY outcome
Timeframe: 18 monthsThe incidence of grades 1-3 AEs, by CTCAE 4.0 category, either possibly, probably or definitely related to treatment. The NCI Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for AE reporting.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=22 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Incidence of Adverse Events (AEs) Related to Treatment
Blood and Lymphatic System
|
10 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Cardiac
|
2 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Ear and Labyrinth
|
2 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Endocrine
|
4 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Eye
|
1 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Gastrointestinal
|
68 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
General and Administrative Site Conditions
|
18 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Immune System
|
1 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Infections
|
7 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Injury
|
2 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Investigations
|
78 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Metabolism and Nutrition
|
29 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Musculoskeletal and Soft Tissue
|
8 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Nervous System
|
19 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Psychiatric
|
2 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Renal and Urinary
|
12 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Reproductive and Breast
|
1 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Respiratory, Thoracic and Mediastinal
|
17 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Skin and Subcutaneous
|
24 adverse events reported
|
|
Incidence of Adverse Events (AEs) Related to Treatment
Vascular
|
11 adverse events reported
|
SECONDARY outcome
Timeframe: 18 monthsMean fold change in markers of bone metabolism in bone and serum with cabozantinib. Bone biomarkers include Osteocalcin, NTx, TRAcP, BMP2, SOST, BAP, CICP
Outcome measures
| Measure |
Cabozantinib (XL184)
n=22 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib
Osteocalcin
|
-3.3 unitless
Standard Deviation 5.8
|
|
Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib
NTx
|
0.5 unitless
Standard Deviation 15.4
|
|
Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib
TRAcP
|
-0.1 unitless
Standard Deviation 2.4
|
|
Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib
BMP2
|
65.5 unitless
Standard Deviation 49.1
|
|
Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib
SOST
|
-29.8 unitless
Standard Deviation 94.5
|
|
Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib
BAP
|
-1.36 unitless
Standard Deviation 56.6
|
|
Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib
CICP
|
4.8 unitless
Standard Deviation 80.6
|
SECONDARY outcome
Timeframe: 12 weeksThe percentage of participants alive without progression at 12 weeks
Outcome measures
| Measure |
Cabozantinib (XL184)
n=22 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Progression-free Survival
|
89.5 percentage of participants
Interval 64.1 to 97.3
|
SECONDARY outcome
Timeframe: 18 monthsThe percentage of participants that respond in soft tissue and bone disease.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=22 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Response Proportion in Both Soft Tissue and Bone Disease.
Bone Disease
|
59 percentage of participants
|
|
Response Proportion in Both Soft Tissue and Bone Disease.
Soft Tissue
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsDuration of response in soft tissue and bone.
Outcome measures
| Measure |
Cabozantinib (XL184)
n=22 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Duration of Response.
Soft Tissue (only one responder)
|
9 weeks
Interval 9.0 to 9.0
|
|
Duration of Response.
Bone
|
18 weeks
Interval 6.0 to 80.0
|
SECONDARY outcome
Timeframe: 12 weeksThe number of patients that are progression free by PSA at 12 weeks
Outcome measures
| Measure |
Cabozantinib (XL184)
n=22 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
The Number of Patients That Are Progression Free by PSA
|
8 Participants
|
SECONDARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Cabozantinib (XL184)
n=22 Participants
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Median Time to PSA Progression
|
6 weeks
Interval 6.0 to 84.0
|
Adverse Events
Cabozantinib (XL184)
Serious events: 16 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cabozantinib (XL184)
n=22 participants at risk
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Cardiac disorders
Cardiac disorders - Other
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Colonic obstruction
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Pain
|
4.5%
1/22 • Number of events 1
|
|
Immune system disorders
Anaphylaxis
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Lung infection
|
9.1%
2/22 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.6%
3/22 • Number of events 3
|
|
Nervous system disorders
Myelitis
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Nervous system disorders - Other
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Transient ischemic attacks
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
22.7%
5/22 • Number of events 5
|
Other adverse events
| Measure |
Cabozantinib (XL184)
n=22 participants at risk
Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
11/22 • Number of events 15
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
4.5%
1/22 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.5%
1/22 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
2/22 • Number of events 2
|
|
Endocrine disorders
Hyperthyroidism
|
9.1%
2/22 • Number of events 2
|
|
Endocrine disorders
Hypothyroidism
|
13.6%
3/22 • Number of events 3
|
|
Eye disorders
Blurred vision
|
9.1%
2/22 • Number of events 2
|
|
Eye disorders
Cataract
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
3/22 • Number of events 4
|
|
Gastrointestinal disorders
Anal mucositis
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
45.5%
10/22 • Number of events 12
|
|
Gastrointestinal disorders
Diarrhea
|
72.7%
16/22 • Number of events 32
|
|
Gastrointestinal disorders
Dry mouth
|
22.7%
5/22 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Fecal incontinence
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
18.2%
4/22 • Number of events 4
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
45.5%
10/22 • Number of events 11
|
|
Gastrointestinal disorders
Oral dysesthesia
|
27.3%
6/22 • Number of events 6
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
2/22 • Number of events 2
|
|
Gastrointestinal disorders
Periodontal disease
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Rectal pain
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
31.8%
7/22 • Number of events 7
|
|
General disorders
Chills
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Edema limbs
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Fatigue
|
54.5%
12/22 • Number of events 19
|
|
General disorders
Fever
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Flu like symptoms
|
4.5%
1/22 • Number of events 2
|
|
General disorders
Localized edema
|
4.5%
1/22 • Number of events 3
|
|
General disorders
Non-cardiac chest pain
|
13.6%
3/22 • Number of events 3
|
|
General disorders
Pain
|
31.8%
7/22 • Number of events 10
|
|
Immune system disorders
Serum sickness
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Papulopustular rash
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Penile infection
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Rash pustular
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
4.5%
1/22 • Number of events 1
|
|
Infections and infestations
Skin infection
|
4.5%
1/22 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
2/22 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
13.6%
3/22 • Number of events 4
|
|
Injury, poisoning and procedural complications
Bruising
|
18.2%
4/22 • Number of events 4
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
1/22 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
68.2%
15/22 • Number of events 28
|
|
Investigations
Alkaline phosphatase increased
|
31.8%
7/22 • Number of events 14
|
|
Investigations
Aspartate aminotransferase increased
|
68.2%
15/22 • Number of events 29
|
|
Investigations
Blood bilirubin increased
|
9.1%
2/22 • Number of events 5
|
|
Investigations
Creatinine increased
|
9.1%
2/22 • Number of events 2
|
|
Investigations
Investigations - Other, specify
|
18.2%
4/22 • Number of events 4
|
|
Investigations
Lipase increased
|
31.8%
7/22 • Number of events 12
|
|
Investigations
Lymphocyte count decreased
|
22.7%
5/22 • Number of events 6
|
|
Investigations
Neutrophil count decreased
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Platelet count decreased
|
31.8%
7/22 • Number of events 7
|
|
Investigations
Serum amylase increased
|
13.6%
3/22 • Number of events 3
|
|
Investigations
Weight loss
|
50.0%
11/22 • Number of events 15
|
|
Investigations
White blood cell decreased
|
22.7%
5/22 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
77.3%
17/22 • Number of events 23
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
2/22 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.9%
9/22 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.6%
3/22 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
4/22 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
2/22 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
2/22 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.2%
4/22 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
3/22 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.5%
1/22 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
18.2%
4/22 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.2%
4/22 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
2/22 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.2%
4/22 • Number of events 7
|
|
Nervous system disorders
Concentration impairment
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
22.7%
5/22 • Number of events 6
|
|
Nervous system disorders
Dysesthesia
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
59.1%
13/22 • Number of events 18
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Number of events 3
|
|
Nervous system disorders
Myelitis
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
9.1%
2/22 • Number of events 2
|
|
Psychiatric disorders
Depression
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Personality change
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Psychiatric disorders - Other
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Cystitis noninfective
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
27.3%
6/22 • Number of events 6
|
|
Renal and urinary disorders
Proteinuria
|
31.8%
7/22 • Number of events 8
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
4.5%
1/22 • Number of events 3
|
|
Renal and urinary disorders
Renal calculi
|
4.5%
1/22 • Number of events 2
|
|
Renal and urinary disorders
Urinary frequency
|
9.1%
2/22 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
13.6%
3/22 • Number of events 3
|
|
Renal and urinary disorders
Urinary urgency
|
9.1%
2/22 • Number of events 2
|
|
Renal and urinary disorders
Urine discoloration
|
4.5%
1/22 • Number of events 1
|
|
Reproductive system and breast disorders
Gynecomastia
|
4.5%
1/22 • Number of events 1
|
|
Reproductive system and breast disorders
Perineal pain
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.7%
5/22 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
31.8%
7/22 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
2/22 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
13.6%
3/22 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.6%
3/22 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
45.5%
10/22 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
18.2%
4/22 • Number of events 6
|
|
Vascular disorders
Flushing
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
18.2%
4/22 • Number of events 5
|
|
Vascular disorders
Hypertension
|
22.7%
5/22 • Number of events 7
|
|
Vascular disorders
Vascular disorders - Other
|
4.5%
1/22 • Number of events 1
|
Additional Information
Dr. David C. Smith, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-764-3066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place