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Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT01266031
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : September 23, 2016
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Genentech, Inc.
Merck Sharp & Dohme Corp.
Brain Tumor Trials Collaborative
Ohio State University Wexner Medical Center
Northwestern University Feinberg School of Medicine
UF Health Cancer Center at Orlando Health
Baylor Health Care System
MUSC Hollings Cancer Center
University of Utah Health System
University of Washington
Henry Ford Health System
Columbia University
Rush University Medical Center
NorthShore University HealthSystem
The Cleveland Clinic
University of North Carolina, Chapel Hill
Washington University School of Medicine
Texas Oncology-Austin
Information provided by (Responsible Party):
Mark Gilbert, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Malignant Glioma
Recurrent Glioblastoma
Interventions Drug: vorinostat
Drug: bevacizumab
Enrollment 96
Recruitment Details Recruitment Period: the study was initially written in 2010 and eventually activated at the lead site on 7/6/2011.
Pre-assignment Details  
Arm/Group Title Vorinostat + Bevacizumab Bevacizumab Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle. Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle. Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Period Title: Overall Study
Started 6 41 49
Completed 6 38 47
Not Completed 0 3 2
Reason Not Completed
Not treated             0             3             2
Arm/Group Title Vorinostat + Bevacizumab Bevacizumab Bevacizumab + Vorinostat 400 mg Total
Hide Arm/Group Description Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle. Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle. Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle. Total of all reporting groups
Overall Number of Baseline Participants 6 41 49 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 41 participants 49 participants 96 participants
51.5
(18 to 66)
60
(27 to 88)
57
(22 to 75)
57
(18 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 41 participants 49 participants 96 participants
Female
3
  50.0%
12
  29.3%
18
  36.7%
33
  34.4%
Male
3
  50.0%
29
  70.7%
31
  63.3%
63
  65.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 41 participants 49 participants 96 participants
6 41 49 96
1.Primary Outcome
Title Progression Free Survival (PFS) at 6 Months
Hide Description

PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year.

Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial.

Study outcome measure period ended June 2015.

Time Frame Baseline until disease progression or death due to any cause, up to six months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description:
Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Overall Number of Participants Analyzed 38 47
Median (95% Confidence Interval)
Unit of Measure: Months
0.29
(0.15 to 0.45)
0.23
(0.12 to 0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab, Bevacizumab + Vorinostat 400 mg
Comments Null hypothesis is: progression free survival (PFS) 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments Null hypothesis is: PFS 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab
Hide Description MTD defined as the dose level at which 1/6 patients experience dose limiting toxicity (DLT), using conventional Phase I design where the MTD was selected using a 3+3 accrual design at each dose level until MTD was determined. Toxicities will be graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0.
Time Frame 28 day, cycle 1
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vorinostat + Bevacizumab
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Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: mg/day
400
3.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Progression defined by the Modified MacDonald criteria is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame 3, 6, and 12 months from patient registration
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II: Bevacizumab Phase II: Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description:
Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Overall Number of Participants Analyzed 38 47
Median (95% Confidence Interval)
Unit of Measure: Months
Overall TTP
4.07
(1.94 to 5.88)
3.71
(2.73 to 4.63)
3 months
0.59
(0.41 to 0.73)
0.62
(0.46 to 0.74)
6 months
0.29
(0.15 to 0.45)
0.28
(0.15 to 0.42)
12 months
0.06
(0.01 to 0.19)
0.15
(0.06 to 0.29)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was computed using the number of months from the date of randomization to the date of death, up to 30 months. Participants still alive were censored at the last follow-up date.
Time Frame up to 30 months.
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description:
Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Overall Number of Participants Analyzed 38 47
Median (95% Confidence Interval)
Unit of Measure: Months
9.24
(5.88 to 11.40)
7.80
(5.04 to 9.12)
5.Secondary Outcome
Title Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Vascular Endothelial Growth Factor (VEGF), Placental Growth Factor (PIGF), and Basic Fibroblast Growth Factor (bFGF)
Hide Description About 5cc of blood was collected to measure plasma angiogenic proteins vascular endothelial growth factor (VEGF), placental growth factor (PIGF), and basic fibroblast growth factor (bFGF) by enzyme-linked immunosorbent assay (ELISA).
Time Frame Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)
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Hide Analysis Population Description
This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study.
Arm/Group Title Phase I: Vorinostat + Bevacizumab Phase II: Bevacizumab Phase II: Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description:
Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Effects of Bevacizumab With and Without Vorinostat Upon Biomarkers of Angiogenesis Stromal Cell-derived Factor α (SDF1α), and Angiopoietin 1 (Ang 1) and 2 (Ang 2) by Enzyme-linked Immunosorbent Assay (ELISA)
Hide Description About 5cc of blood was collected to measure plasma angiogenic proteins stromal cell-derived factor α (SDF1α), angiopoietin 1 and 2 by enzyme-linked immunosorbent assay (ELISA).
Time Frame Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study.
Arm/Group Title Vorinostat + Bevacizumab Bevacizumab Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description:
Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool
Hide Description Percentage of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is "not present" and 10 is "as bad as you can imagine. All patients with at least one valid questionnaire will be included in the analyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures.
Time Frame Baseline, week 4, week 8, and end of therapy, approximately week 52 (cycle 12)
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Hide Analysis Population Description
Reason outcome measure #7 is not done per arm/group is it was intentionally not completed due to negative findings of the study’s primary outcomes.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants who received at least one dose of Bevacizumab by vein and/or Bevacizumab (by vein) + Vorinostat by mouth of a 28 day cycle.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of of participants
Baseline Number Analyzed 50 participants
2
Cycle 2, week 4 Number Analyzed 31 participants
0
Cycle 4, week 8 Number Analyzed 21 participants
0
End ot therapy, week 52 Number Analyzed 28 participants
0
8.Secondary Outcome
Title Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool
Hide Description Overall mean severity of 22 symptoms. Symptoms are rated 0-10, zero is “not present” and 10 is “as bad as you can imagine”. All patients with at least one valid questionnaire will be included in the analyses.
Time Frame Baseline, week 4 (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall analysis was done but not done by treatment arm/group.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants who received at least one dose of Bevacizumab by vein and/or Bevacizumab (by vein) + Vorinostat by mouth of a 28 day cycle.
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 50 participants
1.6  (1.5)
Cycle 2 Number Analyzed 31 participants
1.3  (1.1)
Cycle 4 Number Analyzed 21 participants
1.9  (1.6)
End of therapy Number Analyzed 28 participants
2.2  (1.7)
9.Secondary Outcome
Title Mean Symptom Interference at the Time of Clinical Evaluation
Hide Description Overall mean interference severity of 6 interference items. Interference is rated 0-10, zero is “did not interfere” and 10 is “as bad as you can imagine”. All patients with at least one valid questionnaire will be included in the analyses.
Time Frame Baseline, (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall analysis was done but not done by treatment arm/group.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants who received at least one dose of Bevacizumab by vein and/or Bevacizumab (by vein) + Vorinostat by mouth of a 28 day cycle.
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 50 participants
2.2  (2.4)
Cycle 2 Number Analyzed 32 participants
1.7  (1.7)
Cycle 4 Number Analyzed 21 participants
2.9  (2.4)
End of therapy Number Analyzed 29 participants
2.9  (2.6)
10.Secondary Outcome
Title Radiological Response
Hide Description Magnetic resonance imaging (MRI) and contrast-enhanced (CE) MRI was used to evaluate tumor response. Response is defined by the Modified MacDonald criteria. Complete Response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. Partial Response, Non-Measurable (PRNM) is not applicable. Stable/No Response does not qualify for CR, PR or progression. Progression is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).
Time Frame End of therapy, approximately
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done. We collected radiological response data provided by the local physician at time points per protocol. At the end of the study, the plan was to send all MRI discs to one radiologist for central review to confirm responses. With only limited funding, and negative findings, the PI decided to not pursue this outcome.
Arm/Group Title Vorinostat + Bevacizumab Bevacizumab Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description:
Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Number of Participants With Serious and Non-Serious Adverse Events
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vorinostat + Bevacizumab Bevacizumab Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description:
Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
Overall Number of Participants Analyzed 6 38 47
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
38
 100.0%
47
 100.0%
Time Frame Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle.
Adverse Event Reporting Description The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
 
Arm/Group Title Phase I: Vorinostat + Bevacizumab Phase II: Bevacizumab Phase II: Bevacizumab + Vorinostat 400 mg
Hide Arm/Group Description Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle. Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle. Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
All-Cause Mortality
Phase I: Vorinostat + Bevacizumab Phase II: Bevacizumab Phase II: Bevacizumab + Vorinostat 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/38 (0.00%)      1/47 (2.13%)    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: Vorinostat + Bevacizumab Phase II: Bevacizumab Phase II: Bevacizumab + Vorinostat 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      10/38 (26.32%)      14/47 (29.79%)    
Blood and lymphatic system disorders       
Blood and Lymphatic System Disorders, Other, specify  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Cardiac disorders       
Atrial fibrillation  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Gastrointestinal disorders       
Colonic perforation  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Constipation  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Nausea  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Vomiting  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
General disorders       
Death NOS  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Non-cardiac chest pain  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Pain  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Infections and infestations       
Wound infection  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Injury, poisoning and procedural complications       
Wound dehiscence  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Investigations       
Ejection fraction decreased  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/6 (0.00%)  0 2/38 (5.26%)  2 0/47 (0.00%)  0
Hypernatremia  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Nervous system disorders       
Edema cerebral  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Encephalopathy  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Headache  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Intracranial hemorrhage  1  0/6 (0.00%)  0 1/38 (2.63%)  1 2/47 (4.26%)  2
Lethargy  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Seizure  1  0/6 (0.00%)  0 3/38 (7.89%)  3 2/47 (4.26%)  2
Stroke  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Syncope  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Psychiatric disorders       
Cognitive disturbance  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Renal and urinary disorders       
Urinary retention  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Renal and urinary disorders, Other, specify  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders       
Hypoxia  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Infections and infestations  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Upper respiratory infection  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders, Other specify  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Skin and subcutaneous tissue disorders       
Rash maculo-papular  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Vascular disorders       
Hypertension  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Thromboembolic event  1  0/6 (0.00%)  0 0/38 (0.00%)  0 5/47 (10.64%)  5
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 0%
Phase I: Vorinostat + Bevacizumab Phase II: Bevacizumab Phase II: Bevacizumab + Vorinostat 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      36/38 (94.74%)      43/47 (91.49%)    
Blood and lymphatic system disorders       
Anemia  1  0/6 (0.00%)  0 3/38 (7.89%)  6 6/47 (12.77%)  8
Blood and lymphatic system disorders - Other, specify  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  3
Leukocytosis  1  3/6 (50.00%)  10 0/38 (0.00%)  0 0/47 (0.00%)  0
Thrombotic thrombocytopenic purpura  1  0/6 (0.00%)  0 2/38 (5.26%)  2 1/47 (2.13%)  6
Cardiac disorders       
Chest pain - cardiac  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Sinus bradycardia  1  1/6 (16.67%)  1 0/38 (0.00%)  0 1/47 (2.13%)  1
Sinus tachycardia  1  0/6 (0.00%)  0 0/38 (0.00%)  0 4/47 (8.51%)  5
Ear and labyrinth disorders       
Ear and labyrinth disorders, Other, specify  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Middle ear inflammation  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Tinnitus  1  0/6 (0.00%)  0 2/38 (5.26%)  2 0/47 (0.00%)  0
Vertigo  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Endocrine disorders       
Adrenal insufficiency  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Cushingoid  1  1/6 (16.67%)  1 1/38 (2.63%)  1 0/47 (0.00%)  0
Eye disorders       
Blurred vision  1  1/6 (16.67%)  2 2/38 (5.26%)  3 2/47 (4.26%)  2
Conjunctivitis  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Diplopia  1  2/6 (33.33%)  2 0/38 (0.00%)  0 0/47 (0.00%)  0
Dry eye  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Eye disorders - Other, specify  1  0/6 (0.00%)  0 1/38 (2.63%)  1 7/47 (14.89%)  10
OCULAR SURFACE DISEASE  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
OCULAR/VISUAL (Right homonymous hemianopsia)  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
OCULAR/VISUAL (Right & Left visual field deficits)  1  2/6 (33.33%)  2 0/38 (0.00%)  0 0/47 (0.00%)  0
Photophobia  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Gastrointestinal disorders       
Abdominal distension  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Abdominal pain  1  0/6 (0.00%)  0 4/38 (10.53%)  5 2/47 (4.26%)  4
Bloating  1  1/6 (16.67%)  1 1/38 (2.63%)  1 0/47 (0.00%)  0
Constipation  1  4/6 (66.67%)  6 4/38 (10.53%)  4 11/47 (23.40%)  11
Dental caries  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Diarrhea  1  2/6 (33.33%)  3 4/38 (10.53%)  6 9/47 (19.15%)  20
Dry mouth  1  0/6 (0.00%)  0 0/38 (0.00%)  0 3/47 (6.38%)  3
Dyspepsia  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  4
Dysphagia  1  1/6 (16.67%)  1 1/38 (2.63%)  2 2/47 (4.26%)  2
Fecal incontinence  1  0/6 (0.00%)  0 2/38 (5.26%)  2 0/47 (0.00%)  0
Flatulence  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Gastric ulcer  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Gastroesophageal reflux disease  1  0/6 (0.00%)  0 1/38 (2.63%)  1 3/47 (6.38%)  3
Gastrointestinal (sensitivity to smell)  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  0/6 (0.00%)  0 3/38 (7.89%)  4 3/47 (6.38%)  3
Heartburn  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Hemorrhoids  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Mucositis oral  1  1/6 (16.67%)  1 2/38 (5.26%)  3 0/47 (0.00%)  0
Nausea  1  5/6 (83.33%)  8 6/38 (15.79%)  7 16/47 (34.04%)  20
Obstruction GI (STOMACH-small bowel nos)  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Oral hemorrhage  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  2
Oral pain  1  0/6 (0.00%)  0 1/38 (2.63%)  2 1/47 (2.13%)  1
Stomach pain  1  2/6 (33.33%)  3 1/38 (2.63%)  1 0/47 (0.00%)  0
Vomiting  1  1/6 (16.67%)  1 2/38 (5.26%)  2 5/47 (10.64%)  6
General disorders       
Chills  1  0/6 (0.00%)  0 1/38 (2.63%)  2 0/47 (0.00%)  0
Edema face  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Edema limbs  1  3/6 (50.00%)  3 6/38 (15.79%)  8 0/47 (0.00%)  0
Fatigue  1  6/6 (100.00%)  11 10/38 (26.32%)  16 22/47 (46.81%)  31
Fever  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Gait disturbance  1  4/6 (66.67%)  7 5/38 (13.16%)  8 4/47 (8.51%)  5
Gait/walking (wide based ataxic hemiparetic)  1  2/6 (33.33%)  2 0/38 (0.00%)  0 0/47 (0.00%)  0
Gait/walking Impaired mobility  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
General disorders and administration site conditions - Other, specify  1  0/6 (0.00%)  0 2/38 (5.26%)  4 3/47 (6.38%)  6
Infusion related reaction  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Localized edema  1  0/6 (0.00%)  0 3/38 (7.89%)  4 0/47 (0.00%)  0
Malaise  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Non-cardiac chest pain  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Pain  1  0/6 (0.00%)  0 1/38 (2.63%)  2 6/47 (12.77%)  8
Immune system disorders       
Allergic reaction  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  2
Infections and infestations       
Bronchial infection  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Infection with Normal ANC (Neck NOS), cellulitis  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Infection with Normal ANC (Neck NOS), herpes zoster  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Infection with Normal ANC (Neck NOS), (Urinary Tract NOS)  1  3/6 (50.00%)  3 0/38 (0.00%)  0 0/47 (0.00%)  0
Infection with Normal ANC (Wound), Herpes Z-back-perineal-scrutum  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Infections and infestations  1  0/6 (0.00%)  0 6/38 (15.79%)  6 2/47 (4.26%)  2
Mucosal infection  1  0/6 (0.00%)  0 1/38 (2.63%)  2 0/47 (0.00%)  0
Paronychia  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Rhinitis infective  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Sinusitis  1  0/6 (0.00%)  0 1/38 (2.63%)  2 1/47 (2.13%)  1
Tooth infection  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Upper respiratory infection  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Wound infection  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Urinary tract infection  1  1/6 (16.67%)  1 1/38 (2.63%)  1 3/47 (6.38%)  6
Injury, poisoning and procedural complications       
Bruising  1  2/6 (33.33%)  2 4/38 (10.53%)  5 2/47 (4.26%)  4
Burn  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Fall  1  0/6 (0.00%)  0 3/38 (7.89%)  3 5/47 (10.64%)  6
Investigations       
Alanine aminotransferase (ALT) increased  1  2/6 (33.33%)  4 2/38 (5.26%)  3 4/47 (8.51%)  6
Alkaline phosphatase increased  1  2/6 (33.33%)  2 0/38 (0.00%)  0 3/47 (6.38%)  3
Aspartate aminotransferase (AST) increased  1  2/6 (33.33%)  4 1/38 (2.63%)  2 3/47 (6.38%)  4
Blood bilirubin increased  1  1/6 (16.67%)  2 1/38 (2.63%)  1 3/47 (6.38%)  3
Cholesterol high  1  1/6 (16.67%)  1 0/38 (0.00%)  0 2/47 (4.26%)  2
Creatinine increased  1  1/6 (16.67%)  1 4/38 (10.53%)  7 3/47 (6.38%)  5
Flu like symptoms  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Hemoglobin Increase  1  5/6 (83.33%)  9 0/38 (0.00%)  0 0/47 (0.00%)  0
International normalized ratio (INR) increased  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Investigations - Other, specify  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Lymphocyte count decreased  1  5/6 (83.33%)  24 7/38 (18.42%)  8 4/47 (8.51%)  10
Lymphocyte count increased  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Neutrophil count decreased  1  0/6 (0.00%)  0 1/38 (2.63%)  1 8/47 (17.02%)  16
Platelet count decreased  1  5/6 (83.33%)  5 6/38 (15.79%)  9 11/47 (23.40%)  19
Weight gain  1  0/6 (0.00%)  0 2/38 (5.26%)  2 3/47 (6.38%)  4
Weight loss  1  1/6 (16.67%)  1 3/38 (7.89%)  5 6/47 (12.77%)  6
White blood cell decreased  1  0/6 (0.00%)  0 2/38 (5.26%)  2 5/47 (10.64%)  13
Metabolism and nutrition disorders       
Anorexia  1  2/6 (33.33%)  3 5/38 (13.16%)  5 15/47 (31.91%)  17
Bicarbonate Serum-low  1  4/6 (66.67%)  6 0/38 (0.00%)  0 0/47 (0.00%)  0
Dehydration  1  1/6 (16.67%)  1 0/38 (0.00%)  0 2/47 (4.26%)  2
Hyperglycemia  1  2/6 (33.33%)  19 10/38 (26.32%)  17 10/47 (21.28%)  18
Hyperkalemia  1  0/6 (0.00%)  0 1/38 (2.63%)  2 0/47 (0.00%)  0
Hypermagnesemia  1  0/6 (0.00%)  0 1/38 (2.63%)  2 1/47 (2.13%)  2
Hypernatremia  1  0/6 (0.00%)  0 1/38 (2.63%)  1 2/47 (4.26%)  2
Hypertriglycedidemia  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Hyperuricemia  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Hypoalbuminemia  1  3/6 (50.00%)  6 1/38 (2.63%)  1 2/47 (4.26%)  3
Hypocalcemia  1  1/6 (16.67%)  1 3/38 (7.89%)  3 1/47 (2.13%)  1
Hypoglycemia  1  2/6 (33.33%)  2 0/38 (0.00%)  0 3/47 (6.38%)  4
Hypokalemia  1  2/6 (33.33%)  6 4/38 (10.53%)  5 4/47 (8.51%)  4
Hypomagnesemia  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Hyponatremia  1  3/6 (50.00%)  9 4/38 (10.53%)  5 1/47 (2.13%)  1
Hypophosphatemia  1  2/6 (33.33%)  2 0/38 (0.00%)  0 0/47 (0.00%)  0
METABOLIC/LABORATORY (Elevated BUN)  1  3/6 (50.00%)  4 0/38 (0.00%)  0 0/47 (0.00%)  0
METABOLIC/LABORATORY (elevated LDH)  1  3/6 (50.00%)  4 0/38 (0.00%)  0 0/47 (0.00%)  0
METABOLIC/LABORATORY (high chloride)  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
METABOLIC/LABORATORY (low chloride)  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
METABOLIC/LABORATORY (low creatinine)  1  2/6 (33.33%)  3 0/38 (0.00%)  0 0/47 (0.00%)  0
METABOLIC/LABORATORY (low protein)  1  2/6 (33.33%)  3 0/38 (0.00%)  0 0/47 (0.00%)  0
METABOLIC/LABORATORY (low uric acid)  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Arthritis  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Back pain  1  0/6 (0.00%)  0 2/38 (5.26%)  2 2/47 (4.26%)  2
Generalized muscle weakness  1  0/6 (0.00%)  0 2/38 (5.26%)  3 2/47 (4.26%)  2
Joint effusion  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Joint Pain  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Muscle weakness- Whole body/generalized  1  2/6 (33.33%)  2 0/38 (0.00%)  0 0/47 (0.00%)  0
Muscle weakness lower extremity  1  2/6 (33.33%)  2 0/38 (0.00%)  0 0/47 (0.00%)  0
Muscle weakness left-sided  1  0/6 (0.00%)  0 1/38 (2.63%)  4 7/47 (14.89%)  8
Muscle weakness lower limb  1  0/6 (0.00%)  0 2/38 (5.26%)  2 1/47 (2.13%)  1
Muscle weakness right-sided  1  0/6 (0.00%)  0 5/38 (13.16%)  5 2/47 (4.26%)  3
Muscle weakness upper limb  1  0/6 (0.00%)  0 1/38 (2.63%)  1 2/47 (4.26%)  2
Musculoskeletal and connective tissue disorder - Other, specify  1  0/6 (0.00%)  0 0/38 (0.00%)  0 7/47 (14.89%)  10
Myalgia  1  0/6 (0.00%)  0 3/38 (7.89%)  3 2/47 (4.26%)  2
PAIN (BACK)  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Pain (Neuropathic in perineal/buttock)  1  1/6 (16.67%)  3 0/38 (0.00%)  0 0/47 (0.00%)  0
Pain in extremity  1  1/6 (16.67%)  1 2/38 (5.26%)  3 4/47 (8.51%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  2
Nervous system disorders       
Akathisia  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  2
Amnesia  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Ataxia  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Cognitive disturbance  1  0/6 (0.00%)  0 5/38 (13.16%)  6 6/47 (12.77%)  8
Concentration impairment  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Dizziness  1  4/6 (66.67%)  5 3/38 (7.89%)  4 11/47 (23.40%)  11
Dysarthria  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Dysgeusia  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Dysphasia  1  0/6 (0.00%)  0 4/38 (10.53%)  6 2/47 (4.26%)  2
Edema cerebral  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Facial nerve disorder  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Headache  1  6/6 (100.00%)  10 11/38 (28.95%)  14 11/47 (23.40%)  21
Hypersomnia  1  0/6 (0.00%)  0 2/38 (5.26%)  3 1/47 (2.13%)  1
Lethargy  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Memory impairment  1  4/6 (66.67%)  5 10/38 (26.32%)  11 11/47 (23.40%)  13
Movements involuntary  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Nervous system disorders - Other, specify  1  0/6 (0.00%)  0 2/38 (5.26%)  4 11/47 (23.40%)  24
Neuropathy, Numbness, Right sided  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Neuropathy, Cranial (Pupil, Upper eyelid)  1  2/6 (33.33%)  4 0/38 (0.00%)  0 0/47 (0.00%)  0
Neuropathy, Sensory Legs/Toes tingling  1  2/6 (33.33%)  2 0/38 (0.00%)  0 0/47 (0.00%)  0
Nystagmus  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Paresthesia  1  0/6 (0.00%)  0 2/38 (5.26%)  2 5/47 (10.64%)  6
Peripheral sensory neuropathy  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Pyramidal Tract Dysfunction  1  4/6 (66.67%)  8 0/38 (0.00%)  0 0/47 (0.00%)  0
Seizure  1  2/6 (33.33%)  2 5/38 (13.16%)  7 6/47 (12.77%)  7
Sensory loss left side  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Sinus pain  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Somnolence  1  2/6 (33.33%)  2 2/38 (5.26%)  3 1/47 (2.13%)  1
Speech Impairment  1  3/6 (50.00%)  5 0/38 (0.00%)  0 0/47 (0.00%)  0
Stroke  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Taste Alteration  1  2/6 (33.33%)  2 0/38 (0.00%)  0 0/47 (0.00%)  0
Tremor  1  1/6 (16.67%)  1 2/38 (5.26%)  2 1/47 (2.13%)  1
Encephalopathy  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Psychiatric disorders       
Agitation  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  2
Anxiety  1  0/6 (0.00%)  0 2/38 (5.26%)  2 3/47 (6.38%)  3
Confusion  1  2/6 (33.33%)  2 3/38 (7.89%)  5 3/47 (6.38%)  4
Depression  1  0/6 (0.00%)  0 3/38 (7.89%)  4 5/47 (10.64%)  5
Insomnia  1  1/6 (16.67%)  1 3/38 (7.89%)  4 4/47 (8.51%)  4
Mental Status Altered  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Mood Alteration  1  3/6 (50.00%)  3 0/38 (0.00%)  0 0/47 (0.00%)  0
Psychiatric disorders - Other, specify  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Restlessness  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Renal and urinary disorders       
Proteinuria  1  0/6 (0.00%)  0 3/38 (7.89%)  3 0/47 (0.00%)  0
Renal and urinary disorders - Other, specify  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Urinary frequency  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Urinary incontinence  1  0/6 (0.00%)  0 3/38 (7.89%)  4 2/47 (4.26%)  2
Reproductive system and breast disorders       
Irregular Menses  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Reproductive system and breast disorders - Other, specify  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Vaginal discharge  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  1/6 (16.67%)  1 0/38 (0.00%)  0 2/47 (4.26%)  2
Atelectasis  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Cough  1  0/6 (0.00%)  0 7/38 (18.42%)  8 5/47 (10.64%)  6
Dyspnea  1  1/6 (16.67%)  1 2/38 (5.26%)  3 6/47 (12.77%)  6
Epistaxis  1  1/6 (16.67%)  1 3/38 (7.89%)  3 4/47 (8.51%)  4
Hiccups  1  1/6 (16.67%)  2 0/38 (0.00%)  0 1/47 (2.13%)  1
Hoarseness  1  0/6 (0.00%)  0 2/38 (5.26%)  2 4/47 (8.51%)  4
Nasal congestion  1  0/6 (0.00%)  0 4/38 (10.53%)  4 1/47 (2.13%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  0/6 (0.00%)  0 1/38 (2.63%)  1 2/47 (4.26%)  2
Sinus disorder  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
Sneezing  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Sore throat  1  1/6 (16.67%)  1 2/38 (5.26%)  2 4/47 (8.51%)  4
Voice alteration  1  1/6 (16.67%)  1 1/38 (2.63%)  1 0/47 (0.00%)  0
Wheezing  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  0/6 (0.00%)  0 0/38 (0.00%)  0 3/47 (6.38%)  3
DECUBITUS Ulcer Sacrum  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Bump at sutura site  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Multiple scabs  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Dry skin  1  0/6 (0.00%)  0 0/38 (0.00%)  0 2/47 (4.26%)  2
Pain of skin  1  0/6 (0.00%)  0 0/38 (0.00%)  0 1/47 (2.13%)  1
Pruritus  1  1/6 (16.67%)  2 3/38 (7.89%)  4 2/47 (4.26%)  2
Rash acneiform  1  0/6 (0.00%)  0 1/38 (2.63%)  1 4/47 (8.51%)  5
Rash maculo-papular  1  0/6 (0.00%)  0 4/38 (10.53%)  4 1/47 (2.13%)  1
Skin and subcutaneous tissue disorders - Other, specify  1  0/6 (0.00%)  0 4/38 (10.53%)  8 3/47 (6.38%)  4
Skin infection  1  0/6 (0.00%)  0 2/38 (5.26%)  2 2/47 (4.26%)  2
Skin ulceration  1  0/6 (0.00%)  0 2/38 (5.26%)  2 1/47 (2.13%)  1
Telangiectasia  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Hyperpigmentation (hands & knuckles)  1  1/6 (16.67%)  1 0/38 (0.00%)  0 0/47 (0.00%)  0
Vascular disorders       
Hematoma  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Hypertension  1  0/6 (0.00%)  0 19/38 (50.00%)  57 18/47 (38.30%)  41
Hypotension  1  0/6 (0.00%)  0 1/38 (2.63%)  1 0/47 (0.00%)  0
Thromboembolic event  1  0/6 (0.00%)  0 1/38 (2.63%)  1 1/47 (2.13%)  1
1
Term from vocabulary, CTCAE (4.0)
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
Name/Title: Dr. Mark Gilbert
Organization: National Cancer Institute
Phone: 301-402-6383
Responsible Party: Mark Gilbert, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01266031     History of Changes
Other Study ID Numbers: 999916116
16-C-N116
First Submitted: December 22, 2010
First Posted: December 24, 2010
Results First Submitted: March 15, 2016
Results First Posted: September 23, 2016
Last Update Posted: July 31, 2018