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Trial record 32 of 48 for:    Dovitinib

Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma

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: NCT01753713
Recruitment Status : Completed
First Posted : December 20, 2012
Results First Posted : August 8, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Novartis
Information provided by (Responsible Party):
Manmeet Ahluwalia, MD, Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions Drug: dovitinib
Other: laboratory biomarker analysis
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anti-angiogenic Therapy Patients Anti-angiogenic Therapy Naive Patients
Hide Arm/Group Description

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 14 19
Completed 14 19
Not Completed 0 0
Arm/Group Title Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients Total
Hide Arm/Group Description

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 19 14 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 14 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  84.2%
13
  92.9%
29
  87.9%
>=65 years
3
  15.8%
1
   7.1%
4
  12.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants 14 participants 33 participants
58
(33 to 68)
51
(26 to 66)
57
(26 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 14 participants 33 participants
Female
7
  36.8%
5
  35.7%
12
  36.4%
Male
12
  63.2%
9
  64.3%
21
  63.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 14 participants 33 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
19
 100.0%
13
  92.9%
32
  97.0%
Unknown or Not Reported
0
   0.0%
1
   7.1%
1
   3.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 14 participants 33 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.3%
0
   0.0%
1
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   7.1%
1
   3.0%
Black or African American
1
   5.3%
1
   7.1%
2
   6.1%
White
16
  84.2%
11
  78.6%
27
  81.8%
More than one race
1
   5.3%
0
   0.0%
1
   3.0%
Unknown or Not Reported
0
   0.0%
1
   7.1%
1
   3.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 14 participants 33 participants
19
 100.0%
14
 100.0%
33
 100.0%
1.Primary Outcome
Title Arm 1: Progression Free Survival (PFS)
Hide Description Number of anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) naive patients with recurrent glioblastoma (GBM). The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6. Progression is defined using the Response Assessment in Neuro-Oncology (RANO) Criteria where CR = Total disappearance of lesions, PR = >50% reduction in lesions and SD = <25% reduction in lesions
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Hide Arm/Group Description:

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 19 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Arm 2: Determine Median Time to Progression
Hide Description Anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) patients with recurrent glioblastoma (GBM). Time to tumor progression (TTP), is defined as the time from randomization to time of progressive disease. So it is ongoing and will be assessed every 8 weeks …8, 16, 24, 32 …week. Progression is defined as >25% increase in size of lesions or evidence of new lesions
Time Frame From randomization to time of progression every 8 weeks (2 cycles of treatment) up to 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Hide Arm/Group Description:

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 19 14
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.3 to 2.8)
1.8
(0.7 to 1.8)
3.Secondary Outcome
Title Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hide Description Number of adverse events in patients in both populations (grade 1-5). Grade 1 are defined as mild events characterized as asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention indicated. Grade 2 are moderate events with minimal, local or non invasive interventions indicated. Grade 3 are severe or medically significant events but not immediately life-threatening; hospitalization indicated. Grade 4 are life-threatening consequences with urgent intervention indicated. Grade 5 are deaths related to events
Time Frame Assessed until 30 days after treatment up to 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Hide Arm/Group Description:

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 19 14
Measure Type: Number
Unit of Measure: Events
Grade 1 217 119
Grade 2 109 85
Grade 3 55 40
Grade 4 2 5
Grade 5 1 2
4.Secondary Outcome
Title Objective Response Rate Using Modified Revised Assessment in Neuro-Oncology (RANO) Criteria
Hide Description Number of patients (both populations) with a complete response (CR-no measurable disease), partial response (PR >50% reduction in measurable disease), minor response (MR >25% reduction of measurable disease), stable disease (SD <25% reduction) and progressive disease (PD >25% measurable disease and new lesions).
Time Frame Up to 30 days after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Hide Arm/Group Description:

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 19 14
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
Progressive Disease
8
  42.1%
8
  57.1%
Stable Disease
3
  15.8%
2
  14.3%
Unknown
6
  31.6%
4
  28.6%
Partial Response
2
  10.5%
0
   0.0%
5.Secondary Outcome
Title Median Progression Free Survival
Hide Description The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Hide Arm/Group Description:

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 19 14
Median (95% Confidence Interval)
Unit of Measure: Months
2.0
(1.3 to 3.7)
1.8
(0.9 to 1.8)
6.Secondary Outcome
Title Overall Survival
Hide Description The Kaplan-Meier method will be used. Overall survival is defined as the time from randomization to death.
Time Frame to death, approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Hide Arm/Group Description:

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 19 14
Median (95% Confidence Interval)
Unit of Measure: Months
8.0
(4.4 to 11.7)
4.3
(2.6 to 6.7)
7.Other Pre-specified Outcome
Title Changes From Baseline in Circulating Growth Factors and Soluble Receptors.
Hide Description To assess the pharmacodynamic effect of dovitinib on potential plasma biomarkers that may include measuring concentrations of circulating, microparticles, PlGF, PDGF-AA, PDGF-AB, PDGF-BB, SDF-la, thrombospondin-l, Angl, and 11-6, IL-8 and FGF.
Time Frame Up to 30 days after treatment
Outcome Measure Data Not Reported
Time Frame adverse events were monitored for at least 30 days following the last dose of treatment. For this study, the maximum time following a subject was 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Hide Arm/Group Description

Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

dovitinib: Given PO

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)      2/14 (14.29%)    
Show Serious Adverse Events Hide Serious Adverse Events
Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/19 (52.63%)      7/14 (50.00%)    
Blood and lymphatic system disorders     
Anemia * 1  1/19 (5.26%)  1 0/14 (0.00%)  0
Gastrointestinal disorders     
Colitis * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Gastrointestinal disorders - Other, specify * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
General disorders     
Death NOS * 1  1/19 (5.26%)  1 2/14 (14.29%)  2
Fever * 1  1/19 (5.26%)  1 0/14 (0.00%)  0
Infections and infestations     
Infections and infestations - Other, specify * 1  1/19 (5.26%)  1 0/14 (0.00%)  0
Lung infection * 1  1/19 (5.26%)  1 0/14 (0.00%)  0
Skin infection * 1  1/19 (5.26%)  1 0/14 (0.00%)  0
Investigations     
Platelet count decreased * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
White blood cell decreased * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Generalized muscle weakness * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Muscle weakness right-sided * 1  1/19 (5.26%)  1 0/14 (0.00%)  0
Nervous system disorders     
Cognitive disturbance * 1  1/19 (5.26%)  1 1/14 (7.14%)  1
Dizziness * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Dysarthria * 1  1/19 (5.26%)  1 0/14 (0.00%)  0
Dysphasia * 1  1/19 (5.26%)  1 0/14 (0.00%)  0
Intracranial hemorrhage * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Nervous system disorders - Other, specify * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Peripheral motor neuropathy * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Seizure * 1  2/19 (10.53%)  3 1/14 (7.14%)  1
Psychiatric disorders     
Confusion * 1  3/19 (15.79%)  4 0/14 (0.00%)  0
Delirium * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Renal and urinary disorders     
Acute kidney injury * 1  2/19 (10.53%)  2 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Vascular disorders     
Hypertension * 1  0/19 (0.00%)  0 1/14 (7.14%)  1
Thromboembolic event * 1  6/19 (31.58%)  6 2/14 (14.29%)  2
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anti-angiogenic Therapy Naive Patients Anti-angiogenic Therapy Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/19 (100.00%)      14/14 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  4/19 (21.05%)  5 2/14 (14.29%)  3
Cardiac disorders     
Cardiac disorders - Other, specify  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Chest pain - cardiac  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Sinus tachycardia  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Eye disorders     
Eye disorders - Other, specify  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Blurred vision  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Eye pain  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  9/19 (47.37%)  15 9/14 (64.29%)  10
Nausea  1  10/19 (52.63%)  15 2/14 (14.29%)  3
Vomiting  1  4/19 (21.05%)  6 2/14 (14.29%)  2
Constipation  1  3/19 (15.79%)  3 1/14 (7.14%)  1
Dyspepsia  1  0/19 (0.00%)  0 4/14 (28.57%)  5
Dry mouth  1  2/19 (10.53%)  2 1/14 (7.14%)  1
Oral pain  1  0/19 (0.00%)  0 2/14 (14.29%)  2
Abdominal pain  1  1/19 (5.26%)  3 0/14 (0.00%)  0
Colitis  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Fecal incontinence  1  0/19 (0.00%)  0 1/14 (7.14%)  2
Gastroesophageal reflux disease  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Rectal fistula  1  1/19 (5.26%)  1 0/14 (0.00%)  0
General disorders     
Fatigue  1  12/19 (63.16%)  28 7/14 (50.00%)  10
Gait disturbance  1  5/19 (26.32%)  8 3/14 (21.43%)  4
Edema limbs  1  3/19 (15.79%)  4 1/14 (7.14%)  2
Fever  1  4/19 (21.05%)  9 0/14 (0.00%)  0
Chills  1  2/19 (10.53%)  2 0/14 (0.00%)  0
Edema face  1  1/19 (5.26%)  1 1/14 (7.14%)  2
Localized edema  1  2/19 (10.53%)  2 0/14 (0.00%)  0
Facial pain  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Malaise  1  1/19 (5.26%)  3 0/14 (0.00%)  0
Pain  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Immune system disorders     
Allergic reaction  1  1/19 (5.26%)  2 0/14 (0.00%)  0
Infections and infestations     
Urinary tract infection  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Appendicitis  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Infections and infestations - Other, specify  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Lung infection  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Mucosal infection  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Skin infection  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Upper respiratory infection  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising  1  2/19 (10.53%)  2 0/14 (0.00%)  0
Fall  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Fracture  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  12/19 (63.16%)  16 11/14 (78.57%)  15
Platelet count decreased  1  13/19 (68.42%)  17 10/14 (71.43%)  19
Lymphocyte count decreased  1  12/19 (63.16%)  20 6/14 (42.86%)  8
Aspartate aminotransferase increased  1  5/19 (26.32%)  9 6/14 (42.86%)  8
Lipase increased  1  7/19 (36.84%)  12 4/14 (28.57%)  6
Cholesterol high  1  6/19 (31.58%)  6 4/14 (28.57%)  4
White blood cell decreased  1  6/19 (31.58%)  7 4/14 (28.57%)  5
Serum amylase increased  1  5/19 (26.32%)  5 2/14 (14.29%)  3
Weight loss  1  1/19 (5.26%)  1 4/14 (28.57%)  4
Neutrophil count decreased  1  2/19 (10.53%)  4 2/14 (14.29%)  3
GGT increased  1  0/19 (0.00%)  0 2/14 (14.29%)  2
Alkaline phosphatase increased  1  0/19 (0.00%)  0 1/14 (7.14%)  1
CD4 lymphocytes decreased  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Creatinine increased  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Weight gain  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Metabolism and nutrition disorders     
Hypertriglyceridemia  1  15/19 (78.95%)  21 9/14 (64.29%)  15
Hypokalemia  1  4/19 (21.05%)  5 2/14 (14.29%)  2
Hyponatremia  1  1/19 (5.26%)  1 3/14 (21.43%)  3
Anorexia  1  1/19 (5.26%)  1 2/14 (14.29%)  2
Hyperglycemia  1  1/19 (5.26%)  1 1/14 (7.14%)  2
Dehydration  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Hypermagnesemia  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Hypernatremia  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Hypophosphatemia  1  0/19 (0.00%)  0 1/14 (7.14%)  2
Metabolism and nutrition disorders - Other, specify  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness  1  5/19 (26.32%)  11 4/14 (28.57%)  7
Pain in extremity  1  3/19 (15.79%)  5 1/14 (7.14%)  1
Back pain  1  2/19 (10.53%)  3 1/14 (7.14%)  1
Muscle weakness lower limb  1  3/19 (15.79%)  5 0/14 (0.00%)  0
Muscle weakness right-sided  1  1/19 (5.26%)  1 2/14 (14.29%)  2
Muscle weakness left-sided  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Arthralgia  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Flank pain  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Nervous system disorders     
Headache  1  10/19 (52.63%)  17 3/14 (21.43%)  5
Dysphasia  1  3/19 (15.79%)  3 2/14 (14.29%)  3
Seizure  1  4/19 (21.05%)  7 1/14 (7.14%)  3
Dysgeusia  1  3/19 (15.79%)  4 1/14 (7.14%)  1
Dysarthria  1  2/19 (10.53%)  2 1/14 (7.14%)  1
Nervous system disorders - Other, specify  1  1/19 (5.26%)  1 2/14 (14.29%)  2
Cognitive disturbance  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Dizziness  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Concentration impairment  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Facial muscle weakness  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Intracranial hemorrhage  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Memory impairment  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Paresthesia  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Peripheral motor neuropathy  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Tremor  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Psychiatric disorders     
Confusion  1  4/19 (21.05%)  8 4/14 (28.57%)  8
Anxiety  1  2/19 (10.53%)  2 0/14 (0.00%)  0
Insomnia  1  2/19 (10.53%)  5 0/14 (0.00%)  0
Agitation  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Delirium  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Depression  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Personality change  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Restlessness  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Renal and urinary disorders     
Proteinuria  1  3/19 (15.79%)  3 2/14 (14.29%)  2
Urinary incontinence  1  0/19 (0.00%)  0 3/14 (21.43%)  4
Acute kidney injury  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Hematuria  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Renal and urinary disorders - Other, specify  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Urinary frequency  1  1/19 (5.26%)  2 0/14 (0.00%)  0
Urinary urgency  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  2/19 (10.53%)  2 1/14 (7.14%)  1
Cough  1  2/19 (10.53%)  3 0/14 (0.00%)  0
Dyspnea  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Epistaxis  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Hiccups  1  0/19 (0.00%)  0 1/14 (7.14%)  1
Hoarseness  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Sore throat  1  1/19 (5.26%)  1 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  2/19 (10.53%)  5 1/14 (7.14%)  4
Rash maculo-papular  1  2/19 (10.53%)  6 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders - Other, specify  1  1/19 (5.26%)  3 2/14 (14.29%)  6
Dry skin  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Rash acneiform  1  1/19 (5.26%)  1 1/14 (7.14%)  1
Urticaria  1  1/19 (5.26%)  2 0/14 (0.00%)  0
Vascular disorders     
Thromboembolic event  1  7/19 (36.84%)  10 2/14 (14.29%)  3
Hypertension  1  1/19 (5.26%)  1 5/14 (35.71%)  9
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Manmeet Ahluwalia, MD
Organization: Case Comprehensive Cancer Center
Phone: 216-844-5060
Responsible Party: Manmeet Ahluwalia, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01753713     History of Changes
Other Study ID Numbers: CASE4312
NCI-2012-02284 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: December 18, 2012
First Posted: December 20, 2012
Results First Submitted: April 14, 2017
Results First Posted: August 8, 2017
Last Update Posted: December 12, 2017