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Trial record 60 of 78 for:    vismodegib

Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas

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: NCT01088815
Recruitment Status : Completed
First Posted : March 17, 2010
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Stand Up To Cancer
Genentech, Inc.
Celgene Corporation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Intervention Drug: Gemcitabine, nab-Paclitaxel, GDC-0449
Enrollment 98
Recruitment Details  
Pre-assignment Details 98 subjects signed consents in total. 26 subjects were screen-fails
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
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Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Period Title: Overall Study
Started 72
Completed 72
Not Completed 0
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
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Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
  55.6%
>=65 years
32
  44.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 72 participants
62.05
(18 to 100)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
35
  48.6%
Male
37
  51.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
71
  98.6%
Unknown or Not Reported
1
   1.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   2.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   6.9%
White
64
  88.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 72 participants
72
 100.0%
1.Primary Outcome
Title Progression Free Survival With the Combination of GDC-0449 With Gemcitabine and Nab-paclitaxel.
Hide Description Number of months from time first therapy received to the earliest documented disease progression or death from any cause.
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was evaluable in only in 67/72 participants.
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
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Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Overall Number of Participants Analyzed 67
Median (95% Confidence Interval)
Unit of Measure: months
5.42
(4.37 to 6.97)
2.Primary Outcome
Title Safety of Combination Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas as Assessed by Number of Grade 3 or 4 Adverse Events
Hide Description Number of grade 3 or 4 adverse events as defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE v4.0) that occur after Cycle 2, Day 1
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
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Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Grade 3/4 adverse events
104
3.Secondary Outcome
Title Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Overall Survival
Hide Description Total number of months alive.
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was evaluable in only 67/72 participants for this outcome measure
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
Hide Arm/Group Description:

Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Overall Number of Participants Analyzed 67
Median (95% Confidence Interval)
Unit of Measure: months
9.79
(7.85 to 10.97)
4.Secondary Outcome
Title Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Tumor Response
Hide Description Number of participants with complete (CR) or partial (PR) response as defined by RECIST criteria.
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was evaluable in only 67/72 participants for this outcome measure
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
Hide Arm/Group Description:

Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Overall Number of Participants Analyzed 67
Measure Type: Count of Participants
Unit of Measure: Participants
CR
1
   1.5%
PR
26
  38.8%
5.Secondary Outcome
Title Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Changes in Pancreatic Cancer Stem Cell
Hide Description Change in number of Pancreatic cancer stem cells in tissue and peripheral blood in tissue biopsy and peripheral blood.
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Peripheral blood data was collected from only 57/72 participants. Tissue biopsy data was not evaluable for analysis due to inadequate biopsy samples for all 23/72 participants who underwent biopsy
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
Hide Arm/Group Description:

Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Overall Number of Participants Analyzed 72
Mean (Standard Deviation)
Unit of Measure: cells
peripheral blood Number Analyzed 57 participants
27.0  (4.0)
tissue biopsy Number Analyzed 0 participants
6.Secondary Outcome
Title Efficacy of Combination of GDC-0449 With Gemcitabine and Nab-Paclitaxel as Assessed by Hedgehog Signaling Pathway Downregulation
Hide Description Hedgehog signaling pathway downregulation as measured by Gli-1 and Patch expression
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure.
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
Hide Arm/Group Description:

Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine, Nab-paclitaxel, GDC-0449
Hide Arm/Group Description

Gemcitabine and nab-Paclitaxel in combination with GDC-0449 (Vismodegib)

Gemcitabine, nab-Paclitaxel, GDC-0449: 1. One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then 2. Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily

All-Cause Mortality
Gemcitabine, Nab-paclitaxel, GDC-0449
Affected / at Risk (%)
Total   64/72 (88.89%)    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine, Nab-paclitaxel, GDC-0449
Affected / at Risk (%) # Events
Total   46/72 (63.89%)    
Blood and lymphatic system disorders   
Abdominal Distension * 1  1/72 (1.39%)  1
Febrile Neutropenia * 1  2/72 (2.78%)  2
Anemia * 1  3/72 (4.17%)  3
Blood Bilirubin Increased * 1  1/72 (1.39%)  1
Blood/Lymph Disorder * 1  1/72 (1.39%)  1
Cardiac disorders   
Atrial Fibrillation * 1  1/72 (1.39%)  1
Heart Failure * 1  1/72 (1.39%)  1
Myocardial Infarction * 1  1/72 (1.39%)  1
Pericardial Effusion * 1  1/72 (1.39%)  1
Eye disorders   
Ileus * 1  1/72 (1.39%)  2
Gastrointestinal disorders   
Abdominal Pain * 1  2/72 (2.78%)  2
Ascites * 1  1/72 (1.39%)  1
Diarrhea * 1  1/72 (1.39%)  1
Duodenal Obstruction * 1  1/72 (1.39%)  1
Gallbladder Infection * 1  1/72 (1.39%)  1
Gastroparesis * 1  1/72 (1.39%)  1
GI disorders * 1  2/72 (2.78%)  3
Nausea * 1  1/72 (1.39%)  1
Obstruction Gastric * 1  1/72 (1.39%)  1
Small Intestinal Obstruction * 1  1/72 (1.39%)  1
Upper GI Hemorrhage * 1  2/72 (2.78%)  4
Vomiting * 1  2/72 (2.78%)  2
General disorders   
Death * 1  5/72 (6.94%)  5
Fatigue * 1  1/72 (1.39%)  1
Fever * 1  8/72 (11.11%)  9
General Disorders/Administration Site * 1  1/72 (1.39%)  1
Hepatobiliary disorders   
Hepatobil Disorders * 1  4/72 (5.56%)  4
Infections and infestations   
Infestion/Infestation-Other * 1  2/72 (2.78%)  2
Sepsis * 1  6/72 (8.33%)  6
Splenic Infection * 1  1/72 (1.39%)  1
Wound Infection * 1  1/72 (1.39%)  1
Investigations   
Investigations-Other * 1  4/72 (5.56%)  4
Neutrophil Count Decreased * 1  2/72 (2.78%)  2
Platelet Count Decreased * 1  2/72 (2.78%)  2
Metabolism and nutrition disorders   
Dehyrdation * 1  4/72 (5.56%)  4
Hyponatremia * 1  2/72 (2.78%)  2
Musculoskeletal and connective tissue disorders   
Pain in Extremity * 1  1/72 (1.39%)  1
Nervous system disorders   
Lethargy * 1  1/72 (1.39%)  1
Stroke * 1  1/72 (1.39%)  1
Syncope * 1  1/72 (1.39%)  2
Renal and urinary disorders   
Acute Kidney Injury * 1  1/72 (1.39%)  1
Kidney Infection * 1  1/72 (1.39%)  1
Urinary Tract Obstruction * 1  1/72 (1.39%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/72 (1.39%)  1
Pneumonitis * 1  4/72 (5.56%)  4
Respiratory/Thoracic/Mediastinal Disorder * 1  1/72 (1.39%)  1
Skin and subcutaneous tissue disorders   
Skin Infection * 1  4/72 (5.56%)  4
Vascular disorders   
Hematoma * 1  2/72 (2.78%)  2
Hypotension * 1  2/72 (2.78%)  2
Thromboembolic * 1  4/72 (5.56%)  4
Vascular Access Complication * 1  1/72 (1.39%)  1
1
Term from vocabulary, NCI CTCAE V4.0
*
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%
Gemcitabine, Nab-paclitaxel, GDC-0449
Affected / at Risk (%) # Events
Total   72/72 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  56/72 (77.78%)  232
Blood Bilirubin Increased * 1  12/72 (16.67%)  19
Blood/Lymph Disorder * 1  4/72 (5.56%)  4
Febrile Neutropenia * 1  2/72 (2.78%)  2
Leukocytosis * 1  3/72 (4.17%)  3
Cardiac disorders   
Atrial Fibrillation * 1  1/72 (1.39%)  1
Atrial Flutter * 1  1/72 (1.39%)  1
Cardiac Troponin I Increased * 1  1/72 (1.39%)  1
Cardiac Troponin T Increased * 1  1/72 (1.39%)  1
Chest Pain - Cardiac * 1  1/72 (1.39%)  1
ECG QT Corrected int prolong * 1  1/72 (1.39%)  1
Pericardial effusion * 1  6/72 (8.33%)  7
Right ventricular dysfunction * 1  1/72 (1.39%)  2
Sinus tachycardia * 1  1/72 (1.39%)  1
Syncope * 1  2/72 (2.78%)  2
Eye disorders   
Dry Eye * 1  1/72 (1.39%)  1
Eye Disorder - Other * 1  2/72 (2.78%)  2
Photophobia * 1  1/72 (1.39%)  1
Watering eyes * 1  1/72 (1.39%)  1
Gastrointestinal disorders   
Abdominal Distension * 1  5/72 (6.94%)  5
Abdominal Pain * 1  19/72 (26.39%)  23
Anal Hemorrhage * 1  1/72 (1.39%)  1
Ascites * 1  12/72 (16.67%)  14
Bloating * 1  3/72 (4.17%)  3
Constipation * 1  17/72 (23.61%)  21
Diarrhea * 1  30/72 (41.67%)  43
Dry Mouth * 1  6/72 (8.33%)  8
Duodenal Perforation * 1  1/72 (1.39%)  1
Dyspepsia * 1  2/72 (2.78%)  2
dysphagia * 1  2/72 (2.78%)  3
Esophagitis * 1  1/72 (1.39%)  1
Fecal incontinence * 1  1/72 (1.39%)  1
Flatulence * 1  6/72 (8.33%)  6
Gastric Ulcer * 1  1/72 (1.39%)  1
Gastritis * 1  2/72 (2.78%)  2
GERD * 1  3/72 (4.17%)  3
GI disorders - other * 1  11/72 (15.28%)  14
Hemorrhoidal Hemorrhage * 1  2/72 (2.78%)  2
Hemorrhoids * 1  1/72 (1.39%)  1
Mucositis oral * 1  8/72 (11.11%)  9
Nausea * 1  41/72 (56.94%)  56
Oral dysesthesia * 1  1/72 (1.39%)  1
Oral Pain * 1  1/72 (1.39%)  1
Periodontal disease * 1  1/72 (1.39%)  2
Rectal hemorrhage * 1  1/72 (1.39%)  3
Small intestinal obstruction * 1  1/72 (1.39%)  2
Stomach Pain * 1  2/72 (2.78%)  3
Vomiting * 1  30/72 (41.67%)  40
General disorders   
Chills * 1  14/72 (19.44%)  15
Edema Face * 1  1/72 (1.39%)  1
Edema Limbs * 1  28/72 (38.89%)  52
Fatigue * 1  49/72 (68.06%)  97
Fever * 1  22/72 (30.56%)  38
Flu like symptoms * 1  12/72 (16.67%)  16
Gait Disturbance * 1  4/72 (5.56%)  5
General disorders/admin site conditions * 1  5/72 (6.94%)  5
Localized edema * 1  5/72 (6.94%)  5
Malaise * 1  2/72 (2.78%)  4
Pain * 1  11/72 (15.28%)  12
Hepatobiliary disorders   
Bile Duct Stenosis * 1  1/72 (1.39%)  1
Hepatobil disorders - other * 1  1/72 (1.39%)  1
Infections and infestations   
Infections/Infestactions - Other * 1  10/72 (13.89%)  13
Lung infection * 1  4/72 (5.56%)  4
Mucosal infection * 1  3/72 (4.17%)  4
Sinusitis * 1  5/72 (6.94%)  5
Skin infection * 1  7/72 (9.72%)  11
Wound infection * 1  2/72 (2.78%)  4
Injury, poisoning and procedural complications   
Fall * 1  1/72 (1.39%)  1
Infusion site extravasation * 1  1/72 (1.39%)  1
Injection site reaction * 1  1/72 (1.39%)  1
Vascular access complication * 1  1/72 (1.39%)  1
Investigations   
Alkaline Phosphatase Increased * 1  23/72 (31.94%)  38
ALT Increased * 1  34/72 (47.22%)  60
APTT Prolonged * 1  4/72 (5.56%)  7
AST Increased * 1  35/72 (48.61%)  53
CD34 Lymphocytes Decreased * 1  1/72 (1.39%)  1
CPK Increased * 1  1/72 (1.39%)  1
Creatinine Increased * 1  9/72 (12.50%)  11
INR Increased * 1  8/72 (11.11%)  10
Investigations-Other, specify * 1  8/72 (11.11%)  12
Lipase increased * 1  2/72 (2.78%)  3
Lymphocyte count decreased * 1  41/72 (56.94%)  175
Lymphocyte count increased * 1  4/72 (5.56%)  4
Neutrophil count decreased * 1  41/72 (56.94%)  138
Platelet count decreased * 1  44/72 (61.11%)  155
Weight gain * 1  3/72 (4.17%)  3
Weight loss * 1  16/72 (22.22%)  26
White blood cell decreased * 1  51/72 (70.83%)  285
Metabolism and nutrition disorders   
Alkalosis * 1  1/72 (1.39%)  1
Anorexia * 1  26/72 (36.11%)  37
Dehydration * 1  11/72 (15.28%)  37
Hypercalcemia * 1  1/72 (1.39%)  1
Hyperglycemia * 1  31/72 (43.06%)  65
Hyperkalemia * 1  12/72 (16.67%)  15
Hypermagnesemia * 1  5/72 (6.94%)  6
Hypoalbuminemia * 1  33/72 (45.83%)  91
Hypocalcemia * 1  29/72 (40.28%)  60
Hypoglycemia * 1  3/72 (4.17%)  5
Hypokalemia * 1  20/72 (27.78%)  37
Hypomagnesemia * 1  9/72 (12.50%)  15
Hyponatremia * 1  24/72 (33.33%)  47
Hypophosphatemia * 1  11/72 (15.28%)  19
Metabolism/nutrition disorders-Other * 1  1/72 (1.39%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  3/72 (4.17%)  3
Back Pain * 1  6/72 (8.33%)  6
Chest Wall Pain * 1  1/72 (1.39%)  1
Flank Pain * 1  3/72 (4.17%)  3
Fracture * 1  2/72 (2.78%)  2
Generalized Muscle Weakness * 1  6/72 (8.33%)  8
Musculoskeletal and connective tissue disorder * 1  12/72 (16.67%)  24
Muscle weakness lower limb * 1  2/72 (2.78%)  2
Myalgia * 1  9/72 (12.50%)  12
Neck Pain * 1  1/72 (1.39%)  1
Non-Cardiac Chest Pain * 1  2/72 (2.78%)  2
Pain in extremity * 1  6/72 (8.33%)  7
Nervous system disorders   
Dizziness * 1  18/72 (25.00%)  18
Dysarthria * 1  1/72 (1.39%)  1
Dysgeusia * 1  53/72 (73.61%)  74
Dysphasia * 1  1/72 (1.39%)  1
Extrapyramidal Disorder * 1  1/72 (1.39%)  1
Facial Nerve Disorder * 1  1/72 (1.39%)  1
Headache * 1  6/72 (8.33%)  8
Intracranial hemorrhage * 1  1/72 (1.39%)  1
Lethargy * 1  2/72 (2.78%)  2
Nervous system disorders - other * 1  6/72 (8.33%)  8
Oculomotor nerve disorder * 1  1/72 (1.39%)  1
Paresthesia * 1  9/72 (12.50%)  17
Peripheral motor neuropathy * 1  16/72 (22.22%)  27
Peripheral sensory neuropathy * 1  36/72 (50.00%)  77
Presyncope * 1  1/72 (1.39%)  2
Restlessness * 1  1/72 (1.39%)  1
Seizure * 1  1/72 (1.39%)  1
Tremor * 1  1/72 (1.39%)  1
Psychiatric disorders   
Agitation * 1  1/72 (1.39%)  1
Anxiety * 1  7/72 (9.72%)  7
Concentration Impairment * 1  1/72 (1.39%)  1
Confusion * 1  4/72 (5.56%)  7
Depression * 1  6/72 (8.33%)  6
Hallucinations * 1  1/72 (1.39%)  1
Insomnia * 1  6/72 (8.33%)  6
Psych disorders-Other, spec * 1  1/72 (1.39%)  1
Renal and urinary disorders   
Hematuria * 1  2/72 (2.78%)  2
Hemoglobinuria * 1  1/72 (1.39%)  1
Proteinuria * 1  5/72 (6.94%)  6
Renal/urinary disorders-Other * 1  4/72 (5.56%)  5
Urinary frequency * 1  1/72 (1.39%)  1
Urinary retention * 1  2/72 (2.78%)  2
Urinary tract infection * 1  4/72 (5.56%)  4
Urine discoloration * 1  1/72 (1.39%)  1
Reproductive system and breast disorders   
Breast Pain * 1  1/72 (1.39%)  1
Genital Edema * 1  3/72 (4.17%)  3
Prostatic obstruction * 1  1/72 (1.39%)  1
Repro system/breast ds-Oth * 1  1/72 (1.39%)  1
Uterine hemorrhage * 1  1/72 (1.39%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic Rhinitis * 1  1/72 (1.39%)  1
Atelectasis * 1  9/72 (12.50%)  9
Cough * 1  17/72 (23.61%)  19
Dyspnea * 1  23/72 (31.94%)  30
Epistaxis * 1  10/72 (13.89%)  10
Hiccups * 1  1/72 (1.39%)  1
Hoarseness * 1  2/72 (2.78%)  2
Hypoxia * 1  2/72 (2.78%)  2
Laryngeal inflammation * 1  1/72 (1.39%)  1
Pleural effusion * 1  14/72 (19.44%)  15
Pneumonitis * 1  4/72 (5.56%)  4
Postnasal drip * 1  10/72 (13.89%)  10
Productive Cough * 1  3/72 (4.17%)  3
Pulmonary hypertension * 1  1/72 (1.39%)  1
Resp/thoracic/mediastinal ds * 1  2/72 (2.78%)  3
Sinus disorder * 1  3/72 (4.17%)  3
Sore throat * 1  1/72 (1.39%)  1
Upper respiratory infection * 1  3/72 (4.17%)  5
Voice alteration * 1  1/72 (1.39%)  1
Wheezing * 1  1/72 (1.39%)  2
Skin and subcutaneous tissue disorders   
Alopecia * 1  46/72 (63.89%)  58
Bruising * 1  5/72 (6.94%)  5
Bullous Dermatitis * 1  1/72 (1.39%)  1
Dry Skin * 1  4/72 (5.56%)  5
Erythema Multiforme * 1  3/72 (4.17%)  5
Erythroderma * 1  1/72 (1.39%)  3
Hyperhidrosis * 1  1/72 (1.39%)  1
Nail discoloration * 1  4/72 (5.56%)  4
Nail Loss * 1  4/72 (5.56%)  4
Neck Edema * 1  1/72 (1.39%)  1
Periorbital edema * 1  1/72 (1.39%)  1
Pruritus * 1  12/72 (16.67%)  14
Rash acneiform * 1  30/72 (41.67%)  36
Rash maculo-papular * 1  11/72 (15.28%)  19
Scalp pain * 1  1/72 (1.39%)  1
Skin hyperpigmentation * 1  3/72 (4.17%)  3
Skin hypopigmentation * 1  1/72 (1.39%)  1
Skin ulceration * 1  2/72 (2.78%)  2
Skin/subq tissue ds-Other * 1  9/72 (12.50%)  17
Vascular disorders   
Hematoma * 1  1/72 (1.39%)  1
Hypertension * 1  2/72 (2.78%)  3
Hypotension * 1  12/72 (16.67%)  19
Thromboembolic event * 1  16/72 (22.22%)  17
Vasc disorders-Other, spec * 1  3/72 (4.17%)  3
1
Term from vocabulary, NCI CTCAE V4.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ana De Jesus Acosta
Organization: Johns Hopkins SKCCC
Phone: 443-287-0411 ext 7-0411
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01088815     History of Changes
Other Study ID Numbers: J1013
NA_00036883 ( Other Identifier: JHM IRB )
First Submitted: March 1, 2010
First Posted: March 17, 2010
Results First Submitted: April 2, 2019
Results First Posted: April 26, 2019
Last Update Posted: April 26, 2019