Trial Outcomes & Findings for TKI258 in Castrate Resistant Prostate Cancer (NCT NCT00831792)
NCT ID: NCT00831792
Last Updated: 2019-09-11
Results Overview
Three consecutive PSA elevations above nadir or baseline are required for progression. Each increment in PSA should be a minimum of 1 ng/ml and at least 2 weeks apart or will not count. The time of PSA progression will be taken as the time of the first of these PSA elevations that represents an increment by at least 25% above the nadir or baseline. Given that increments in PSA do not always represent treatment failure, particularly when novel agents with uncertain effects on PSA levels are being evaluated, clinical and radiological correlation is recommended at the discretion of the treating physician. In patients with PSA progression alone without clinical or radiological evidence of disease progression, continued therapy on study is at the discretion of the treating physician in consultation with the principal investigator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
From the time of enrollment until 30 days beyond the date of the last study drug administration
Results posted on
2019-09-11
Participant Flow
Castration-Resistant Prostate Cancer patients were enrolled between 2010-2013
Participant milestones
| Measure |
Eligible Patients
All patients enrolled and treated with TKI 258
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Eligible Patients
All patients enrolled and treated with TKI 258
|
|---|---|
|
Overall Study
Not Eligible
|
3
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
TKI258 in Castrate Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
All Patients Enrolled and Treated With TKI 258
n=46 Participants
Patients with castrate-resistant prostate cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of enrollment until 30 days beyond the date of the last study drug administrationPopulation: Patients completed at least 1 cycle of therapy
Three consecutive PSA elevations above nadir or baseline are required for progression. Each increment in PSA should be a minimum of 1 ng/ml and at least 2 weeks apart or will not count. The time of PSA progression will be taken as the time of the first of these PSA elevations that represents an increment by at least 25% above the nadir or baseline. Given that increments in PSA do not always represent treatment failure, particularly when novel agents with uncertain effects on PSA levels are being evaluated, clinical and radiological correlation is recommended at the discretion of the treating physician. In patients with PSA progression alone without clinical or radiological evidence of disease progression, continued therapy on study is at the discretion of the treating physician in consultation with the principal investigator.
Outcome measures
| Measure |
APatients on Observational Study of TKI258
n=23 Participants
Patients with histologically confirmed adenocarcinoma of the prostate with bone metastases
|
|---|---|
|
The Number of Participants With Improvement, Disease Progression or Stable Disease
Bone scan/soft tissue mets improvements at 8 wks
|
6 Participants
|
|
The Number of Participants With Improvement, Disease Progression or Stable Disease
Disease progression
|
4 Participants
|
|
The Number of Participants With Improvement, Disease Progression or Stable Disease
experienced stable disease at 8 weeks
|
13 Participants
|
Adverse Events
All Patients Enrolled and Treated With TKI 258
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients Enrolled and Treated With TKI 258
n=40 participants at risk
Patients with castrate-resistant prostate cancer
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy): Extremity - lower
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Infection with unknown ANC--Select: Urinary tract NOS
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils--Select: Skin (cellulitis)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
Other adverse events
| Measure |
All Patients Enrolled and Treated With TKI 258
n=40 participants at risk
Patients with castrate-resistant prostate cancer
|
|---|---|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
57.5%
23/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Immune system disorders
Allergy/Immunology-Other (Specify)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Endocrine disorders
Alopecia
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
25.0%
10/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Amylase
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Anemia
|
20.0%
8/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Anorexia
|
55.0%
22/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Hepatobiliary disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
37.5%
15/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Ataxia (incoordination)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Skin and subcutaneous tissue disorders
Atrophy, skin
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Immune system disorders
Autoimmune reaction
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Back pain
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Bladder spasms
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Bone pain
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
22.5%
9/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Chest wall pain
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholestremia)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Confusion
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Constipation
|
32.5%
13/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Creatinine
|
17.5%
7/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystitis noninfective
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Dehydration
|
15.0%
6/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Diarrhea
|
77.5%
31/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
DIC (disseminated intravascular coagulation)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
General disorders
Dry mouth/salivary gland (xerostomia)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Dysesthesia
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Dysgeusia
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
27.5%
11/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Edema limbs
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Edema trunk
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Edema: limb
|
30.0%
12/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Edema: trunk/genital
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Fatigue (asthenia, lethargy, malaise)
|
97.5%
39/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9 per liter)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
fibrinogen
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
General disorders
Gastrointestinal-Other (Specity)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Hepatobiliary disorders
GGT (gamma-Glutamyl transpeptidase)
|
20.0%
8/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
Hemoglobin
|
62.5%
25/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Hemoglobinuria
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Hemorrhage, GU--Select (Urinary NOS)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Endocrine disorders
Hot flashes
|
12.5%
5/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
52.5%
21/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Hypertension (Adult)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
32.5%
13/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.5%
9/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Hypotension
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Incontinence
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils--Select (Urinary tract NOS)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Infection (clinically or microbiologically)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Infection without neutropenia
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Infection-Other (Specify)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
INR (International Normalized Ratio of prothrombin time)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Insomnia
|
15.0%
6/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
Leukocytes (Total WBC)
|
20.0%
8/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Lipase
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Localized edema
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
17.5%
7/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Psychiatric disorders
Mood alteration-depression
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Psychiatric disorders
Mood alteration--Select
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Psychiatric disorders
Mood alteration--Select (Depression)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Mucositis oral
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Oral Cavity)
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity - lower)
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) (Whole body/generalized)
|
32.5%
13/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Nausea
|
65.0%
26/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Neurology-Other (Specify)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Neuropathy: sensory
|
30.0%
12/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
12.5%
5/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Non-cardiac chest pain
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain in extremity
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain-Other (Specify)
|
47.5%
19/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Abdomen NOS)
|
12.5%
5/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Back)
|
42.5%
17/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Bone)
|
20.0%
8/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Buttock)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Cardiac/heart)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Chest wall)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Dental/teeth/peridontal)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Extremity-limb)
|
15.0%
6/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Head/headache)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Joint)
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Liver)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Pain NOS)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Pelvis)
|
15.0%
6/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Rectum)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Scalp)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pain--Select (Throat/pharynx/larynx)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Endocrine disorders
Pancreatic endocrine: glucose intolerance
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Paresthesia
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Pelvic pain
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Pericarditis
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
Platelets
|
30.0%
12/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Pleural effusion (non-malignant)
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Proteinuria
|
12.5%
5/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
32.5%
13/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Rigors, chills
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Salivary gland changes/saliva
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia--Select (Atrial fibrillation)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia--Select (Atrial flutter)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia--Select (Sinus tachycardia)
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Nervous system disorders
Syncope (fainting)
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
7.5%
3/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
General disorders
Tooth infection
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
22.5%
9/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Urinary tract pain
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Renal and urinary disorders
Urine color change
|
5.0%
2/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Eye disorders
Vision-blurred vision
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
General disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
14/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
10.0%
4/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Metabolism and nutrition disorders
Weight loss
|
15.0%
6/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
2.5%
1/40 • From the time of enrollment until 30 days beyond the date of the last study drug administration
|
Additional Information
Corn,Paul,M.D. Ph.D. / Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place