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Trial record 1 of 1 for:    NCT01835223
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Tivozanib in Treating Patients With Liver Cancer That Is Metastatic or Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT01835223
Recruitment Status : Completed
First Posted : April 18, 2013
Results First Posted : October 28, 2020
Last Update Posted : October 28, 2020
Sponsor:
Collaborators:
National Comprehensive Cancer Network
AVEO Pharmaceuticals, Inc.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Adult Hepatocellular Carcinoma
Non-Resectable Hepatocellular Carcinoma
Interventions Drug: Tivozanib (1mg)
Drug: Tivozanib (1.5mg)
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Hide Arm/Group Description

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Period Title: Overall Study
Started 30 3
Completed 21 2
Not Completed 9 1
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             2             0
Disease progression             2             1
Became Inelligible             4             0
Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg) Total
Hide Arm/Group Description

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Total of all reporting groups
Overall Number of Baseline Participants 24 3 27
Hide Baseline Analysis Population Description
Only 27 patient received any treatment.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 3 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  37.5%
1
  33.3%
10
  37.0%
>=65 years
15
  62.5%
2
  66.7%
17
  63.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 3 participants 27 participants
66.2  (5.5) 65.5  (11.4) 65.6  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 3 participants 27 participants
Female
1
   4.2%
0
   0.0%
1
   3.7%
Male
23
  95.8%
3
 100.0%
26
  96.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 3 participants 27 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
1
   4.2%
0
   0.0%
1
   3.7%
White
22
  91.7%
3
 100.0%
25
  92.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.2%
0
   0.0%
1
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 3 participants 27 participants
24 3 27
ECOG Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 3 participants 27 participants
0:Fully active, able to carry on all pre-disease performance without restriction. 14 2 16
1: Restricted in physically strenuous, but able for work of light or sedentary nature 9 1 10
[1]
Measure Description:

ECOG 0: Fully active, able to carry on all pre-disease performance without restriction.

ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.

1.Primary Outcome
Title PFS, Assessed Using Standard RECIST Criteria
Hide Description Will be descriptively analyzed using standard Kaplan-Meier estimation along with the corresponding descriptive statistics and 95% confidence intervals.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was only assessed as part of the Phase II study - which was conducted on the Tivozanib 1mg arm.
Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Hide Arm/Group Description:

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Overall Number of Participants Analyzed 19 0
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
58
(33 to 76)
2.Secondary Outcome
Title Clinical Benefit Rate (CR, PR, and SD) by RECIST
Hide Description The number of patients achieving clinical benefit (CR, PR, or SD by RECIST).
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description

This outcome was only assessed as part of the Phase II study - which was conducted on the Tivozanib 1mg arm.

Only 19 subjects were evaluable for the primary or secondary end-points.

Arm/Group Title Treatment (Tivozanib - 1 mg) Treatment (Tivozanib - 1.5 mg)
Hide Arm/Group Description:

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tivozanib (1mg): Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tivozanib (1.5mg): Given PO

Overall Number of Participants Analyzed 19 0
Measure Type: Count of Participants
Unit of Measure: Participants
12
  63.2%
3.Secondary Outcome
Title Incidence of Adverse Events and Toxicities, Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4
Hide Description Toxicity frequency will be tabulated by grade across all dose levels and cycles for all patients in the safety sample and for the subset treated at the recommended phase 2 dose.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description

This outcome was only assessed as part of the Phase II study - which was conducted on the Tivozanib 1mg arm.

Only 19 subjects were evaluable for the primary or secondary end-points.

Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Hide Arm/Group Description:

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Overall Number of Participants Analyzed 19 0
Measure Type: Count of Participants
Unit of Measure: Participants
19
 100.0%
4.Secondary Outcome
Title Overall Survival Rate
Hide Description Overall survival is defined as the time from treatment until death or last follow-up.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description

This outcome was only assessed as part of the Phase II study - which was conducted on the Tivozanib 1mg arm.

Only 19 subjects were evaluable for the primary or secondary end-points.

Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Hide Arm/Group Description:

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Overall Number of Participants Analyzed 19 0
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percent probability
0.40
(0.19 to 0.60)
5.Other Pre-specified Outcome
Title AFP Response
Hide Description Defined as an AFP decrease greater than 50%.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description

This outcome was only assessed as part of the Phase II study - which was conducted on the Tivozanib 1mg arm.

Only 19 subjects were evaluable for the primary or secondary end-points.

Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Hide Arm/Group Description:

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Overall Number of Participants Analyzed 19 0
Measure Type: Count of Participants
Unit of Measure: Participants
4
  21.1%
6.Other Pre-specified Outcome
Title Antiviral Effects (if Any in Those With HBV or HCV Associated HCC)
Hide Description [Not Specified]
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to funding limitations, this outcome was not assessed.
Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Hide Arm/Group Description:

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Drug Exposure, as Assessed by Steady State PK
Hide Description Associations between drug exposure and response/survival and toxicity by quartiles of drug exposure.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to funding issues, data were not completed.
Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Hide Arm/Group Description:

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Phase 1: Cycle 1 Day 15, Day 1 of Each Cycle After Cycle 1, Cycle 3 Day 1 (for phase 1 only), and to the End of Treatment. Phase II: From start of treatment until end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Hide Arm/Group Description

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

Patients receive tivozanib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

Tivozanib: Given PO

All-Cause Mortality
Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   18/24 (75.00%)      3/3 (100.00%)    
Hide Serious Adverse Events
Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/24 (62.50%)      3/3 (100.00%)    
Cardiac disorders     
Acute myocardial infarction   1/24 (4.17%)  1 0/3 (0.00%)  0
Cardiac failure congestive   1/24 (4.17%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain upper   1/24 (4.17%)  1 0/3 (0.00%)  0
Colitis   1/24 (4.17%)  1 0/3 (0.00%)  0
Gastrointestinal haemorrhage   1/24 (4.17%)  1 0/3 (0.00%)  0
Oesophageal ulcer haemorrhage   1/24 (4.17%)  1 0/3 (0.00%)  0
Pancreatitis   1/24 (4.17%)  1 0/3 (0.00%)  0
Stomatitis   0/24 (0.00%)  0 1/3 (33.33%)  1
General disorders     
Pyrexia   1/24 (4.17%)  1 1/3 (33.33%)  1
Hepatobiliary disorders     
Cholecystitis   1/24 (4.17%)  1 0/3 (0.00%)  0
Hepatic failure   2/24 (8.33%)  2 0/3 (0.00%)  0
Infections and infestations     
Bacteraemia   0/24 (0.00%)  0 1/3 (33.33%)  1
Enterocolitis infectious   1/24 (4.17%)  1 0/3 (0.00%)  0
Infection   1/24 (4.17%)  1 0/3 (0.00%)  0
Pneumonia   0/24 (0.00%)  0 1/3 (33.33%)  1
Staphylococcal infection   1/24 (4.17%)  1 0/3 (0.00%)  0
Investigations     
Blood bilirubin increased   2/24 (8.33%)  2 0/3 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration   1/24 (4.17%)  1 0/3 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm malignant   1/24 (4.17%)  1 0/3 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident   1/24 (4.17%)  1 0/3 (0.00%)  0
Encephalopathy   1/24 (4.17%)  2 0/3 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury   1/24 (4.17%)  2 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism   2/24 (8.33%)  2 0/3 (0.00%)  0
Vascular disorders     
Hypertension   1/24 (4.17%)  1 1/3 (33.33%)  1
Hypotension   1/24 (4.17%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Tivozanib 1mg) Treatment (Tivozanib 1.5mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/24 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Increased tendency to bruise   1/24 (4.17%)  1 0/3 (0.00%)  0
Cardiac disorders     
Palpitations   1/24 (4.17%)  1 0/3 (0.00%)  0
Ear and labyrinth disorders     
Hypoacusis   1/24 (4.17%)  1 0/3 (0.00%)  0
Endocrine disorders     
Hypothyroidism   1/24 (4.17%)  1 0/3 (0.00%)  0
Eye disorders     
Vision blurred   0/24 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders     
Abdominal distension   3/24 (12.50%)  3 0/3 (0.00%)  0
Abdominal pain   7/24 (29.17%)  7 2/3 (66.67%)  2
Abdominal pain upper   4/24 (16.67%)  4 0/3 (0.00%)  0
Ascites   1/24 (4.17%)  1 0/3 (0.00%)  0
Constipation   6/24 (25.00%)  7 0/3 (0.00%)  0
Diarrhoea   14/24 (58.33%)  27 2/3 (66.67%)  7
Dyspepsia   1/24 (4.17%)  1 0/3 (0.00%)  0
Faeces discoloured   1/24 (4.17%)  1 0/3 (0.00%)  0
Flatulence   2/24 (8.33%)  2 0/3 (0.00%)  0
Gastrooesophageal reflux disease   3/24 (12.50%)  3 2/3 (66.67%)  2
Large intestinal haemorrhage   1/24 (4.17%)  1 0/3 (0.00%)  0
Lip swelling   1/24 (4.17%)  1 0/3 (0.00%)  0
Nausea   11/24 (45.83%)  23 1/3 (33.33%)  1
Rectal haemorrhage   1/24 (4.17%)  1 0/3 (0.00%)  0
Stomatitis   5/24 (20.83%)  12 1/3 (33.33%)  4
Varices oesophageal   1/24 (4.17%)  1 0/3 (0.00%)  0
Vomiting   9/24 (37.50%)  17 1/3 (33.33%)  1
General disorders     
Chest pain   1/24 (4.17%)  1 1/3 (33.33%)  1
Chills   1/24 (4.17%)  1 0/3 (0.00%)  0
Fatigue   19/24 (79.17%)  45 2/3 (66.67%)  3
Infusion site extravasation   1/24 (4.17%)  1 0/3 (0.00%)  0
Oedema   2/24 (8.33%)  2 0/3 (0.00%)  0
Oedema peripheral   5/24 (20.83%)  5 0/3 (0.00%)  0
Pain   1/24 (4.17%)  1 0/3 (0.00%)  0
Pyrexia   1/24 (4.17%)  1 0/3 (0.00%)  0
Thirst   1/24 (4.17%)  1 0/3 (0.00%)  0
Hepatobiliary disorders     
Cholangitis   1/24 (4.17%)  1 0/3 (0.00%)  0
Hepatic failure   1/24 (4.17%)  1 0/3 (0.00%)  0
Jaundice   1/24 (4.17%)  1 0/3 (0.00%)  0
Portal vein thrombosis   1/24 (4.17%)  1 0/3 (0.00%)  0
Immune system disorders     
Hypersensitivity   1/24 (4.17%)  1 0/3 (0.00%)  0
Infections and infestations     
Bronchitis   1/24 (4.17%)  1 0/3 (0.00%)  0
Candida infection   2/24 (8.33%)  2 0/3 (0.00%)  0
Cellulitis   2/24 (8.33%)  2 0/3 (0.00%)  0
Fungal skin infection   1/24 (4.17%)  1 0/3 (0.00%)  0
Nasopharyngitis   1/24 (4.17%)  1 0/3 (0.00%)  0
Oral candidiasis   1/24 (4.17%)  1 0/3 (0.00%)  0
Perichondritis   1/24 (4.17%)  1 0/3 (0.00%)  0
Pneumonia   1/24 (4.17%)  1 0/3 (0.00%)  0
Rhinitis   2/24 (8.33%)  2 0/3 (0.00%)  0
Sinusitis   1/24 (4.17%)  1 0/3 (0.00%)  0
Urinary tract infection   1/24 (4.17%)  1 0/3 (0.00%)  0
Viral infection   1/24 (4.17%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion   2/24 (8.33%)  2 1/3 (33.33%)  1
Fall   2/24 (8.33%)  2 0/3 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged   0/24 (0.00%)  0 1/3 (33.33%)  1
Alanine aminotransferase increased   6/24 (25.00%)  7 2/3 (66.67%)  2
Ammonia increased   1/24 (4.17%)  1 0/3 (0.00%)  0
Aspartate aminotransferase increased   5/24 (20.83%)  6 2/3 (66.67%)  5
Blood alkaline phosphatase increased   5/24 (20.83%)  8 2/3 (66.67%)  2
Blood bilirubin decreased   1/24 (4.17%)  1 0/3 (0.00%)  0
Blood bilirubin increased   6/24 (25.00%)  14 3/3 (100.00%)  6
Blood creatinine increased   0/24 (0.00%)  0 2/3 (66.67%)  2
Haemoglobin decreased   2/24 (8.33%)  2 1/3 (33.33%)  1
Lipase increased   1/24 (4.17%)  2 0/3 (0.00%)  0
Lymphocyte count decreased   3/24 (12.50%)  4 3/3 (100.00%)  8
Platelet count decreased   4/24 (16.67%)  5 2/3 (66.67%)  3
Urine viscosity increased   1/24 (4.17%)  1 0/3 (0.00%)  0
Weight decreased   8/24 (33.33%)  10 0/3 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia   1/24 (4.17%)  1 0/3 (0.00%)  0
Decreased appetite   15/24 (62.50%)  28 1/3 (33.33%)  1
Dehydration   4/24 (16.67%)  4 2/3 (66.67%)  3
Hypercalcaemia   1/24 (4.17%)  1 0/3 (0.00%)  0
Hyperkalaemia   2/24 (8.33%)  2 3/3 (100.00%)  4
Hypernatraemia   0/24 (0.00%)  0 2/3 (66.67%)  2
Hypoalbuminaemia   4/24 (16.67%)  7 3/3 (100.00%)  5
Hypoglycaemia   2/24 (8.33%)  2 0/3 (0.00%)  0
Hypokalaemia   2/24 (8.33%)  2 0/3 (0.00%)  0
Hypomagnesaemia   1/24 (4.17%)  1 1/3 (33.33%)  1
Hyponatraemia   1/24 (4.17%)  1 2/3 (66.67%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia   3/24 (12.50%)  4 0/3 (0.00%)  0
Back pain   3/24 (12.50%)  3 0/3 (0.00%)  0
Flank pain   3/24 (12.50%)  4 0/3 (0.00%)  0
Groin pain   1/24 (4.17%)  1 0/3 (0.00%)  0
Muscle spasms   2/24 (8.33%)  3 1/3 (33.33%)  1
Muscular weakness   3/24 (12.50%)  4 0/3 (0.00%)  0
Musculoskeletal pain   4/24 (16.67%)  5 0/3 (0.00%)  0
Myalgia   2/24 (8.33%)  3 0/3 (0.00%)  0
Neck pain   1/24 (4.17%)  1 0/3 (0.00%)  0
Pain in extremity   2/24 (8.33%)  2 0/3 (0.00%)  0
Spinal pain   1/24 (4.17%)  1 0/3 (0.00%)  0
Spinal stenosis   1/24 (4.17%)  1 0/3 (0.00%)  0
Nervous system disorders     
Amnesia   1/24 (4.17%)  1 0/3 (0.00%)  0
Balance disorder   1/24 (4.17%)  1 0/3 (0.00%)  0
Cognitive disorder   1/24 (4.17%)  1 0/3 (0.00%)  0
Dizziness   10/24 (41.67%)  12 1/3 (33.33%)  1
Dysgeusia   1/24 (4.17%)  1 0/3 (0.00%)  0
Encephalopathy   4/24 (16.67%)  5 0/3 (0.00%)  0
Headache   5/24 (20.83%)  6 1/3 (33.33%)  1
Hepatic encephalopathy   1/24 (4.17%)  1 0/3 (0.00%)  0
Posterior reversible encephalopathy syndrome   0/24 (0.00%)  0 1/3 (33.33%)  1
Somnolence   2/24 (8.33%)  2 0/3 (0.00%)  0
Taste disorder   2/24 (8.33%)  2 0/3 (0.00%)  0
Psychiatric disorders     
Anxiety   1/24 (4.17%)  1 0/3 (0.00%)  0
Confusional state   2/24 (8.33%)  3 0/3 (0.00%)  0
Delirium   1/24 (4.17%)  1 0/3 (0.00%)  0
Depressed mood   1/24 (4.17%)  1 0/3 (0.00%)  0
Depression   2/24 (8.33%)  2 0/3 (0.00%)  0
Disorientation   1/24 (4.17%)  1 0/3 (0.00%)  0
Insomnia   3/24 (12.50%)  3 0/3 (0.00%)  0
Nightmare   1/24 (4.17%)  1 0/3 (0.00%)  0
Renal and urinary disorders     
Haematuria   2/24 (8.33%)  3 0/3 (0.00%)  0
Nephrolithiasis   1/24 (4.17%)  1 0/3 (0.00%)  0
Pollakiuria   1/24 (4.17%)  1 0/3 (0.00%)  0
Proteinuria   1/24 (4.17%)  1 0/3 (0.00%)  0
Renal disorder   1/24 (4.17%)  1 0/3 (0.00%)  0
Renal failure   0/24 (0.00%)  0 1/3 (33.33%)  1
Urinary incontinence   1/24 (4.17%)  1 0/3 (0.00%)  0
Urinary retention   0/24 (0.00%)  0 1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders     
Cough   4/24 (16.67%)  7 1/3 (33.33%)  1
Dysphonia   8/24 (33.33%)  13 2/3 (66.67%)  4
Dyspnoea   5/24 (20.83%)  6 2/3 (66.67%)  2
Epistaxis   3/24 (12.50%)  4 1/3 (33.33%)  1
Hiccups   1/24 (4.17%)  1 0/3 (0.00%)  0
Nasal congestion   3/24 (12.50%)  4 0/3 (0.00%)  0
Oropharyngeal pain   1/24 (4.17%)  3 0/3 (0.00%)  0
Productive cough   2/24 (8.33%)  3 0/3 (0.00%)  0
Pulmonary embolism   2/24 (8.33%)  2 0/3 (0.00%)  0
Upper respiratory tract congestion   1/24 (4.17%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin   5/24 (20.83%)  5 0/3 (0.00%)  0
Erythema   2/24 (8.33%)  2 0/3 (0.00%)  0
Nail discolouration   1/24 (4.17%)  1 0/3 (0.00%)  0
Nail ridging   1/24 (4.17%)  1 0/3 (0.00%)  0
Night sweats   0/24 (0.00%)  0 1/3 (33.33%)  1
Palmar-plantar erythrodysaesthesia syndrome   3/24 (12.50%)  6 1/3 (33.33%)  1
Pruritus   4/24 (16.67%)  7 0/3 (0.00%)  0
Rash   2/24 (8.33%)  2 1/3 (33.33%)  1
Rash generalised   1/24 (4.17%)  1 0/3 (0.00%)  0
Rash papular   2/24 (8.33%)  4 0/3 (0.00%)  0
Skin discolouration   1/24 (4.17%)  1 0/3 (0.00%)  0
Skin exfoliation   1/24 (4.17%)  1 0/3 (0.00%)  0
Skin hyperpigmentation   1/24 (4.17%)  1 0/3 (0.00%)  0
Skin necrosis   1/24 (4.17%)  2 0/3 (0.00%)  0
Urticaria   1/24 (4.17%)  1 0/3 (0.00%)  0
Vascular disorders     
Hot flush   1/24 (4.17%)  1 0/3 (0.00%)  0
Hypertension   4/24 (16.67%)  5 1/3 (33.33%)  2
Hypotension   2/24 (8.33%)  2 0/3 (0.00%)  0
Pelvic venous thrombosis   1/24 (4.17%)  1 0/3 (0.00%)  0
Peripheral coldness   1/24 (4.17%)  1 0/3 (0.00%)  0
Thrombophlebitis   1/24 (4.17%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Katy Wang, Statistician, M.A.
Organization: Roswell Park Cancer Institute
Phone: 716-845-1300 ext 6269
EMail: katy.wang@roswellpark.org
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01835223    
Other Study ID Numbers: I 229112
NCI-2013-00756 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 229112 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Submitted: April 15, 2013
First Posted: April 18, 2013
Results First Submitted: June 5, 2020
Results First Posted: October 28, 2020
Last Update Posted: October 28, 2020