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Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT01835158
Recruitment Status : Active, not recruiting
First Posted : April 18, 2013
Results First Posted : December 21, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Clear Cell Renal Cell Carcinoma
Metastatic Kidney Carcinoma
Stage III Renal Cell Cancer AJCC v7
Stage IV Renal Cell Cancer AJCC v7
Interventions Drug: Cabozantinib S-malate
Other: Laboratory Biomarker Analysis
Drug: Sunitinib Malate
Enrollment 157
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate)
Hide Arm/Group Description Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 79 78
Completed 78 72
Not Completed 1 6
Reason Not Completed
Withdrawal by Subject             1             6
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate) Total
Hide Arm/Group Description Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 79 78 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 79 participants 78 participants 157 participants
63
(40 to 82)
64
(31 to 87)
63
(31 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 78 participants 157 participants
Female
13
  16.5%
21
  26.9%
34
  21.7%
Male
66
  83.5%
57
  73.1%
123
  78.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 78 participants 157 participants
American Indian or Alaska Native
1
   1.3%
0
   0.0%
1
   0.6%
Asian
1
   1.3%
0
   0.0%
1
   0.6%
Native Hawaiian or Other Pacific Islander
1
   1.3%
0
   0.0%
1
   0.6%
Black or African American
3
   3.8%
2
   2.6%
5
   3.2%
White
70
  88.6%
75
  96.2%
145
  92.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   3.8%
1
   1.3%
4
   2.5%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that were enrolled on to study.
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate)
Hide Arm/Group Description:
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 79 78
Median (95% Confidence Interval)
Unit of Measure: Months
8.2
(6.2 to 8.8)
5.6
(3.4 to 8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Cabozantinib-s-malate), Arm II (Sunitinib Malate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
.46 to .95
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival (OS)
Hide Description The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate)
Hide Arm/Group Description:
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 79 78
Median (95% Confidence Interval)
Unit of Measure: Months
30.3
(14.6 to 35.0)
21.8
(16.3 to 27.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Cabozantinib-s-malate), Arm II (Sunitinib Malate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.50 to 1.26
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rates
Hide Description Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients.
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate)
Hide Arm/Group Description:
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 79 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.33
(0.23 to 0.44)
0.12
(0.054 to 0.21)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate)
Hide Arm/Group Description Patients receive cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/78 (50.00%)      39/72 (54.17%)    
Blood and lymphatic system disorders     
Anemia  1  2/78 (2.56%)  2 1/72 (1.39%)  1
Blood and lymph sys disorders - Oth Spec  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  0/78 (0.00%)  0 2/72 (2.78%)  2
Palpitations  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Endocrine disorders     
Hyperthyroidism  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Abdominal pain  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Colitis  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Colonic perforation  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Constipation  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Diarrhea  1  4/78 (5.13%)  4 5/72 (6.94%)  6
Esophageal pain  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Gastric hemorrhage  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Gastric ulcer  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Jejunal perforation  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Mucositis oral  1  2/78 (2.56%)  3 1/72 (1.39%)  1
Nausea  1  2/78 (2.56%)  2 4/72 (5.56%)  5
Pancreatitis  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Small intestinal obstruction  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Vomiting  1  1/78 (1.28%)  1 4/72 (5.56%)  5
General disorders     
Death NOS  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Edema limbs  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Fatigue  1  1/78 (1.28%)  1 5/72 (6.94%)  6
Fever  1  0/78 (0.00%)  0 2/72 (2.78%)  2
Pain  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Hepatobiliary disorders     
Gallbladder pain  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Portal vein thrombosis  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Infections and infestations     
Bladder infection  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Encephalitis infection  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Lung infection  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Nail infection  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Sepsis  1  2/78 (2.56%)  2 1/72 (1.39%)  1
Skin infection  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Tooth infection  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Inj, pois and proced complic - Oth spec  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  2/78 (2.56%)  3 2/72 (2.78%)  2
Alkaline phosphatase increased  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Aspartate aminotransferase increased  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Blood bilirubin increased  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Creatinine increased  1  2/78 (2.56%)  2 0/72 (0.00%)  0
ECG QT corrected interval prolonged  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Investigations - Other, specify  1  0/78 (0.00%)  0 2/72 (2.78%)  2
Lipase increased  1  0/78 (0.00%)  0 2/72 (2.78%)  2
Neutrophil count decreased  1  0/78 (0.00%)  0 3/72 (4.17%)  3
Platelet count decreased  1  0/78 (0.00%)  0 3/72 (4.17%)  3
Serum amylase increased  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Weight loss  1  3/78 (3.85%)  3 0/72 (0.00%)  0
White blood cell decreased  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Metabolism and nutrition disorders     
Anorexia  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Dehydration  1  3/78 (3.85%)  3 2/72 (2.78%)  2
Hypercalcemia  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Hyperglycemia  1  1/78 (1.28%)  1 1/72 (1.39%)  2
Hyperkalemia  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Hypocalcemia  1  2/78 (2.56%)  2 1/72 (1.39%)  1
Hypoglycemia  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Hypokalemia  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Hypomagnesemia  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Hyponatremia  1  1/78 (1.28%)  2 2/72 (2.78%)  3
Hypophosphatemia  1  3/78 (3.85%)  4 3/72 (4.17%)  3
Metabolism, nutrition disord - Oth spec  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Arthralgia  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Bone pain  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Chest wall pain  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Generalized muscle weakness  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Pain in extremity  1  2/78 (2.56%)  2 1/72 (1.39%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, mal, uncpec - Oth spec  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Tumor pain  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Dysgeusia  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Facial muscle weakness  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Headache  1  0/78 (0.00%)  0 3/72 (4.17%)  3
Hypoglossal nerve disorder  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Intracranial hemorrhage  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Nervous system disorders - Oth spec  1  1/78 (1.28%)  1 2/72 (2.78%)  2
Somnolence  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Stroke  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Syncope  1  3/78 (3.85%)  3 0/72 (0.00%)  0
Transient ischemic attacks  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Psychiatric disorders     
Confusion  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Depression  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  4/78 (5.13%)  4 2/72 (2.78%)  2
Chronic kidney disease  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Proteinuria  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Renal and urinary disorders - Oth spec  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchial obstruction  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Cough  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Dyspnea  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Pleural effusion  1  0/78 (0.00%)  0 2/72 (2.78%)  2
Respiratory failure  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrm  1  4/78 (5.13%)  5 1/72 (1.39%)  1
Skin ulceration  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Vascular disorders     
Hypertension  1  8/78 (10.26%)  9 3/72 (4.17%)  3
Hypotension  1  3/78 (3.85%)  3 1/72 (1.39%)  1
Thromboembolic event  1  7/78 (8.97%)  7 1/72 (1.39%)  1
Vascular disorders - Other, specify  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Vasculitis  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Cabozantinib-s-malate) Arm II (Sunitinib Malate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/78 (97.44%)      68/72 (94.44%)    
Blood and lymphatic system disorders     
Anemia  1  29/78 (37.18%)  94 32/72 (44.44%)  103
Blood and lymph sys disorders - Oth Spec  1  2/78 (2.56%)  3 1/72 (1.39%)  1
Thrombotic thrombocytopenic purpura  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Cardiac disorders     
Atrial fibrillation  1  2/78 (2.56%)  7 0/72 (0.00%)  0
Atrial flutter  1  1/78 (1.28%)  2 0/72 (0.00%)  0
Heart failure  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Palpitations  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Sinus bradycardia  1  2/78 (2.56%)  3 2/72 (2.78%)  3
Sinus tachycardia  1  1/78 (1.28%)  2 1/72 (1.39%)  1
Ear and labyrinth disorders     
Ear and labyrinth disorders - Oth spec  1  1/78 (1.28%)  2 0/72 (0.00%)  0
Ear pain  1  1/78 (1.28%)  2 0/72 (0.00%)  0
Hearing impaired  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Tinnitus  1  1/78 (1.28%)  5 0/72 (0.00%)  0
Endocrine disorders     
Endocrine disorders - Other, specify  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Hyperthyroidism  1  4/78 (5.13%)  12 2/72 (2.78%)  3
Hypothyroidism  1  19/78 (24.36%)  50 4/72 (5.56%)  12
Eye disorders     
Blurred vision  1  2/78 (2.56%)  2 2/72 (2.78%)  3
Dry eye  1  1/78 (1.28%)  1 2/72 (2.78%)  2
Eye disorders - Other, specify  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Floaters  1  0/78 (0.00%)  0 1/72 (1.39%)  2
Glaucoma  1  1/78 (1.28%)  4 0/72 (0.00%)  0
Watering eyes  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Abdominal pain  1  10/78 (12.82%)  27 8/72 (11.11%)  12
Anal hemorrhage  1  0/78 (0.00%)  0 1/72 (1.39%)  2
Anal mucositis  1  0/78 (0.00%)  0 1/72 (1.39%)  2
Bloating  1  2/78 (2.56%)  2 1/72 (1.39%)  1
Colonic obstruction  1  1/78 (1.28%)  2 1/72 (1.39%)  1
Constipation  1  16/78 (20.51%)  29 11/72 (15.28%)  15
Dental caries  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Diarrhea  1  54/78 (69.23%)  305 38/72 (52.78%)  96
Dry mouth  1  16/78 (20.51%)  69 9/72 (12.50%)  14
Dyspepsia  1  22/78 (28.21%)  56 12/72 (16.67%)  23
Dysphagia  1  5/78 (6.41%)  8 2/72 (2.78%)  3
Esophagitis  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Fecal incontinence  1  2/78 (2.56%)  18 0/72 (0.00%)  0
Flatulence  1  4/78 (5.13%)  26 4/72 (5.56%)  6
Gastritis  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Gastroesophageal reflux disease  1  6/78 (7.69%)  23 6/72 (8.33%)  10
Gastrointestinal disorders - Oth spec  1  6/78 (7.69%)  9 6/72 (8.33%)  15
Gastrointestinal pain  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Gastroparesis  1  0/78 (0.00%)  0 1/72 (1.39%)  2
Gingival pain  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Hemorrhoids  1  2/78 (2.56%)  3 0/72 (0.00%)  0
Mucositis oral  1  30/78 (38.46%)  63 21/72 (29.17%)  50
Nausea  1  25/78 (32.05%)  77 26/72 (36.11%)  40
Oral dysesthesia  1  4/78 (5.13%)  14 2/72 (2.78%)  14
Oral hemorrhage  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Oral pain  1  9/78 (11.54%)  12 5/72 (6.94%)  6
Pancreatitis  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Rectal pain  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Stomach pain  1  3/78 (3.85%)  4 1/72 (1.39%)  1
Toothache  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Vomiting  1  18/78 (23.08%)  29 14/72 (19.44%)  21
General disorders     
Chills  1  1/78 (1.28%)  1 4/72 (5.56%)  4
Edema face  1  2/78 (2.56%)  4 1/72 (1.39%)  3
Edema limbs  1  7/78 (8.97%)  38 10/72 (13.89%)  17
Facial pain  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Fatigue  1  65/78 (83.33%)  414 58/72 (80.56%)  215
Fever  1  3/78 (3.85%)  3 1/72 (1.39%)  1
Flu like symptoms  1  4/78 (5.13%)  4 3/72 (4.17%)  4
Gait disturbance  1  1/78 (1.28%)  3 1/72 (1.39%)  3
Gen disord and admin site conds-Oth spec  1  3/78 (3.85%)  5 5/72 (6.94%)  6
Localized edema  1  2/78 (2.56%)  2 1/72 (1.39%)  1
Non-cardiac chest pain  1  2/78 (2.56%)  2 2/72 (2.78%)  2
Pain  1  8/78 (10.26%)  11 5/72 (6.94%)  12
Sudden death NOS  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Immune system disorders     
Allergic reaction  1  1/78 (1.28%)  3 0/72 (0.00%)  0
Infections and infestations     
Bladder infection  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Corneal infection  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Gum infection  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Infections and infestations - Oth spec  1  5/78 (6.41%)  6 5/72 (6.94%)  6
Lung infection  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Mucosal infection  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Otitis externa  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Papulopustular rash  1  0/78 (0.00%)  0 4/72 (5.56%)  5
Paronychia  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Pharyngitis  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Sinusitis  1  1/78 (1.28%)  3 1/72 (1.39%)  1
Skin infection  1  4/78 (5.13%)  6 1/72 (1.39%)  1
Stoma site infection  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Tooth infection  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Upper respiratory infection  1  1/78 (1.28%)  2 0/72 (0.00%)  0
Urinary tract infection  1  0/78 (0.00%)  0 4/72 (5.56%)  4
Injury, poisoning and procedural complications     
Bruising  1  4/78 (5.13%)  12 0/72 (0.00%)  0
Fall  1  3/78 (3.85%)  3 0/72 (0.00%)  0
Fracture  1  1/78 (1.28%)  5 0/72 (0.00%)  0
Inj, pois and proced complic - Oth spec  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Venous injury  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Wound complication  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Wound dehiscence  1  0/78 (0.00%)  0 2/72 (2.78%)  2
Investigations     
Activated partial throm time prolonged  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Alanine aminotransferase increased  1  43/78 (55.13%)  135 19/72 (26.39%)  32
Alkaline phosphatase increased  1  10/78 (12.82%)  17 8/72 (11.11%)  10
Aspartate aminotransferase increased  1  49/78 (62.82%)  192 23/72 (31.94%)  36
Blood bilirubin increased  1  11/78 (14.10%)  18 4/72 (5.56%)  8
CD4 lymphocytes decreased  1  1/78 (1.28%)  1 0/72 (0.00%)  0
CPK increased  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Cholesterol high  1  2/78 (2.56%)  6 0/72 (0.00%)  0
Creatinine increased  1  18/78 (23.08%)  100 16/72 (22.22%)  55
ECG QT corrected interval prolonged  1  4/78 (5.13%)  6 5/72 (6.94%)  5
Ejection fraction decreased  1  1/78 (1.28%)  1 0/72 (0.00%)  0
INR increased  1  2/78 (2.56%)  7 1/72 (1.39%)  1
Investigations - Other, specify  1  7/78 (8.97%)  22 2/72 (2.78%)  2
Lipase increased  1  2/78 (2.56%)  6 1/72 (1.39%)  1
Lymphocyte count decreased  1  11/78 (14.10%)  24 14/72 (19.44%)  24
Neutrophil count decreased  1  12/78 (15.38%)  35 23/72 (31.94%)  93
Platelet count decreased  1  32/78 (41.03%)  131 43/72 (59.72%)  103
Serum amylase increased  1  2/78 (2.56%)  6 0/72 (0.00%)  0
Weight gain  1  0/78 (0.00%)  0 2/72 (2.78%)  3
Weight loss  1  28/78 (35.90%)  145 12/72 (16.67%)  32
White blood cell decreased  1  10/78 (12.82%)  39 24/72 (33.33%)  86
Metabolism and nutrition disorders     
Anorexia  1  37/78 (47.44%)  92 23/72 (31.94%)  46
Dehydration  1  7/78 (8.97%)  10 6/72 (8.33%)  6
Hypercalcemia  1  2/78 (2.56%)  2 3/72 (4.17%)  3
Hyperglycemia  1  16/78 (20.51%)  30 11/72 (15.28%)  47
Hyperkalemia  1  7/78 (8.97%)  11 7/72 (9.72%)  9
Hypermagnesemia  1  0/78 (0.00%)  0 3/72 (4.17%)  4
Hypernatremia  1  4/78 (5.13%)  5 1/72 (1.39%)  1
Hypertriglyceridemia  1  0/78 (0.00%)  0 1/72 (1.39%)  5
Hyperuricemia  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Hypoalbuminemia  1  17/78 (21.79%)  47 13/72 (18.06%)  19
Hypocalcemia  1  16/78 (20.51%)  62 10/72 (13.89%)  14
Hypoglycemia  1  3/78 (3.85%)  4 0/72 (0.00%)  0
Hypokalemia  1  13/78 (16.67%)  35 5/72 (6.94%)  5
Hypomagnesemia  1  19/78 (24.36%)  92 8/72 (11.11%)  20
Hyponatremia  1  12/78 (15.38%)  25 15/72 (20.83%)  24
Hypophosphatemia  1  19/78 (24.36%)  62 11/72 (15.28%)  21
Metabolism, nutrition disord - Oth spec  1  3/78 (3.85%)  6 1/72 (1.39%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/78 (8.97%)  26 6/72 (8.33%)  10
Back pain  1  8/78 (10.26%)  20 5/72 (6.94%)  7
Bone pain  1  5/78 (6.41%)  16 2/72 (2.78%)  2
Buttock pain  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Chest wall pain  1  2/78 (2.56%)  3 1/72 (1.39%)  1
Flank pain  1  1/78 (1.28%)  4 2/72 (2.78%)  3
Generalized muscle weakness  1  2/78 (2.56%)  7 7/72 (9.72%)  9
Joint range of motion decreased  1  1/78 (1.28%)  8 0/72 (0.00%)  0
Muscle weakness lower limb  1  1/78 (1.28%)  16 2/72 (2.78%)  4
Muscle weakness upper limb  1  0/78 (0.00%)  0 1/72 (1.39%)  2
Musculoskeletal, conn tissue - Oth spec  1  4/78 (5.13%)  33 2/72 (2.78%)  3
Myalgia  1  7/78 (8.97%)  52 5/72 (6.94%)  6
Neck pain  1  2/78 (2.56%)  3 3/72 (4.17%)  3
Pain in extremity  1  8/78 (10.26%)  16 6/72 (8.33%)  9
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Nervous system disorders     
Ataxia  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Concentration impairment  1  1/78 (1.28%)  2 0/72 (0.00%)  0
Dizziness  1  17/78 (21.79%)  32 15/72 (20.83%)  21
Dysgeusia  1  32/78 (41.03%)  98 21/72 (29.17%)  58
Dysphasia  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Headache  1  9/78 (11.54%)  22 9/72 (12.50%)  16
Hypersomnia  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Memory impairment  1  3/78 (3.85%)  8 0/72 (0.00%)  0
Nervous system disorders - Oth spec  1  3/78 (3.85%)  4 1/72 (1.39%)  1
Neuralgia  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Paresthesia  1  4/78 (5.13%)  14 1/72 (1.39%)  1
Peripheral motor neuropathy  1  2/78 (2.56%)  6 0/72 (0.00%)  0
Peripheral sensory neuropathy  1  8/78 (10.26%)  41 4/72 (5.56%)  4
Somnolence  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Syncope  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Transient ischemic attacks  1  0/78 (0.00%)  0 2/72 (2.78%)  2
Tremor  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Psychiatric disorders     
Anxiety  1  7/78 (8.97%)  13 3/72 (4.17%)  4
Confusion  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Depression  1  4/78 (5.13%)  8 4/72 (5.56%)  7
Insomnia  1  8/78 (10.26%)  13 6/72 (8.33%)  11
Restlessness  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  2/78 (2.56%)  11 1/72 (1.39%)  1
Chronic kidney disease  1  2/78 (2.56%)  18 4/72 (5.56%)  13
Cystitis noninfective  1  0/78 (0.00%)  0 1/72 (1.39%)  2
Hematuria  1  2/78 (2.56%)  4 2/72 (2.78%)  5
Hemoglobinuria  1  0/78 (0.00%)  0 1/72 (1.39%)  2
Proteinuria  1  6/78 (7.69%)  14 9/72 (12.50%)  12
Renal and urinary disorders - Oth spec  1  1/78 (1.28%)  3 1/72 (1.39%)  4
Urinary frequency  1  2/78 (2.56%)  18 2/72 (2.78%)  2
Urinary incontinence  1  1/78 (1.28%)  4 0/72 (0.00%)  0
Urinary urgency  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Urine discoloration  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Reproductive system and breast disorders     
Erectile dysfunction  1  1/78 (1.28%)  4 0/72 (0.00%)  0
Genital edema  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Gynecomastia  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Pelvic pain  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Testicular pain  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Uterine hemorrhage  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  2/78 (2.56%)  4 0/72 (0.00%)  0
Atelectasis  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Cough  1  9/78 (11.54%)  17 4/72 (5.56%)  4
Dyspnea  1  13/78 (16.67%)  33 12/72 (16.67%)  16
Epistaxis  1  8/78 (10.26%)  9 3/72 (4.17%)  4
Hiccups  1  2/78 (2.56%)  2 0/72 (0.00%)  0
Hoarseness  1  11/78 (14.10%)  32 1/72 (1.39%)  1
Hypoxia  1  0/78 (0.00%)  0 1/72 (1.39%)  1
Nasal congestion  1  2/78 (2.56%)  2 2/72 (2.78%)  3
Pharyngeal hemorrhage  1  1/78 (1.28%)  5 0/72 (0.00%)  0
Pleural effusion  1  1/78 (1.28%)  3 0/72 (0.00%)  0
Productive cough  1  6/78 (7.69%)  19 1/72 (1.39%)  1
Resp, thoracic, mediastinal - Oth spec  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Sleep apnea  1  0/78 (0.00%)  0 1/72 (1.39%)  2
Sore throat  1  5/78 (6.41%)  11 2/72 (2.78%)  2
Voice alteration  1  8/78 (10.26%)  19 0/72 (0.00%)  0
Wheezing  1  2/78 (2.56%)  10 0/72 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  13/78 (16.67%)  42 2/72 (2.78%)  6
Bullous dermatitis  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Dry skin  1  16/78 (20.51%)  50 7/72 (9.72%)  8
Pain of skin  1  1/78 (1.28%)  1 1/72 (1.39%)  2
Palmar-plantar erythrodysesthesia syndrm  1  33/78 (42.31%)  119 24/72 (33.33%)  100
Photosensitivity  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Pruritus  1  4/78 (5.13%)  16 4/72 (5.56%)  4
Rash acneiform  1  12/78 (15.38%)  27 3/72 (4.17%)  3
Rash maculo-papular  1  14/78 (17.95%)  26 9/72 (12.50%)  19
Skin and subcut tissue disord - Oth spec  1  16/78 (20.51%)  71 8/72 (11.11%)  17
Skin hyperpigmentation  1  1/78 (1.28%)  2 1/72 (1.39%)  3
Skin hypopigmentation  1  2/78 (2.56%)  3 0/72 (0.00%)  0
Skin ulceration  1  2/78 (2.56%)  5 2/72 (2.78%)  3
Surgical and medical proced - Oth spec  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Vascular disorders     
Flushing  1  1/78 (1.28%)  11 0/72 (0.00%)  0
Hot flashes  1  0/78 (0.00%)  0 2/72 (2.78%)  2
Hypertension  1  64/78 (82.05%)  328 49/72 (68.06%)  193
Hypotension  1  5/78 (6.41%)  5 2/72 (2.78%)  2
Peripheral ischemia  1  1/78 (1.28%)  1 0/72 (0.00%)  0
Thromboembolic event  1  1/78 (1.28%)  1 1/72 (1.39%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Toni K. Choueiri, MD
Organization: Harvard
Phone: (617) 632-5456
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01835158     History of Changes
Other Study ID Numbers: NCI-2013-00820
NCI-2013-00820 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
A031203
A031203 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A031203 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: April 16, 2013
First Posted: April 18, 2013
Results First Submitted: October 23, 2018
Results First Posted: December 21, 2018
Last Update Posted: April 12, 2019