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Phase II Study of 5-FU, Oxaliplatin Plus Dasatinib in Metastatic Pancreatic Adenocarcinoma (FOLFOX-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01652976
Recruitment Status : Active, not recruiting
First Posted : July 30, 2012
Results First Posted : June 13, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer Metastatic
Interventions Drug: Dasatinib
Drug: mFOLFOX6
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dasatinib and mFOLFOX6
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Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Period Title: Overall Study
Started 44
Completed 44
Not Completed 0
Arm/Group Title Treatment Arm
Hide Arm/Group Description

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
65
(29 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
15
  34.1%
Male
29
  65.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   9.1%
White
38
  86.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
 100.0%
ECOG Performance status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Status = 0
22
  50.0%
Status = 1
19
  43.2%
Status = 2
2
   4.5%
Performance Status Unknown
1
   2.3%
[1]
Measure Description:

ECOG performance status describes a patient's level of functioning in terms of daily activity level and how capable they are of self-care on a scale of 0 (best)-5 (worst). The meaning of each performance status grade reported at baseline is below:

0 = Normal activity

  1. = Fully active, able to carry on all pre-disease performance without restriction; Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature
  2. = In bed < 50% of the time; ambulatory and capable of all self-care, but unable to carry out any work activities
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Determine activity of 5-Fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus dasatinib on progression free survival (PFS) in patients with metastatic pancreatic adenocarcinoma
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: months
4
(2.3 to 8.5)
2.Secondary Outcome
Title Response Rate
Hide Description To determine the response rate (RR) by RECIST 1.1 criteria. The response rate is the number of subjects who had either a complete or partial response by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). The imaging modality used for all RECIST assessments in this study was CT.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
25
(13.19 to 40.34)
3.Secondary Outcome
Title Freedom From Metastasis
Hide Description To determine the rate of freedom from metastasis (FFM), which is defined as the percentage of subjects with documented progressive disease (by RECIST 1.1 criteria) who had no new lesions. RECIST 1.1 criteria defines progressive disease as the appearance of one or more new lesions and/or the increase of the sum of the largest diameter of the target lesions by at least 20% from the smallest sum collected (the sum must also have increased by at least 5 mm).
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed for this outcome measure only includes the 29 participants who had documented disease progression (by RECIST 1.1 criteria) during study participation.
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
65.5
(45.7 to 82.1)
4.Secondary Outcome
Title Median Time To Progression
Hide Description To determine the median time to progression (TTP). TTP is defined as the time (in months) from when a subject achieves either a complete or partial response by RECIST 1.1 criteria until progressive disease (by RECIST 1.1 criteria) or death occurs.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed for this outcome measure includes only the 11 participants who achieved either a complete or partial response by RECIST 1.1 criteria during study participation.
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 11
Median (90% Confidence Interval)
Unit of Measure: months
9.8
(8.6 to 19.5)
5.Secondary Outcome
Title Median Overall Survival
Hide Description To determine median overall survival (OS) in months
Time Frame 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: months
10.6
(6.9 to 12.7)
6.Secondary Outcome
Title Clinical Benefit Rate
Hide Description To determine the clinical benefit rate (CBR). The CBR is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
56.82
(41.03 to 71.65)
7.Secondary Outcome
Title Site of Failure
Hide Description To determine the site of failure of this regimen in this population. The site of failure is the anatomical site(s) where disease progression by RECIST 1.1 criteria was noted on imaging.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Measure Type: Count of Participants
Unit of Measure: Participants
Left pleural effusion
1
   2.3%
Liver
12
  27.3%
Lungs
3
   6.8%
Pancreas/liver
4
   9.1%
Peritoneal carcinomatosis
1
   2.3%
peritoneal carcinomatosis/liver
1
   2.3%
Spleen/liver
1
   2.3%
8.Secondary Outcome
Title Safety and Tolerability
Hide Description To determine the safety profile and tolerability of this regimen in this population by evaluating acute treatment related toxicities using CTCAE v4.0 criteria. Using the CTCAE v4.0, the severity of each adverse event reported was graded on a scale of 1 (mild severity) to 5 (fatal). For this outcome measure the percentage of subjects experiencing any adverse event of each CTCAE grade was tabulated.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of subjects
Percent of subjects experiencing a Grade 1 event 88.6
Percent of subjects experiencing a grade 2 event 90.9
Percent of subjects experiencing a Grade 3 event 86.4
Percent of subjects experiencing a Grade 4 event 22.7
Percent of subjects experiencing a grade 5 event 9.1
9.Secondary Outcome
Title Drug Compliance
Hide Description To determine patient compliance with oral therapy. For this outcome measure, compliance with oral therapy is defined as the percentage of subjects that took dasatinib for at least one cycle. Compliance with oral therapy was documented with a medication diary that subjects were asked to complete to document whether each dose of dasatinib was taken.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
93.2
(81.3 to 98.6)
10.Secondary Outcome
Title Quality of Life, as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ), 2007
Hide Description To determine the quality of life (QOL) of patients receiving this therapy using the CTSQ questionnaire. The CTSQ consists of 16 questions where subjects respond with a score on a scale of 0 (worst)-4 (best). The responses to the questions are used to calculate 3 subscores: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Each subscore is calculated by multiplying the mean response value for the questions used to calculate that subscore by 25. The maximum value is 100 and the minimum value is 0 for all 3 subscores. A higher subscore indicates better QOL in that area. The mean difference in each of the 3 subscores from baseline and 95% confidence interval for the entire study population is reported here. A negative mean difference indicates a decrease from baseline in QOL for that area.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Subscore difference for ET
-8.4
(-16.5 to -0.4)
Subscore difference for FSE
2.1
(-8.1 to 12.3)
Subscore difference for SWT
-0.5
(-8.8 to 7.8)
11.Secondary Outcome
Title Correlative Specimen Analysis
Hide Description Exploratory tissue and serum correlative analyses to identify predictors of response
Time Frame 3 years
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0)
Hide Description The FACT-Hep consists of 45 questions where subjects respond with a score on a scale of 0 (worst)-4 (best). The responses to the questions are summed to calculate 5 subscores: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The mean difference in each of the 5 subscores from baseline, as well as the total score of the 5 subscores (the FACT-Hep Total Score) for the entire study population is reported here. The mean difference in the FACT-G Total Score (calculated by summing the PWB, SWB, EWB, and FWB subscores) is also reported here. A negative mean difference indicates a decrease from baseline in QOL. Score ranges- PWB subscore: 0-28, SWB subscore: 0-28, EWB subscore: 0-24, FWB subscore: 0-28, HCS subscore: 0-72, FACT-G Total Score: 0-108, and FACT-Hep Total Score: 0-180. A higher value for each subscore or total score indicates better QOL.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dasatinib and mFOLFOX6
Hide Arm/Group Description:

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

Overall Number of Participants Analyzed 44
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Subscore difference for PWB
-4.4
(-6.7 to -2.1)
Subscore difference for SWB
-0.9
(-2.5 to 0.8)
Subscore difference for EWB
0.6
(-1.1 to 2.3)
Subscore difference for FWB
-2.8
(-4.6 to -1.0)
Subscore difference for HCS
-6.3
(-9.3 to -3.4)
Difference in FACT-G Total Score
-7.4
(-11.9 to -2.9)
Difference in FACT-Hep Total Score
-13.7
(-20.0 to -7.4)
Time Frame Adverse event data were collected from the time that informed consent was signed until 30 days after the last dose of study treatment. During this time frame, adverse event data was collected at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. The time over which adverse event data was collected for the subjects ranged from 8 days to 44 months, an average of 8.5 months.
Adverse Event Reporting Description Adverse events were assessed by the principal investigator, the treating sub-investigator, and/or the study coordinator at the time informed consent was signed, on day 1 of each treatment cycle, and 30 days after the last dose of study treatment at a minimum. Adverse events were assessed by physical examination, labs, and subject self-reports.
 
Arm/Group Title Treatment Arm
Hide Arm/Group Description

Dasatinib and mFOLFOX6

Dasatinib: Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle

mFOLFOX6: mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle

All-Cause Mortality
Treatment Arm
Affected / at Risk (%)
Total   42/44 (95.45%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm
Affected / at Risk (%)
Total   24/44 (54.55%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  2/44 (4.55%) 
Cardiac disorders   
Atrial fibrillation  1  1/44 (2.27%) 
Gastrointestinal disorders   
Gastritis  1  1/44 (2.27%) 
Abdominal pain  1  2/44 (4.55%) 
Gastrointestinal disorders, other (gastrointestinal hemorrhage-unknown site)  1  1/44 (2.27%) 
Abdominal infection  1  1/44 (2.27%) 
Diarrhea  1  1/44 (2.27%) 
Nausea  1  3/44 (6.82%) 
Vomiting  1  3/44 (6.82%) 
Small intestinal obstruction  1  1/44 (2.27%) 
Ascites  1  1/44 (2.27%) 
Lower gastrointestinal hemorrhage  1  1/44 (2.27%) 
Cholangitis  1  1/44 (2.27%) 
Colitis  1  1/44 (2.27%) 
Esophageal infection  1  1/44 (2.27%) 
Oral Mucositis  1  1/44 (2.27%) 
General disorders   
Non-cardiac chest pain  1  1/44 (2.27%) 
Fever  1  1/44 (2.27%) 
Flu-like symptoms  1  1/44 (2.27%) 
Edema trunk  1  1/44 (2.27%) 
Infections and infestations   
Sepsis  1  1/44 (2.27%) 
Injury, poisoning and procedural complications   
Wound dehiscense  1  1/44 (2.27%) 
Investigations   
Blood bilirubin increased  1  1/44 (2.27%) 
Metabolism and nutrition disorders   
Hypercalcemia  1  1/44 (2.27%) 
Dehydration  1  1/44 (2.27%) 
Nervous system disorders   
Nervous system disorders, other (Stroke-like symptoms)  1  1/44 (2.27%) 
Subdural hematoma  1  1/44 (2.27%) 
Renal and urinary disorders   
Renal and urinary disorders, other (kidney stone)  1  1/44 (2.27%) 
Acute renal injury  1  1/44 (2.27%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  4/44 (9.09%) 
Upper respiratory infection  1  1/44 (2.27%) 
Respiratory failure  1  1/44 (2.27%) 
Respiratory, thoracic, and mediastinal disorders, other (pneumonia)  1  1/44 (2.27%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm
Affected / at Risk (%)
Total   44/44 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  9/44 (20.45%) 
Gastrointestinal disorders   
Vomiting  1  26/44 (59.09%) 
Oral Pain  1  5/44 (11.36%) 
Nausea  1  31/44 (70.45%) 
Mucositis oral  1  17/44 (38.64%) 
Hemorrhoids  1  3/44 (6.82%) 
Gastroesophageal reflux disease  1  3/44 (6.82%) 
Diarrhea  1  24/44 (54.55%) 
Constipation  1  19/44 (43.18%) 
Bloating  1  4/44 (9.09%) 
Ascites  1  5/44 (11.36%) 
Abdominal distension  1  4/44 (9.09%) 
Abdominal pain  1  18/44 (40.91%) 
General disorders   
Pain  1  3/44 (6.82%) 
Localized edema  1  3/44 (6.82%) 
General disorders and administrative site conditions - other  1 [1]  3/44 (6.82%) 
Flu-like symtoms  1  4/44 (9.09%) 
Fever  1  11/44 (25.00%) 
Fatigue  1  32/44 (72.73%) 
Edema limbs  1  7/44 (15.91%) 
Chills  1  5/44 (11.36%) 
Infections and infestations   
Upper respiratory tract infection  1  7/44 (15.91%) 
Injury, poisoning and procedural complications   
Fall  1  3/44 (6.82%) 
Investigations   
Weight Loss  1  11/44 (25.00%) 
Platelet count decreased  1  8/44 (18.18%) 
Neutrophil count decreased  1  15/44 (34.09%) 
Metabolism and nutrition disorders   
Hyponatremia  1  4/44 (9.09%) 
Hypokalemia  1  4/44 (9.09%) 
Dehydration  1  4/44 (9.09%) 
Anorexia  1  21/44 (47.73%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  3/44 (6.82%) 
Back Pain  1  5/44 (11.36%) 
Nervous system disorders   
Peripheral sensory Neuropathy  1  30/44 (68.18%) 
Parasthesia  1  3/44 (6.82%) 
Headache  1  6/44 (13.64%) 
Dysgeusia  1  12/44 (27.27%) 
Dysethesia  1  3/44 (6.82%) 
Dizziness  1  7/44 (15.91%) 
Psychiatric disorders   
Insomnia  1  8/44 (18.18%) 
Depression  1  4/44 (9.09%) 
Anxiety  1  9/44 (20.45%) 
Renal and urinary disorders   
Urinary frequency  1  4/44 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Sore throat  1  3/44 (6.82%) 
Pleural effusion  1  9/44 (20.45%) 
Hiccups  1  4/44 (9.09%) 
Epistaxis  1  4/44 (9.09%) 
Dyspnea  1  9/44 (20.45%) 
Cough  1  3/44 (6.82%) 
Skin and subcutaneous tissue disorders   
Skin and subcutaneous disorders, other  1  5/44 (11.36%) 
Rash maculo-papular  1  7/44 (15.91%) 
Periorbital edema  1  6/44 (13.64%) 
Palmar-plantar erythrodysesthesia syndrome  1  3/44 (6.82%) 
Vascular disorders   
Hypertension  1  4/44 (9.09%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Night sweats
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: Allison Allegra
Organization: University of Florida
Phone: 352-294-5691
EMail: allisonallegra3@ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01652976     History of Changes
Other Study ID Numbers: IRB201600540
CA180-359 ( Other Identifier: University of Florida )
OCR11303 ( Other Identifier: OnCore )
First Submitted: July 23, 2012
First Posted: July 30, 2012
Results First Submitted: March 1, 2019
Results First Posted: June 13, 2019
Last Update Posted: October 18, 2019