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Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT01835145
Recruitment Status : Active, not recruiting
First Posted : April 18, 2013
Results First Posted : April 26, 2019
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
Exelisis
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 Recurrent Uveal Melanoma
Stage III Uveal Melanoma AJCC v7
Stage IIIA Uveal Melanoma AJCC v7
Stage IIIB Uveal Melanoma AJCC v7
Stage IIIC Uveal Melanoma AJCC v7
Stage IV Uveal Melanoma AJCC v7
Interventions Drug: Cabozantinib S-malate
Drug: Dacarbazine
Other: Laboratory Biomarker Analysis
Drug: Temozolomide
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Temozolomide or Dacarbazine)
Hide Arm/Group Description Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Period Title: Overall Study
Started 32 15
Completed 31 15
Not Completed 1 0
Reason Not Completed
Ineligible prior to treatment             1             0
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Temozolomide or Dacarbazine) Total
Hide Arm/Group Description Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. >>

>> If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Total of all reporting groups
Overall Number of Baseline Participants 31 15 46
Hide Baseline Analysis Population Description
All participants that began study treatment are included in the baseline analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants 15 participants 46 participants
60
(30 to 86)
67
(45 to 78)
62.5
(30 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 15 participants 46 participants
Female
14
  45.2%
6
  40.0%
20
  43.5%
Male
17
  54.8%
9
  60.0%
26
  56.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 15 participants 46 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
31
 100.0%
15
 100.0%
46
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 15 participants 46 participants
Canada
8
  25.8%
3
  20.0%
11
  23.9%
United States
23
  74.2%
12
  80.0%
35
  76.1%
1.Primary Outcome
Title Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4)
Hide Description A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The success for each arm will be calculated independently as the number of successes divided by the total number of evaluable patients. A one-sided chi-squared test for a difference in PFS4 proportions will be used to test for a difference between arms.
Time Frame At 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment were included in this analysis.
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Temozolomide or Dacarbazine)
Hide Arm/Group Description:
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

>

> If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 31 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
.323
(.167 to .514)
.267
(.078 to .551)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Cabozantinib-s-malate), Arm II (Temozolomide or Dacarbazine)
Comments A one-sided chi-squared test for a difference in PFS4 rates will be used to test for a difference between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1)
Hide Description The confirmed response rates will be estimated by dividing the number of confirmed responders by the number of evaluable patients. 95% confidence intervals will be calculated.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Temozolomide or Dacarbazine)
Hide Arm/Group Description:
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 31 15
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Percentage of Patients Who Experienced Grade 3+ Adverse Events Regardless of Attribution
Hide Description percentage of patients who experienced grade 3+ adverse events regardless of attribution, graded according to the National Cancer Institute CTCAE version 4.0
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Temozolomide or Dacarbazine)
Hide Arm/Group Description:
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

>

> If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 31 15
Measure Type: Number
Unit of Measure: percentage of patients
51.6 20
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description The distribution of OS time will be estimated using the method of Kaplan Meier.
Time Frame Number of days from registration until death, assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Temozolomide or Dacarbazine)
Hide Arm/Group Description:
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

>

> If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 31 15
Median (95% Confidence Interval)
Unit of Measure: months
6.3
(5.5 to 10.3)
7.2 [1] 
(5.6 to NA)
[1]
The 95% confidence interval upper limit was not estimated (insufficient number of participants with events).
5.Secondary Outcome
Title PFS
Hide Description The distribution of PFS time will be estimated using the method of Kaplan Meier and is defined as the number of days from registration until disease progression (or death). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame Number of days from registration until disease progression (or death), assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Temozolomide or Dacarbazine)
Hide Arm/Group Description:
Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

>

> If temozolomide is not available, patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 31 15
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.8 to 5.3)
1.9
(1.8 to 5.0)
6.Other Pre-specified Outcome
Title Pre-treatment GNAQ/GNA11 and Potentially Other Mutations in Tissue
Hide Description The proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.
Time Frame Baseline
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Pre-treatment Immune Gene Expression in Tissue Defined as T Cell-inflamed, Intermediate and Non-T Cell-inflamed
Hide Description The proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.
Time Frame Baseline
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Cabozantinib-s-malate) Arm II (Temozolomide) Arm II (Dacarbazine)
Hide Arm/Group Description Patients receive 60 mg cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 150 mg/m^2 temozolomide PO daily on days 1-5 of a 28 day cycle. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients receive 1000 mg/m^2/day dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I (Cabozantinib-s-malate) Arm II (Temozolomide) Arm II (Dacarbazine)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/31 (6.45%)      1/11 (9.09%)      0/4 (0.00%)    
Hide Serious Adverse Events
Arm I (Cabozantinib-s-malate) Arm II (Temozolomide) Arm II (Dacarbazine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/31 (48.39%)      6/11 (54.55%)      2/4 (50.00%)    
Endocrine disorders       
Hyperthyroidism  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  1/31 (3.23%)  1 2/11 (18.18%)  2 0/4 (0.00%)  0
Diarrhea  1  1/31 (3.23%)  1 2/11 (18.18%)  2 1/4 (25.00%)  1
Nausea  1  1/31 (3.23%)  2 1/11 (9.09%)  1 1/4 (25.00%)  1
Oral pain  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
General disorders       
Death NOS  1  2/31 (6.45%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Fatigue  1  2/31 (6.45%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Hepatobiliary disorders       
Hepatobiliary disorders - Other, specify  1  2/31 (6.45%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Portal vein thrombosis  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Immune system disorders       
Anaphylaxis  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations       
Appendicitis perforated  1  0/31 (0.00%)  0 1/11 (9.09%)  2 0/4 (0.00%)  0
Enterocolitis infectious  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Lung infection  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  4/31 (12.90%)  5 0/11 (0.00%)  0 0/4 (0.00%)  0
Alkaline phosphatase increased  1  2/31 (6.45%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Aspartate aminotransferase increased  1  4/31 (12.90%)  5 1/11 (9.09%)  1 0/4 (0.00%)  0
Blood bilirubin increased  1  2/31 (6.45%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Creatinine increased  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Ejection fraction decreased  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Lipase increased  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Neutrophil count decreased  1  1/31 (3.23%)  1 0/11 (0.00%)  0 1/4 (25.00%)  1
Platelet count decreased  1  0/31 (0.00%)  0 0/11 (0.00%)  0 1/4 (25.00%)  1
Metabolism and nutrition disorders       
Dehydration  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Hypoalbuminemia  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Hyponatremia  1  2/31 (6.45%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Hypophosphatemia  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Metabolism and nutrition disorders - Other, specify  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Generalized muscle weakness  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Nervous system disorders       
Headache  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Renal and urinary disorders       
Chronic kidney disease  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural effusion  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Sore throat  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders       
Hypertension  1  2/31 (6.45%)  3 0/11 (0.00%)  0 0/4 (0.00%)  0
Thromboembolic event  1  4/31 (12.90%)  4 1/11 (9.09%)  1 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Cabozantinib-s-malate) Arm II (Temozolomide) Arm II (Dacarbazine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/31 (96.77%)      11/11 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  2/31 (6.45%)  4 6/11 (54.55%)  9 0/4 (0.00%)  0
Cardiac disorders       
Cardiac disorders - Other, specify  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Left ventricular systolic dysfunction  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Palpitations  1  2/31 (6.45%)  3 0/11 (0.00%)  0 0/4 (0.00%)  0
Sinus bradycardia  1  0/31 (0.00%)  0 1/11 (9.09%)  3 0/4 (0.00%)  0
Ear and labyrinth disorders       
Tinnitus  1  1/31 (3.23%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Endocrine disorders       
Hyperthyroidism  1  2/31 (6.45%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Hypothyroidism  1  3/31 (9.68%)  17 2/11 (18.18%)  6 0/4 (0.00%)  0
Eye disorders       
Dry eye  1  0/31 (0.00%)  0 1/11 (9.09%)  5 0/4 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Abdominal pain  1  2/31 (6.45%)  2 3/11 (27.27%)  6 0/4 (0.00%)  0
Constipation  1  3/31 (9.68%)  6 3/11 (27.27%)  6 0/4 (0.00%)  0
Diarrhea  1  15/31 (48.39%)  41 4/11 (36.36%)  6 2/4 (50.00%)  5
Dry mouth  1  4/31 (12.90%)  5 1/11 (9.09%)  3 0/4 (0.00%)  0
Dyspepsia  1  2/31 (6.45%)  4 2/11 (18.18%)  3 0/4 (0.00%)  0
Dysphagia  1  0/31 (0.00%)  0 2/11 (18.18%)  3 0/4 (0.00%)  0
Flatulence  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Gastroesophageal reflux disease  1  1/31 (3.23%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  0/31 (0.00%)  0 1/11 (9.09%)  4 0/4 (0.00%)  0
Mucositis oral  1  4/31 (12.90%)  5 0/11 (0.00%)  0 0/4 (0.00%)  0
Nausea  1  11/31 (35.48%)  20 6/11 (54.55%)  16 1/4 (25.00%)  1
Oral pain  1  2/31 (6.45%)  2 1/11 (9.09%)  4 0/4 (0.00%)  0
Vomiting  1  6/31 (19.35%)  6 4/11 (36.36%)  6 1/4 (25.00%)  3
General disorders       
Chills  1  0/31 (0.00%)  0 1/11 (9.09%)  3 1/4 (25.00%)  6
Edema limbs  1  1/31 (3.23%)  1 1/11 (9.09%)  1 0/4 (0.00%)  0
Fatigue  1  20/31 (64.52%)  51 10/11 (90.91%)  31 3/4 (75.00%)  5
General disorders and administration site conditions - Other, specify  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Non-cardiac chest pain  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Pain  1  3/31 (9.68%)  5 1/11 (9.09%)  1 0/4 (0.00%)  0
Hepatobiliary disorders       
Portal vein thrombosis  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations       
Sinusitis  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Skin infection  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Upper respiratory infection  1  0/31 (0.00%)  0 1/11 (9.09%)  2 0/4 (0.00%)  0
Urinary tract infection  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  21/31 (67.74%)  71 6/11 (54.55%)  17 1/4 (25.00%)  3
Alkaline phosphatase increased  1  5/31 (16.13%)  9 3/11 (27.27%)  6 0/4 (0.00%)  0
Aspartate aminotransferase increased  1  26/31 (83.87%)  85 10/11 (90.91%)  26 2/4 (50.00%)  4
Blood bilirubin increased  1  6/31 (19.35%)  10 3/11 (27.27%)  4 2/4 (50.00%)  3
Creatinine increased  1  2/31 (6.45%)  4 1/11 (9.09%)  4 0/4 (0.00%)  0
Electrocardiogram QT corrected interval prolonged  1  1/31 (3.23%)  1 0/11 (0.00%)  0 1/4 (25.00%)  1
Hemoglobin increased  1  1/31 (3.23%)  1 1/11 (9.09%)  1 0/4 (0.00%)  0
Investigations - Other, specify  1  1/31 (3.23%)  3 2/11 (18.18%)  10 0/4 (0.00%)  0
Lipase increased  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Lymphocyte count decreased  1  2/31 (6.45%)  3 3/11 (27.27%)  7 0/4 (0.00%)  0
Neutrophil count decreased  1  7/31 (22.58%)  13 2/11 (18.18%)  6 2/4 (50.00%)  5
Platelet count decreased  1  12/31 (38.71%)  27 5/11 (45.45%)  9 2/4 (50.00%)  6
Weight loss  1  6/31 (19.35%)  9 2/11 (18.18%)  9 0/4 (0.00%)  0
White blood cell decreased  1  3/31 (9.68%)  5 4/11 (36.36%)  8 0/4 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  7/31 (22.58%)  14 3/11 (27.27%)  10 0/4 (0.00%)  0
Dehydration  1  3/31 (9.68%)  3 0/11 (0.00%)  0 0/4 (0.00%)  0
Hyperglycemia  1  4/31 (12.90%)  6 1/11 (9.09%)  1 0/4 (0.00%)  0
Hyperkalemia  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Hypoalbuminemia  1  3/31 (9.68%)  3 4/11 (36.36%)  9 0/4 (0.00%)  0
Hypokalemia  1  1/31 (3.23%)  1 2/11 (18.18%)  4 0/4 (0.00%)  0
Hyponatremia  1  3/31 (9.68%)  4 3/11 (27.27%)  5 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/31 (9.68%)  4 1/11 (9.09%)  1 0/4 (0.00%)  0
Back pain  1  1/31 (3.23%)  2 2/11 (18.18%)  4 0/4 (0.00%)  0
Generalized muscle weakness  1  2/31 (6.45%)  2 1/11 (9.09%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1  1/31 (3.23%)  10 0/11 (0.00%)  0 0/4 (0.00%)  0
Myalgia  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Neck pain  1  1/31 (3.23%)  2 2/11 (18.18%)  4 0/4 (0.00%)  0
Pain in extremity  1  0/31 (0.00%)  0 1/11 (9.09%)  2 0/4 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Nervous system disorders       
Dizziness  1  2/31 (6.45%)  6 1/11 (9.09%)  1 0/4 (0.00%)  0
Dysgeusia  1  4/31 (12.90%)  11 1/11 (9.09%)  1 0/4 (0.00%)  0
Headache  1  2/31 (6.45%)  4 1/11 (9.09%)  3 0/4 (0.00%)  0
Hypersomnia  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders - Other, specify  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Peripheral sensory neuropathy  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Psychiatric disorders       
Depression  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Insomnia  1  1/31 (3.23%)  1 1/11 (9.09%)  3 0/4 (0.00%)  0
Renal and urinary disorders       
Hematuria  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Proteinuria  1  6/31 (19.35%)  10 0/11 (0.00%)  0 1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/31 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0
Dyspnea  1  0/31 (0.00%)  0 2/11 (18.18%)  8 0/4 (0.00%)  0
Epistaxis  1  1/31 (3.23%)  1 0/11 (0.00%)  0 0/4 (0.00%)  0
Hoarseness  1  1/31 (3.23%)  1 2/11 (18.18%)  5 0/4 (0.00%)  0
Laryngeal inflammation  1  0/31 (0.00%)  0 1/11 (9.09%)  5 0/4 (0.00%)  0
Productive cough  1  0/31 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0
Sore throat  1  2/31 (6.45%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dry skin  1  3/31 (9.68%)  9 1/11 (9.09%)  1 0/4 (0.00%)  0
Nail discoloration  1  1/31 (3.23%)  4 0/11 (0.00%)  0 0/4 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome  1  2/31 (6.45%)  5 1/11 (9.09%)  1 0/4 (0.00%)  0
Pruritus  1  1/31 (3.23%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0
Rash acneiform  1  1/31 (3.23%)  1 2/11 (18.18%)  2 0/4 (0.00%)  0
Rash maculo-papular  1  1/31 (3.23%)  2 1/11 (9.09%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1  3/31 (9.68%)  4 1/11 (9.09%)  3 0/4 (0.00%)  0
Vascular disorders       
Hot flashes  1  0/31 (0.00%)  0 1/11 (9.09%)  3 0/4 (0.00%)  0
Hypertension  1  18/31 (58.06%)  61 5/11 (45.45%)  17 1/4 (25.00%)  2
Hypotension  1  1/31 (3.23%)  1 1/11 (9.09%)  1 0/4 (0.00%)  0
Thromboembolic event  1  1/31 (3.23%)  4 0/11 (0.00%)  0 0/4 (0.00%)  0
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Jason J. Luke, M.D.
Organization: Alliance for Clinical Trials in Oncology
EMail: jluke@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01835145    
Other Study ID Numbers: NCI-2013-00821
NCI-2013-00821 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB-A091201
A091201
A091201 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A091201 ( 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: July 31, 2018
Results First Posted: April 26, 2019
Last Update Posted: September 24, 2021