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Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis After Radiosurgery for Brain Metastases

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ClinicalTrials.gov Identifier: NCT02490878
Recruitment Status : Terminated (Slow accrual)
First Posted : July 7, 2015
Results First Posted : August 6, 2021
Last Update Posted : August 6, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Radionecrosis
Brain Metastases
Interventions Drug: bevacizumab
Drug: corticosteroids
Other: placebo
Enrollment 19
Recruitment Details  
Pre-assignment Details 40 patients underwent pre-screening. Only 19 underwent randomization.
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms. The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Period Title: Overall Study
Started 10 9
Eligible Participants 10 8
Completed 10 6
Not Completed 0 3
Reason Not Completed
deemed ineligible             0             1
progression prior to treatment             0             1
only submitted baseline QOL             0             1
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo Total
Hide Arm/Group Description The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms. The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms. Total of all reporting groups
Overall Number of Baseline Participants 10 6 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age group Number Analyzed 10 participants 6 participants 16 participants
<= 65 years
7
  70.0%
5
  83.3%
12
  75.0%
> 65 years
3
  30.0%
1
  16.7%
4
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
Female
6
  60.0%
4
  66.7%
10
  62.5%
Male
4
  40.0%
2
  33.3%
6
  37.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  20.0%
0
   0.0%
2
  12.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  10.0%
0
   0.0%
1
   6.3%
White
7
  70.0%
5
  83.3%
12
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  16.7%
1
   6.3%
Prior whole brain radiotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
Yes
5
  50.0%
1
  16.7%
6
  37.5%
No
5
  50.0%
5
  83.3%
10
  62.5%
1.Primary Outcome
Title Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score
Hide Description The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Symptom Severity) is the average of the subscale items with 0 being "not present" and 10 being "as bad as you can imagine.", given that a specified minimum numbers of items were completed. A negative change in score from baseline to given time point indicates a worsening score.
Time Frame Baseline, 2, 4, 6 and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients that began protocol treatment and were assessed at baseline and at least one subsequent time within the first 8 weeks were included in this analysis.
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description:
The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Overall Number of Participants Analyzed 10 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
2 weeks Number Analyzed 10 participants 6 participants
-0.8  (1.93) 0.1  (1.24)
4 weeks Number Analyzed 8 participants 4 participants
-0.5  (2.17) -2.0  (2.53)
6 weeks Number Analyzed 8 participants 3 participants
-0.5  (2.33) -2.3  (2.86)
8 weeks Number Analyzed 7 participants 2 participants
-0.6  (2.13) -3.9  (2.83)
2.Secondary Outcome
Title Toxicity (CTCAE Version 4.0)
Hide Description Toxicity associated with bevacizumab and corticosteroids in patients with radionecrosis using CTCAE Version 4.0. The number of patients reporting a grade 3 or higher, 4 or higher, or 5 at least possibly related to treatment are included in this table.
Time Frame Up to 1.5 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began treatment are included in this endpoint
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description:
The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Overall Number of Participants Analyzed 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3 or higher
2
  20.0%
5
  62.5%
Grade 4 or higher
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Quality of Life Measure Using the Single Item Linear Analogue Scale (LASA)
Hide Description The Linear Analogue Scale used is a 5-question survey. Patients are asked to score the following questions on a 1(as bad as it can be) -10 (as good as it can be) scale: 1) your overall quality of life, 2) your overall (intellectual) well being, 3) your overall physical well being, 4) your overall emotional well being, and 5) your overall spiritual well being. The change in score was computed from baseline to 1.5 years post-treatment. A negative difference is thought of as a worsening score from baseline.
Time Frame Up to 1.5 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that completed the LASA at baseline and at 1.5 years after treatment were included in this analysis.
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description:
The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
LASA Overall Quality of Life -1.0  (3.07) 0.0  (2.55)
LASA Mental well being -1.5  (3.12) 0.0  (1.73)
LASA Physical well being -1.1  (3.4) 0.4  (1.14)
LASA Emotional well being -1.0  (2.45) 1.8  (3.03)
LASA Spiritual well being -1.1  (2.42) 0.8  (2.17)
4.Secondary Outcome
Title Quality of Life Measure Using the Dexamethasone Symptoms Questionnaire - Chronic (DSQ-C)
Hide Description The DSQ-C was developed for use in the brain tumor patient population. It consists of 18 questions rated on a 4-point scale (1 to 4, with 4 indicating a worse symptom) to indicate the presence and severity of symptoms. For each patient, the sum across all 18 questions were computed(18-72, with 18 being a score of 1 for each of the 18 questions and 72 being a score of 4 for each of the questions, refering to the previous sentence, a score of 18(a score of 1, 18 times) indicates the best possible score. A score of 72(a score of 4, 18 times) indicates the worst possible. The mean for total score across each week (weeks 2, 4, 6, 8) is reported.
Time Frame Baseline and weeks 2, 4, 6, 8 of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received protocol treatment and completed the survey at baseline were included in this analysis.
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description:
The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Overall Number of Participants Analyzed 10 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 10 participants 7 participants
1.0  (0.15) 1.2  (0.33)
Week 2 Number Analyzed 10 participants 6 participants
1.0  (0.14) 1.2  (0.23)
Week 4 Number Analyzed 8 participants 4 participants
1.0  (0.14) 1.0  (0.14)
Week 6 Number Analyzed 8 participants 3 participants
1.0  (0.07) 1.0  (0.07)
Week 8 Number Analyzed 7 participants 2 participants
1.0  (0.15) 1.0  (0.16)
5.Secondary Outcome
Title Quality of Life Measure Using the The M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Score.
Hide Description The MDASI-BT was developed and validated for use in the brain tumor patient population, including those with brain metastases and typically requires less than 4 minutes to complete. It consists of 23 symptoms rated on a 0 to 10 numerical rating scale (NRS) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." MDASI-BT Symptom Scoring: A global symptom score for the MDASI symptom severity scale is obtained by taking the average of the 23 items together. This puts the score on a 0-10 scalenumerical rating scale (NRS) to indicate the presence and severity of the symptom, with 0 being "not present" and 10 being "as bad as you can imagine." The mean global symptom at baseline and at weeks 2, 4, 6, 8 were used in this analysis.
Time Frame Up to 1.5 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment and completed the survey at study entry or within 8 weeks were included in this analysis
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description:
The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Overall Number of Participants Analyzed 10 6
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 4.0  (1.51) 5.3  (2.27)
Week 2 2.9  (2.39) 6.1  (0.88)
Week 4 3.9  (2.75) 4.8  (1.73)
Week 6 3.9  (2.21) 4.9  (3.29)
Week 8 4.0  (2.44) 4.3  (3.06)
6.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free survival is defined as the time from start of treatment to the earliest of the date patient stops placebo or bevacizumab for either alternative therapy or crossover to bevacizumab (if initially on placebo). Result will be summarized by Kaplan-Meier method.
Time Frame Up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that registered were included in this analysis.
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description:
The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Overall Number of Participants Analyzed 10 9
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [2] 
(103.0 to NA)
[1]
Too few events have been reported to obtain a median or estimate a 95% Confidence Interval
[2]
Too few events have been reported to obtain a median or estimate an upper level 95% Confidence Interval
7.Secondary Outcome
Title Time to Maximum Radiographic Response
Hide Description Time from start of treatment to maximum radiographic response
Time Frame Up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early trial termination data was not collected and could not be analyzed.
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description:
The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Time to Stopping Corticosteroids
Hide Description Time to stopping corticosteroids is defined as the time from start of protocol treatment to the last day corticosteroids were given. Time to stopping corticosteroid will be summarized by Kaplan-Meier curve with log-rank tests conducted to investigate differences between treatment arms.
Time Frame Up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that registered for treatment were included in this analysis.
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description:
The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
Overall Number of Participants Analyzed 10 9
Median (95% Confidence Interval)
Unit of Measure: days
113
(50 to 141)
102
(29 to 252)
Time Frame Adverse events were collected on days 1 and 15 during 4 cycles of treatment. Each cycle was 28 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A: Bevacizumab Arm B: Placebo
Hide Arm/Group Description The patient will receive bevacizumab 10 mg/kg IV given on days 1 and 15 of a 28 day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms. The patient will receive placebo 0.9% NaCl volume equal to bevacizumab volume added to 100 mL bag of 0.9% NaCl delivered IV given on days 1 and 15 of a 28-day cycle for 4 cycles. Once the patient has started the study treatment, the dose of corticosteroids will be tapered every 5 days (e.g., dexamethasone 2 mg or prednisone 15 mg per taper), as tolerated, under the management of the treating MD. If patients deteriorate while tapering, dexamethasone will be increased up to a maximum of 16 mg per day, as per treating MD, to manage symptoms.
All-Cause Mortality
Arm A: Bevacizumab Arm B: Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      1/8 (12.50%)    
Hide Serious Adverse Events
Arm A: Bevacizumab Arm B: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      6/8 (75.00%)    
General disorders     
Fever  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Infections and infestations     
Infections and infestations - Oth spec  1  0/10 (0.00%)  0 1/8 (12.50%)  2
Lung infection  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Sepsis  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Investigations     
Alanine aminotransferase increased  1  0/10 (0.00%)  0 1/8 (12.50%)  1
CPK increased  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Metabolism and nutrition disorders     
Hyperglycemia  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Muscle weakness lower limb  1  0/10 (0.00%)  0 2/8 (25.00%)  2
Nervous system disorders     
Depressed level of consciousness  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Dysgeusia  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Dysphasia  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Headache  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Seizure  1  0/10 (0.00%)  0 2/8 (25.00%)  3
Psychiatric disorders     
Confusion  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Vascular disorders     
Thromboembolic event  1  0/10 (0.00%)  0 1/8 (12.50%)  2
1
Term from vocabulary, MedDRA 10
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: Bevacizumab Arm B: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      8/8 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  0/10 (0.00%)  0 1/8 (12.50%)  6
Endocrine disorders     
Cushingoid  1  1/10 (10.00%)  3 0/8 (0.00%)  0
Eye disorders     
Blurred vision  1  1/10 (10.00%)  2 1/8 (12.50%)  1
Gastrointestinal disorders     
Diarrhea  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Dry mouth  1  1/10 (10.00%)  4 0/8 (0.00%)  0
Dysphagia  1  2/10 (20.00%)  4 0/8 (0.00%)  0
Gastrointestinal disorders - Oth spec  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Nausea  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Stomach pain  1  0/10 (0.00%)  0 1/8 (12.50%)  1
General disorders     
Chills  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Fatigue  1  4/10 (40.00%)  12 4/8 (50.00%)  12
Gait disturbance  1  2/10 (20.00%)  2 1/8 (12.50%)  2
Localized edema  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Malaise  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Pain  1  1/10 (10.00%)  3 1/8 (12.50%)  1
Immune system disorders     
Allergic reaction  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Injury, poisoning and procedural complications     
Bruising  1  1/10 (10.00%)  3 1/8 (12.50%)  1
Fall  1  1/10 (10.00%)  2 2/8 (25.00%)  2
Infusion related reaction  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Investigations     
Alanine aminotransferase increased  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Aspartate aminotransferase increased  1  0/10 (0.00%)  0 1/8 (12.50%)  2
Creatinine increased  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Lymphocyte count decreased  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Platelet count decreased  1  1/10 (10.00%)  2 1/8 (12.50%)  8
Weight gain  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Metabolism and nutrition disorders     
Anorexia  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Hyperglycemia  1  2/10 (20.00%)  3 1/8 (12.50%)  6
Hyperkalemia  1  0/10 (0.00%)  0 1/8 (12.50%)  2
Musculoskeletal and connective tissue disorders     
Bone pain  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Generalized muscle weakness  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Muscle weakness lower limb  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Musculoskeletal, conn tissue - Oth spec  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Myalgia  1  0/10 (0.00%)  0 1/8 (12.50%)  4
Pain in extremity  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/10 (10.00%)  2 1/8 (12.50%)  1
Dysarthria  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Dysgeusia  1  0/10 (0.00%)  0 1/8 (12.50%)  2
Facial nerve disorder  1  1/10 (10.00%)  2 0/8 (0.00%)  0
Glossopharyngeal nerve disorder  1  1/10 (10.00%)  2 0/8 (0.00%)  0
Headache  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Nervous system disorders - Oth spec  1  0/10 (0.00%)  0 1/8 (12.50%)  4
Seizure  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Trigeminal nerve disorder  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Psychiatric disorders     
Depression  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Renal and urinary disorders     
Proteinuria  1  1/10 (10.00%)  1 2/8 (25.00%)  3
Urinary incontinence  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Dyspnea  1  3/10 (30.00%)  6 0/8 (0.00%)  0
Hoarseness  1  1/10 (10.00%)  2 0/8 (0.00%)  0
Laryngeal inflammation  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Nasal congestion  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Vascular disorders     
Hypertension  1  7/10 (70.00%)  43 7/8 (87.50%)  19
Hypotension  1  1/10 (10.00%)  2 2/8 (25.00%)  2
Thromboembolic event  1  1/10 (10.00%)  7 2/8 (25.00%)  2
1
Term from vocabulary, MedDRA 10
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Caroline Chung, MD
Organization: MD Anderson Cancer Center
Phone: (713) 745-5422
EMail: cchung3@mdanderson.org
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02490878    
Obsolete Identifiers: NCT02531659
Other Study ID Numbers: A221208
NCI-2015-01348 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Submitted: July 2, 2015
First Posted: July 7, 2015
Results First Submitted: April 24, 2020
Results First Posted: August 6, 2021
Last Update Posted: August 6, 2021