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Phase II Trial of Vandetanib in Children and Adults With Wild-Type Gastrointestinal Stromal Tumors

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: NCT02015065
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : July 23, 2019
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Brigitte Widemann, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition GIST
Intervention Drug: Vandetanib
Enrollment 9
Recruitment Details  
Pre-assignment Details Due to lack of efficacy no participants were enrolled in Dose Level 150mg/m^2 Vandetanib Pediatric Arm/Group.
Arm/Group Title 200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Hide Arm/Group Description Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.

Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.

If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose

 Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
Period Title: Overall Study
Started 2 5 2
Completed 1 3 1
Not Completed 1 2 1
Reason Not Completed
Death on study             1             2             1
Arm/Group Title 200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric Total
Hide Arm/Group Description Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.

Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.

If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose

 Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days. Total of all reporting groups
Overall Number of Baseline Participants 2 5 2 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 5 participants 2 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
2
 100.0%
2
  22.2%
Between 18 and 65 years
2
 100.0%
5
 100.0%
0
   0.0%
7
  77.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 5 participants 2 participants 9 participants
24.5  (3.0) 34.3  (13.17) 13.2  (2.12) 27.42  (13.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 5 participants 2 participants 9 participants
Female
1
  50.0%
4
  80.0%
2
 100.0%
7
  77.8%
Male
1
  50.0%
1
  20.0%
0
   0.0%
2
  22.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 2 participants 5 participants 2 participants 9 participants
Not meeting definition for Hispanic or Latino
2
 100.0%
5
 100.0%
1
  50.0%
8
  88.9%
Mexican, Puerto Rican, Cuban, Central or So. Amer.
0
   0.0%
0
   0.0%
1
  50.0%
1
  11.1%
Black or African American
1
  50.0%
0
   0.0%
0
   0.0%
1
  11.1%
White
1
  50.0%
5
 100.0%
0
   0.0%
6
  66.7%
Asian
0
   0.0%
0
   0.0%
1
  50.0%
1
  11.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 5 participants 2 participants 9 participants
2
 100.0%
5
 100.0%
2
 100.0%
9
 100.0%
1.Primary Outcome
Title Number of Participants With a Clinical Activity-radiographic Response
Hide Description Clinical activity will be assessed primarily by radiographic response of measurable disease using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease is neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study.
Time Frame Every 3 cycles x4 and then every 6 cycles (1 cycle = 28 days) until removal from protocol therapy, an average of 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Hide Arm/Group Description:
Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.

Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.

If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose
Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
Overall Number of Participants Analyzed 2 5 2
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
0
   0.0%
0
   0.0%
Partial Response
0
   0.0%
0
   0.0%
0
   0.0%
Stable Disease
1
  50.0%
2
  40.0%
1
  50.0%
Progressive Disease
1
  50.0%
3
  60.0%
1
  50.0%
2.Secondary Outcome
Title Count of Participants With Serious and Non-serious Adverse Events
Hide Description The count of participants with serious and non-serious adverse events was 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 Date treatment consent signed to date off study, approximately 32 months and 1 day.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Hide Arm/Group Description:
Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.

Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.

If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose
Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
Overall Number of Participants Analyzed 2 5 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
5
 100.0%
2
 100.0%
3.Secondary Outcome
Title Percentage of Participants Overall Survival
Hide Description Overall survival is defined as the date of on-study to the date of death from any cause or last follow up.
Time Frame Overall survival was computed using the number of months from the date of on study to the date of death, an average of 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Hide Arm/Group Description:
Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.

Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.

If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose
Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
Overall Number of Participants Analyzed 2 5 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50
(0.6 to 91)
60
(12.6 to 88.2)
50
(0.6 to 91)
4.Secondary Outcome
Title Progression Free-Survival
Hide Description Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Time Frame Patients will be evaluated approximately 60 days after last dose of investigational drug until removal of protocol therapy, an average of 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Hide Arm/Group Description:
Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.

Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.

If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose
Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
Overall Number of Participants Analyzed 1 5 2
Median (95% Confidence Interval)
Unit of Measure: Months
4
(0.6 to 91)
5.1
(1.8 to 22.5)
13.4
(2.7 to 24.1)
5.Secondary Outcome
Title Maximum Standardized Uptake Value (SUVmax) on Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)
Hide Description The maximum standardized uptake value (SUVmax) was used to measure the uptake of FDG-PET by the Gastrointestinal Tumors.
Time Frame Baseline and at a subsequent PET performed on or about day 3-6 of cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Data were only collected from patients >/= 15 years of age.
Arm/Group Title 200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Hide Arm/Group Description:
Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.

Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.

If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose
Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
Overall Number of Participants Analyzed 1 3 0
Median (Full Range)
Unit of Measure: g/mL
Baseline
22.4
(22.4 to 22.4)
21.4
(15.6 to 30.7)
Day 3-6 of cycle 1
22.0
(22.0 to 22.0)
12.4
(7.5 to 19.3)
Time Frame Date treatment consent signed to date off study, approximately 32 months and 1 day.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Hide Arm/Group Description Initially patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days. If vandetanib was tolerated at 200mg daily the dose was increased to 300mg daily. Because of excessive toxicity at the 300mg daily dose the study was amended to maintain a dose of 200mg daily in patients 18 years and older after cycle 3.

Patients 18 years and older at the time of enrollment on this study will start vandetanib at a fixed dose of 200 mg once daily (QD) for cycles 1, 2, and 3. One cycle = 28 days.

If Vandetanib was well tolerated: Cycles ≥4: 300 mg/dose

 Patients younger than 18 years of age at the time of enrollment were started at a dose of 100 mg/m^2 based on a dosing nomogram with a planned increase in the dose to 150mg/m^2/day after the third cycle if the drug was tolerated. One cycle = 28 days.
All-Cause Mortality
200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)      2/5 (40.00%)      1/2 (50.00%)    
Hide Serious Adverse Events
200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      4/5 (80.00%)      0/2 (0.00%)    
Gastrointestinal disorders       
Abdominal pain † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Stomach pain † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Nervous system disorders       
Seizure † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Vascular disorders       
Hypertension † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
200 mg Vandetanib Adult 300 mg Vandetanib Adult Dose Level 100mg/m^2 Vandetanib Pediatric
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      5/5 (100.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders       
Anemia † 1  0/2 (0.00%)  0 0/5 (0.00%)  0 1/2 (50.00%)  1
Cardiac disorders       
Electrocardiogram QT corrected interval prolonged † 1  0/2 (0.00%)  0 2/5 (40.00%)  3 0/2 (0.00%)  0
Endocrine disorders       
Hypothyroidism † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain † 1  0/2 (0.00%)  0 2/5 (40.00%)  2 0/2 (0.00%)  0
Bloating † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Diarrhea † 1  0/2 (0.00%)  0 3/5 (60.00%)  21 0/2 (0.00%)  0
Dyspepsia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Nausea † 1  0/2 (0.00%)  0 3/5 (60.00%)  10 1/2 (50.00%)  1
Oral pain † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Stomach pain † 1  0/2 (0.00%)  0 3/5 (60.00%)  5 0/2 (0.00%)  0
Vomiting † 1  0/2 (0.00%)  0 3/5 (60.00%)  4 0/2 (0.00%)  0
Mucositis oral † 1  1/2 (50.00%)  1 0/5 (0.00%)  0 0/2 (0.00%)  0
Rectal hemorrhage † 1  1/2 (50.00%)  2 0/5 (0.00%)  0 0/2 (0.00%)  0
General disorders       
Fatigue † 1  1/2 (50.00%)  1 1/5 (20.00%)  1 1/2 (50.00%)  1
Chills † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Edema limbs † 1  0/2 (0.00%)  0 1/5 (20.00%)  2 0/2 (0.00%)  0
Malaise † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Infections and infestations       
Bladder infection † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Infections and infestations - Other, not clinically significant † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Sinusitis † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Investigations       
Aspartate aminotransferase increased † 1  1/2 (50.00%)  1 4/5 (80.00%)  6 0/2 (0.00%)  0
Creatinine increased † 1  1/2 (50.00%)  1 1/5 (20.00%)  3 0/2 (0.00%)  0
Weight loss † 1  1/2 (50.00%)  1 0/5 (0.00%)  0 0/2 (0.00%)  0
Alanine aminotransferase increased † 1  0/2 (0.00%)  0 2/5 (40.00%)  2 0/2 (0.00%)  0
Alkaline phosphatase increased † 1  0/2 (0.00%)  0 2/5 (40.00%)  2 0/2 (0.00%)  0
Hemoglobin increased † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Lymphocyte count decreased † 1  0/2 (0.00%)  0 3/5 (60.00%)  6 0/2 (0.00%)  0
Neutrophil count decreased † 1  0/2 (0.00%)  0 0/5 (0.00%)  0 1/2 (50.00%)  1
Platelet count decreased † 1  0/2 (0.00%)  0 0/5 (0.00%)  0 1/2 (50.00%)  1
Metabolism and nutrition disorders       
Hypoglycemia † 1  1/2 (50.00%)  1 2/5 (40.00%)  3 0/2 (0.00%)  0
Anorexia † 1  0/2 (0.00%)  0 2/5 (40.00%)  2 0/2 (0.00%)  0
Dehydration † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Hypercalcemia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Hyperglycemia † 1  0/2 (0.00%)  0 2/5 (40.00%)  4 0/2 (0.00%)  0
Hyperkalemia † 1  0/2 (0.00%)  0 1/5 (20.00%)  2 0/2 (0.00%)  0
Hypernatremia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Hyperuricemia † 1  0/2 (0.00%)  0 3/5 (60.00%)  3 0/2 (0.00%)  0
Hypoalbuminemia † 1  0/2 (0.00%)  0 2/5 (40.00%)  3 0/2 (0.00%)  0
Hypocalcemia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 1/2 (50.00%)  1
Hypokalemia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Hypomagnesemia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Hyponatremia † 1  0/2 (0.00%)  0 2/5 (40.00%)  3 0/2 (0.00%)  0
Hypophosphatemia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Generalized muscle weakness † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify † 1 [1]  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Non-cardiac chest pain † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Nervous system disorders       
Dysgeusia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Headache † 1  0/2 (0.00%)  0 4/5 (80.00%)  9 0/2 (0.00%)  0
Psychiatric disorders       
Depression † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Insomnia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Proteinuria † 1  0/2 (0.00%)  0 4/5 (80.00%)  7 0/2 (0.00%)  0
Psychiatric disorders - Other, hypomanic † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Renal and urinary disorders       
Hematuria † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Hemoglobinuria † 1  0/2 (0.00%)  0 2/5 (40.00%)  2 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea † 1  1/2 (50.00%)  1 1/5 (20.00%)  1 0/2 (0.00%)  0
Cough † 1  0/2 (0.00%)  0 2/5 (40.00%)  2 0/2 (0.00%)  0
Hypoxia † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Pneumonitis † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Sore throat † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia † 1  2/2 (100.00%)  2 0/5 (0.00%)  0 0/2 (0.00%)  0
Dry skin † 1  1/2 (50.00%)  1 0/5 (0.00%)  0 0/2 (0.00%)  0
Pruritus † 1  1/2 (50.00%)  1 1/5 (20.00%)  1 0/2 (0.00%)  0
Rash acneiform † 1  1/2 (50.00%)  1 3/5 (60.00%)  4 2/2 (100.00%)  3
Hyperhidrosis † 1  0/2 (0.00%)  0 1/5 (20.00%)  1 0/2 (0.00%)  0
Rash maculo-papular † 1  0/2 (0.00%)  0 0/5 (0.00%)  0 1/2 (50.00%)  3
Skin and subcutaneous tissue disorders - itchiness/redness † 1  0/2 (0.00%)  0 0/5 (0.00%)  0 1/2 (50.00%)  1
Vascular disorders       
Hypertension † 1  2/2 (100.00%)  4 4/5 (80.00%)  6 0/2 (0.00%)  0
Hot flashes † 1  0/2 (0.00%)  0 1/5 (20.00%)  2 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[1]
Heaviness in the legs.
[Not Specified]
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
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Name/Title: Dr. Brigitte Widemann
Organization: National Cancer Institute
Phone: 240-760-6203
EMail: widemanb@nih.gov
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Responsible Party: Brigitte Widemann, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02015065    
Other Study ID Numbers: 130208
13-C-0208
First Submitted: December 14, 2013
First Posted: December 19, 2013
Results First Submitted: February 28, 2019
Results First Posted: July 23, 2019
Last Update Posted: March 30, 2020