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Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression

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ClinicalTrials.gov Identifier: NCT01732107
Recruitment Status : Terminated (Development of dovitinib was stopped.)
First Posted : November 22, 2012
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
Novartis Pharmaceuticals
Hoosier Cancer Research Network
Information provided by (Responsible Party):
Noah Hahn, M.D., Hoosier Cancer Research Network

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bladder Cancer
Intervention Drug: Dovitinib
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dovitinib
Hide Arm/Group Description

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Period Title: Overall Study
Started 13
Completed 0
Not Completed 13
Reason Not Completed
Adverse Event             2
Disease Progression             8
Physician Decision             1
Withdrawal by Subject             2
Arm/Group Title Dovitinib
Hide Arm/Group Description

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
70
(57 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
2
  15.4%
Male
11
  84.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
2
  15.4%
Not Hispanic or Latino
11
  84.6%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   7.7%
White
11
  84.6%
More than one race
0
   0.0%
Unknown or Not Reported
1
   7.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Determine 6-Month Complete Response Rate
Hide Description The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percentage of participants
8
2.Secondary Outcome
Title Determine 1-Year Relapse-Free Survival Rate
Hide Description The 1-year relapse free survival rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors at 12 months of follow-up.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Determine Rate of Progression to Muscle-Invasive Stage
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Determine 3-Month and 6-Month Partial Response Rates
Hide Description The 3- and 6-month partial response rates are defined as the proportion of patients treated with persistent but reduced T-stage tumors on post-therapy TURBT (i.e., T1 ≥ Ta; T1+Tis ≥ T1).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Characterize Treatment-related Toxicity Rates
Hide Description Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All grade 3-4 adverse events and other adverse events occurring in more than 20% of patients are reported.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Fatigue (Grade 1) 5
Fatigue (Grade 2) 4
Fatigue (Grade 3) 2
Pain (Grade 1) 6
Pain (Grade 2) 6
Other Constitutional (Grade 1) 3
Other Constitutional (Grade 2) 2
Fall (Grade 3) 1
Hypertension (Grade 2) 2
Hypertension (Grade 3) 2
Headache (Grade 1) 5
Headache (Grade 2) 1
Headache (Grade 3) 1
Intracranial Hemmorage (Grade 3) 1
GERD (Grade 1) 2
GERD (Grade 2) 3
GERD (Grade 3) 2
Constipation (Grade 1) 2
Constipation (Grade 2) 2
Diarrhea (Grade 1) 8
Diarrhea (Grade 2) 2
Anorexia (Grade 1) 4
Anorexia (Grade 2) 1
Weight loss (Grade 1) 4
Dysgeusia (Grade 1) 5
Dysgeusia (Grade 2) 2
Nausea/Emesis (Grade 1) 6
Emesis (Grade 1) 4
Other gastrointestinal (Grade 1) 2
Other gastrointestinal (Grade 2) 3
Stomatitis (Grade 3) 1
Rash (Grade 1) 4
Rash (Grade 2) 1
Rash (Grade 3) 1
Hand–foot syndrome (Grade 1) 2
Hand–foot syndrome (Grade 2) 1
Dry mouth (Grade 1) 4
Other skin (Grade 1) 6
Other skin (Grade 2) 2
Bladder spasms (Grade 2) 3
Other urinary (Grade 1) 7
Other urinary (Grade 2) 1
Fever (Grade 1) 4
Infection (Grade 2) 8
Hoarseness (Grade 1) 3
Other pulmonary (Grade 1) 4
Other pulmonary (Grade 2) 2
Arthralgia/Myalgia (Grade 1) 4
Arthralgia/Myalgia (Grade 2) 2
Hypertriglyceridemia (Grade 1) 1
Hypertriglyceridemia (Grade 2) 2
Hypertriglyceridemia (Grade 3) 1
Hypertriglyceridemia (Grade 4) 1
Elevated alkaline phosphatase (Grade 1) 2
Elevated alkaline phosphatase (Grade 2) 1
Elevated GGT (Grade 2) 1
Elevated GGT (Grade 3) 2
Hypoalbuminemia (Grade 1) 2
Hypoalbuminemia (Grade 2) 1
Elevated lipase (Grade 3) 2
Other metabolic (Grade 1) 6
Anemia (Grade 1) 4
6.Other Pre-specified Outcome
Title Characterize Pre- and Post-treatment Bladder Tumor FGFR Pathway Phosphorylation Changes.
Hide Description Pre- and post-treatment bladder tumor FGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: fibroblast growth factor receptors (FGFR3, pFGFR3), vascular endothelial growth factor receptors (VEGFR2, pVEGFR2), fibroblast growth factor receptor substrates (2FRS2, pFRS2), extracellular signal-regulated kinases (ERK), phosphorylated extracellular signal-related kinase (pERK).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title Characterize Associations Between Pre-treatment Germline, FGFR Single-nucleotide Polymorphisms (SNPs) and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.
Hide Description Pre-treatment germline FGFR SNPs will be assessed by testing extracted Deoxyribonucleic acid (DNA) from patient peripheral blood mononuclear cells (PBMC's) (collected prior to initiating dovitinib therapy) with validated commercial probes.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Characterize Pre- and Post-treatment VEGFR Pathway Phosphorylation Changes as Assessed by Bladder Tumor Tissue Immunohistochemistry.
Hide Description Pre- and post-treatment bladder tumor VEGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: FGFR3, pFGFR3, VEGFR2, pVEGFR2, FRS2, pFRS2, ERK, pERK.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Other Pre-specified Outcome
Title Characterize Associations Between Pre-treatment Germline VEGFR SNPs and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.
Hide Description Pre-treatment germline VEGFR SNPs will be assessed by testing extracted DNA from patient PBMC’s (collected prior to initiating dovitinib therapy) with validated commercial probes.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title Characterize Associations Between Post-treatment Hypertension, 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.
Hide Description Hypertension will be defined as a systolic blood pressure (SBP) of > 140 mmHg or a diastolic blood pressure (DBP) of > 90 mm Hg recorded at any time after dovitinib therapy is initiated.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Other Pre-specified Outcome
Title Characterize Concordance Rates Between UC Patient Detected Tumor, Urine, and Circulating Free Plasma FGFR3 Mutations.
Hide Description Presence of FGFR3 mutations within patient free plasma will be assessed by polymerase chain reaction (PCR) amplification of the target regions and sequencing.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was neither collected or analyzed due to the early termination of the study.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Other Pre-specified Outcome
Title Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.
Hide Description Post-treatment bladder tissue dovitinib concentrations will be assessed by TURBT fresh frozen tissue obtained at the 3-month cystoscopy
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
9 subjects had sufficient tissue available to measure dovitinib tissue concentration
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: nmol/L
Subject 2 1603
Subject 3 159
Subject 6 5813
Subject 7 812
Subject 8 726
Subject 10 1135
Subject 11 94
Subject 12 2115
Subject 13 2483
Time Frame Duration of participation of the treatment portion of the study, up to six cycles (6 Months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dovitinib
Hide Arm/Group Description

Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule.

Dovitinib: Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

All-Cause Mortality
Dovitinib
Affected / at Risk (%)
Total   0/13 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dovitinib
Affected / at Risk (%) # Events
Total   3/13 (23.08%)    
Gastrointestinal disorders   
CONSTIPATION * 1  1/13 (7.69%)  1
Nervous system disorders   
INTRACRANIAL HEMORRHAGE * 1  1/13 (7.69%)  1
Renal and urinary disorders   
ACUTE KIDNEY INJURY * 1  1/13 (7.69%)  1
1
Term from vocabulary, CTCAEv4
*
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%
Dovitinib
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
ANEMIA * 1  6/13 (46.15%)  9
Cardiac disorders   
CARDIAC DISORDERS * 1  1/13 (7.69%)  1
CHEST PAIN - CARDIAC * 1  1/13 (7.69%)  2
CONDUCTION DISORDER * 1  1/13 (7.69%)  1
SINUS BRADYCARDIA * 1  1/13 (7.69%)  1
Ear and labyrinth disorders   
EAR AND LABYRINTH DISORDERS * 1  1/13 (7.69%)  1
HEARING IMPAIRED * 1  1/13 (7.69%)  1
Eye disorders   
BLURRED VISION * 1  1/13 (7.69%)  1
CATARACT * 1  1/13 (7.69%)  2
CONJUNCTIVITIS * 1  1/13 (7.69%)  1
WATERING EYES * 1  1/13 (7.69%)  1
Gastrointestinal disorders   
ABDOMINAL DISTENSION * 1  1/13 (7.69%)  1
ABDOMINAL PAIN * 1  2/13 (15.38%)  3
CONSTIPATION * 1  6/13 (46.15%)  8
DIARRHEA * 1  10/13 (76.92%)  15
DRY MOUTH * 1  4/13 (30.77%)  4
DYSPEPSIA * 1  2/13 (15.38%)  2
ESOPHAGEAL PAIN * 1  1/13 (7.69%)  1
FECAL INCONTINENCE * 1  1/13 (7.69%)  1
FLATULENCE * 1  2/13 (15.38%)  2
GASTROESOPHAGEAL REFLUX DISEASE * 1  2/13 (15.38%)  3
GASTROINTESTINAL DISORDERS * 1  1/13 (7.69%)  1
NAUSEA * 1  6/13 (46.15%)  8
ORAL PAIN * 1  1/13 (7.69%)  2
STOMACH PAIN * 1  2/13 (15.38%)  2
TOOTHACHE * 1  1/13 (7.69%)  1
VOMITING * 1  4/13 (30.77%)  4
General disorders   
CHILLS * 1  1/13 (7.69%)  1
FATIGUE * 1  11/13 (84.62%)  18
FEVER * 1  4/13 (30.77%)  7
FLU LIKE SYMPTOMS * 1  1/13 (7.69%)  1
MALAISE * 1  1/13 (7.69%)  3
PAIN * 1  2/13 (15.38%)  3
Hepatobiliary disorders   
HEPATOBILIARY DISORDERS * 1  1/13 (7.69%)  2
Infections and infestations   
EYE INFECTION * 1  1/13 (7.69%)  1
PAPULOPUSTULAR RASH * 1  1/13 (7.69%)  1
SINUSITIS * 1  1/13 (7.69%)  1
SKIN INFECTION * 1  1/13 (7.69%)  1
UPPER RESPIRATORY INFECTION * 1  1/13 (7.69%)  1
URINARY TRACT INFECTION * 1  4/13 (30.77%)  4
Injury, poisoning and procedural complications   
BRUISING * 1  1/13 (7.69%)  1
FALL * 1  1/13 (7.69%)  2
INJURY, POISONING AND PROCEDURAL COMPLICATIONS * 1  1/13 (7.69%)  1
Investigations   
ALANINE AMINOTRANSFERASE INCREASED * 1  1/13 (7.69%)  3
ALKALINE PHOSPHATASE INCREASED * 1  3/13 (23.08%)  5
ASPARTATE AMINOTRANSFERASE INCREASED * 1  1/13 (7.69%)  4
CHOLESTEROL HIGH * 1  3/13 (23.08%)  6
CREATININE INCREASED * 1  1/13 (7.69%)  1
GGT INCREASED * 1  3/13 (23.08%)  12
INVESTIGATIONS * 1  1/13 (7.69%)  1
LIPASE INCREASED * 1  3/13 (23.08%)  5
LYMPHOCYTE COUNT DECREASED * 1  1/13 (7.69%)  1
NEUTROPHIL COUNT DECREASED * 1  1/13 (7.69%)  3
PLATELET COUNT DECREASED * 1  2/13 (15.38%)  2
SERUM AMYLASE INCREASED * 1  1/13 (7.69%)  1
WEIGHT LOSS * 1  4/13 (30.77%)  4
Metabolism and nutrition disorders   
ANOREXIA * 1  5/13 (38.46%)  6
HYPERCALCEMIA * 1  1/13 (7.69%)  1
HYPERGLYCEMIA * 1  3/13 (23.08%)  3
HYPERNATREMIA * 1  1/13 (7.69%)  1
HYPERTRIGLYCERIDEMIA * 1  5/13 (38.46%)  17
HYPOALBUMINEMIA * 1  3/13 (23.08%)  3
HYPOKALEMIA * 1  2/13 (15.38%)  2
HYPOMAGNESEMIA * 1  2/13 (15.38%)  4
HYPOPHOSPHATEMIA * 1  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorders   
ARTHRALGIA * 1  1/13 (7.69%)  1
BACK PAIN * 1  4/13 (30.77%)  4
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER * 1  1/13 (7.69%)  1
MYALGIA * 1  2/13 (15.38%)  2
PAIN IN EXTREMITY * 1  2/13 (15.38%)  2
Nervous system disorders   
DIZZINESS * 1  2/13 (15.38%)  2
DYSARTHRIA * 1  1/13 (7.69%)  1
DYSGEUSIA * 1  7/13 (53.85%)  9
HEADACHE * 1  8/13 (61.54%)  10
PARESTHESIA * 1  1/13 (7.69%)  1
PERIPHERAL SENSORY NEUROPATHY * 1  3/13 (23.08%)  3
Psychiatric disorders   
ANXIETY * 1  2/13 (15.38%)  2
DEPRESSION * 1  2/13 (15.38%)  2
INSOMNIA * 1  2/13 (15.38%)  2
PSYCHIATRIC DISORDERS * 1  1/13 (7.69%)  1
Renal and urinary disorders   
BLADDER SPASM * 1  4/13 (30.77%)  7
CYSTITIS NONINFECTIVE * 1  1/13 (7.69%)  1
HEMATURIA * 1  3/13 (23.08%)  3
URINARY FREQUENCY * 1  6/13 (46.15%)  6
URINARY TRACT PAIN * 1  1/13 (7.69%)  1
URINARY URGENCY * 1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
COUGH * 1  1/13 (7.69%)  1
DYSPNEA * 1  1/13 (7.69%)  1
HOARSENESS * 1  3/13 (23.08%)  3
NASAL CONGESTION * 1  1/13 (7.69%)  1
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS * 1  1/13 (7.69%)  1
SORE THROAT * 1  1/13 (7.69%)  1
VOICE ALTERATION * 1  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
DRY SKIN * 1  1/13 (7.69%)  1
PAIN OF SKIN * 1  1/13 (7.69%)  1
PRURITUS * 1  1/13 (7.69%)  1
RASH ACNEIFORM * 1  3/13 (23.08%)  4
RASH MACULO-PAPULAR * 1  4/13 (30.77%)  4
SKIN AND SUBCUTANEOUS TISSUE DISORDERS * 1  2/13 (15.38%)  4
SKIN HYPOPIGMENTATION * 1  1/13 (7.69%)  1
SKIN ULCERATION * 1  1/13 (7.69%)  1
Vascular disorders   
HYPERTENSION * 1  6/13 (46.15%)  27
1
Term from vocabulary, CTCAEv4
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Clinical Data Coordinator
Organization: Hoosier Cancer Research Network
Phone: 317-921-2050
Responsible Party: Noah Hahn, M.D., Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01732107     History of Changes
Other Study ID Numbers: GU12-157
First Submitted: November 19, 2012
First Posted: November 22, 2012
Results First Submitted: July 25, 2018
Results First Posted: August 22, 2018
Last Update Posted: August 22, 2018